Trial Outcomes & Findings for A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide (NCT NCT03151811)
NCT ID: NCT03151811
Last Updated: 2024-01-30
Results Overview
Progression Free Survival defined as the duration in months from randomization until first evidence of confirmed disease progression, as assessed by the Independent Review Committee (IRC) according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Disease progression was defined according to the IMWG-URC as progressive disease or death due to any cause, whichever occurs first.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
495 participants
Primary outcome timeframe
From date of randomization until first evidence of confirmed disease progression or death due to any cause (whichever occurred first), up to the data cutoff date of 03 Feb 2021 (ie, assessed up to approximately 43 months).
Results posted on
2024-01-30
Participant Flow
The recruitment was performed from specialized clinics' own patient pool at 115 different treatment sites in the US, Europe and Asia (20 different countries). The first patient was recruited in 12-Jun-2017 and the last patient 25-Aug-2020.
246 patients were randomized to treatment Arm A, 249 patients to treatment Arm B (FAS). Of the 495 randomized patients, 228 patients in Arm A received treatment and 246 patients in Arm B received treatment (SAF). The protocol had pre-defined treatment criteria for specific laboratory values, and if the patient's values deteriorated between screening and C1D1, treatment could not be initiated. In total, 664 patients were screened, 495 randomized, 474 treated, 21 randomized but not treated.
Participant milestones
| Measure |
Arm A: Melflufen+Dexamethasone
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
|---|---|---|
|
Overall Study
STARTED
|
246
|
249
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
246
|
249
|
Reasons for withdrawal
| Measure |
Arm A: Melflufen+Dexamethasone
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
|---|---|---|
|
Overall Study
Randomized But Not Treated
|
18
|
3
|
|
Overall Study
Progressive Disease
|
130
|
170
|
|
Overall Study
Adverse Event
|
49
|
40
|
|
Overall Study
Lack of Efficacy
|
6
|
8
|
|
Overall Study
Physician Decision
|
21
|
9
|
|
Overall Study
Withdrawal by Subject
|
17
|
7
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Study Terminated by Sponsor
|
5
|
11
|
Baseline Characteristics
A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide
Baseline characteristics by cohort
| Measure |
Arm A: Melflufen+Dexamethasone
n=246 Participants
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
n=249 Participants
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
Total
n=495 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
150 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
68 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
232 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
469 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
224 Participants
n=5 Participants
|
222 Participants
n=7 Participants
|
446 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
40 participants
n=5 Participants
|
39 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
14 participants
n=5 Participants
|
19 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
France
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Lithuania
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until first evidence of confirmed disease progression or death due to any cause (whichever occurred first), up to the data cutoff date of 03 Feb 2021 (ie, assessed up to approximately 43 months).Population: All randomized patients (Full Analysis Set as per protocol) were included into the primary outcome measure analysis.
Progression Free Survival defined as the duration in months from randomization until first evidence of confirmed disease progression, as assessed by the Independent Review Committee (IRC) according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Disease progression was defined according to the IMWG-URC as progressive disease or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Arm A: Melflufen+Dexamethasone
n=246 Participants
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
n=249 Participants
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
|---|---|---|
|
Progression Free Survival (PFS)
|
6.83 months
Interval 4.96 to 8.54
|
4.93 months
Interval 4.24 to 5.72
|
SECONDARY outcome
Timeframe: From randomization until best response achieved before confirmed disease progression or death due to any cause, up to data cutoff of 03 Feb 2021 (ie, assessed up to approx. 43 months). Median time to best response: Arm A=2.1 months and Arm B=2.0 monthsPopulation: Full Analysis Set
ORR defined as the proportion of patients for whom the best overall confirmed response is stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by IRC.
Outcome measures
| Measure |
Arm A: Melflufen+Dexamethasone
n=246 Participants
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
n=249 Participants
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
|---|---|---|
|
Overall Response Rate (ORR)
|
80 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: From first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause, up to the data cutoff date of 03 Feb 2021 (ie, assessed up to approximately 43 months).Population: Full Analysis Set (all patients randomized to either Arm A or Arm B).
DOR defined as the duration in months from first documentation of a confirmed response to first evidence of confirmed disease progression or death due to any cause.
Outcome measures
| Measure |
Arm A: Melflufen+Dexamethasone
n=246 Participants
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
n=249 Participants
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
|---|---|---|
|
Duration of Response (DOR)
|
11.17 months
Interval 8.48 to 17.48
|
11.07 months
Interval 7.62 to 15.44
|
SECONDARY outcome
Timeframe: From date of randomization until up to 24 months following confirmed disease progression or initiation of subsequent therapy, up to the data cutoff date of 03 Feb 2023 (ie, assessed up to approximately 67 months).Population: Full Analysis Set (all patients randomized to either Arm A or Arm B).
OS defined as the time in months from randomization to date of death due to any cause. Patients who were still alive at end of study, or lost to follow up, were censored at the last day the patient was known to be alive.
Outcome measures
| Measure |
Arm A: Melflufen+Dexamethasone
n=246 Participants
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
n=249 Participants
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
|---|---|---|
|
Overall Survival (OS)
|
20.24 Months
Interval 15.84 to 24.15
|
23.98 Months
Interval 18.92 to 27.86
|
SECONDARY outcome
Timeframe: From start of dosing until 30 days after the last dose of study treatment, up to the data cutoff date of 03 Feb 2023 (ie, assessed up to approximately 67 months). Median duration of study treatment was 25.2 and 22.1 weeks for Arm A and B, respectively.Population: Safety Analysis Set (all patients that have received at least one dose of study drug in either Arm A or Arm B).
Number of patients with TEAEs, including clinical laboratory and vital signs abnormalities, as assessed by CTCAE v4.0 are presented. No formal statistical analysis was performed for safety endpoints.
Outcome measures
| Measure |
Arm A: Melflufen+Dexamethasone
n=228 Participants
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
n=246 Participants
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
|---|---|---|
|
Safety and Tolerability: Number of Patients With Treatment-emergent Adverse Events (TEAEs), Including Clinical Laboratory and Vital Signs Abnormalities, as Assessed by CTCAE v4.0
|
227 Participants
|
243 Participants
|
Adverse Events
Arm A: Melflufen+Dexamethasone
Serious events: 99 serious events
Other events: 227 other events
Deaths: 180 deaths
Arm B: Pomalidomide+Dexamethasone
Serious events: 124 serious events
Other events: 243 other events
Deaths: 169 deaths
Serious adverse events
| Measure |
Arm A: Melflufen+Dexamethasone
n=228 participants at risk
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
n=246 participants at risk
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
6.1%
14/228 • Number of events 17 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
9.3%
23/246 • Number of events 26 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
COVID-19 pneumonia
|
5.3%
12/228 • Number of events 13 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
5.7%
14/246 • Number of events 14 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Urinary tract infection
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
2.4%
6/246 • Number of events 11 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Sepsis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
2.4%
6/246 • Number of events 6 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Bronchitis
|
1.3%
3/228 • Number of events 4 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.6%
4/246 • Number of events 5 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Influenzae
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
2.0%
5/246 • Number of events 5 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.3%
3/228 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Viral Infection
|
0.44%
1/228 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 4 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Respiratory tract infection
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Septic shock
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Escherichia sepsis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Gastroenteritis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Infection
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Abscess
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Abscess jaw
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Arthritis fungal
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Bacteraemia
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Bacterial sepsis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Bronchiolitis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Lymphangitis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Moraxella infection
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Muscle abscess
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Oral herpes
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Orchitis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
8/228 • Number of events 11 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
2.4%
6/246 • Number of events 13 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
11/228 • Number of events 15 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.2%
5/228 • Number of events 6 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.8%
4/228 • Number of events 5 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
General physical health deterioration
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.6%
4/246 • Number of events 5 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Pyrexia
|
2.2%
5/228 • Number of events 6 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Asthenia
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Chest Pain
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Pain
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Sudden cardiac death
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Administration site extravasion
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Death
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Fatigue
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Sudden death
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
4/228 • Number of events 4 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.6%
4/246 • Number of events 4 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pumlonary embolism
|
1.8%
4/228 • Number of events 4 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.6%
4/246 • Number of events 4 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.44%
1/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
3.7%
9/246 • Number of events 11 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Cardiac arrest
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Cardiac failure
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Coronary artery disease
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Angina unstable
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Atrial flutter
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Atrioventricular block
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Cardiac failure acute
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Oesophageal injury
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Abdominal mass
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Cholitis ischaemic
|
0.44%
1/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Melaena
|
0.44%
1/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Colitis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Oral mucosal hypertrophy
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Renal and urinary disorders
Renal Failure
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
2.4%
6/246 • Number of events 6 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
2.0%
5/246 • Number of events 5 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Renal and urinary disorders
Haematuria
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 4 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Vertebral lesion
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Brain oedema
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Cerebral infarction
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Ischaemic stroke
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Syncope
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.6%
4/246 • Number of events 4 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Investigations
Platelet count decreased
|
1.8%
4/228 • Number of events 5 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Investigations
Neutrophil count decreased
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Investigations
Hepatic enzyme increased
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.81%
2/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Vascular disorders
Haematoma
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Vascular disorders
Hypertension
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Immune system disorders
Hypersensitivity
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Psychiatric disorders
Confusional state
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
COVID-19
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
1.2%
3/246 • Number of events 3 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Device related sepsis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Rhinovirus infection
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Pathological fracture
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Post stroke epilepsy
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.44%
1/228 • Number of events 1 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.00%
0/246 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/228 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
0.41%
1/246 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
Other adverse events
| Measure |
Arm A: Melflufen+Dexamethasone
n=228 participants at risk
Melflufen 40 mg i.v. on Day 1 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Melflufen: Intravenous infusion
Dexamethasone: Oral tablets
|
Arm B: Pomalidomide+Dexamethasone
n=246 participants at risk
Pomalidomide 4 mg orally daily on Days 1 to 21 and dexamethasone 40 mg (20 mg for patients ≥ 75 years of age) on Days 1, 8, 15 and 22 of each 28-day cycle. Patients were to be treated until confirmed progression, unacceptable toxicity, or the patient or investigator decided it was not in the patient's best interest to continue.
Pomalidomide: Oral capsules
Dexamethasone: Oral tablets
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
60.1%
137/228 • Number of events 795 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
46.7%
115/246 • Number of events 421 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Blood and lymphatic system disorders
Anaemia
|
67.5%
154/228 • Number of events 487 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
39.4%
97/246 • Number of events 238 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
70.6%
161/228 • Number of events 918 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
20.3%
50/246 • Number of events 149 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.5%
24/228 • Number of events 89 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
4.5%
11/246 • Number of events 18 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Diarrhoea
|
14.0%
32/228 • Number of events 46 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
9.8%
24/246 • Number of events 32 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Nausea
|
13.6%
31/228 • Number of events 44 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
7.3%
18/246 • Number of events 20 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Gastrointestinal disorders
Constipation
|
7.5%
17/228 • Number of events 19 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
11.8%
29/246 • Number of events 33 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Fatigue
|
14.5%
33/228 • Number of events 52 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
17.9%
44/246 • Number of events 57 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Asthenia
|
14.5%
33/228 • Number of events 50 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
13.0%
32/246 • Number of events 47 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Pyrexia
|
14.5%
33/228 • Number of events 43 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
7.3%
18/246 • Number of events 25 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
General disorders
Oedema peripheral
|
5.3%
12/228 • Number of events 17 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
9.8%
24/246 • Number of events 24 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Upper respiratory tract infection
|
12.7%
29/228 • Number of events 33 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
11.0%
27/246 • Number of events 43 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Bronchitis
|
5.7%
13/228 • Number of events 16 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
11.8%
29/246 • Number of events 42 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Pneumonia
|
9.2%
21/228 • Number of events 26 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
14.6%
36/246 • Number of events 47 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Urinary tract infection
|
5.3%
12/228 • Number of events 17 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
6.5%
16/246 • Number of events 24 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
Respiratory tract infection
|
3.5%
8/228 • Number of events 12 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
8.1%
20/246 • Number of events 24 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Infections and infestations
COVID-19 pneumonia
|
5.3%
12/228 • Number of events 15 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
5.7%
14/246 • Number of events 16 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Investigations
Neutrophil count decreased
|
13.2%
30/228 • Number of events 154 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
11.4%
28/246 • Number of events 88 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Investigations
Platelet count decreased
|
17.5%
40/228 • Number of events 198 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
4.5%
11/246 • Number of events 25 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Investigations
White blood cell count decreased
|
9.6%
22/228 • Number of events 86 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
2.4%
6/246 • Number of events 9 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Investigations
SARS-CoV-2 test positive
|
7.0%
16/228 • Number of events 17 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
8.9%
22/246 • Number of events 26 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
19/228 • Number of events 20 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
10.6%
26/246 • Number of events 33 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.0%
16/228 • Number of events 18 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
5.3%
13/246 • Number of events 19 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
7.0%
16/228 • Number of events 20 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
3.3%
8/246 • Number of events 9 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Nervous system disorders
Dizziness
|
3.5%
8/228 • Number of events 9 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
6.5%
16/246 • Number of events 21 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Psychiatric disorders
Insomnia
|
9.2%
21/228 • Number of events 23 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
8.5%
21/246 • Number of events 29 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.6%
22/228 • Number of events 27 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
11.0%
27/246 • Number of events 28 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
20/228 • Number of events 24 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
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8.1%
20/246 • Number of events 30 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
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Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
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0.88%
2/228 • Number of events 2 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
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5.7%
14/246 • Number of events 15 • Deaths were recorded from time of randomization until death or withdrawal from study and TEAEs were recorded from start of treatment until 30 days after the last dose of study drug, up to the data cutoff of 03 Feb 2023 (ie, assessed up to approx. 67 months). Eligibility for treatment was reconfirmed on C1D1, resulting in 18 patients never treated in Arm A and 3 patients in Arm B. Patients were treated in 28-day cycles indefinitely until withdrawal from study. Longest time on study was 60 months.
All-cause mortality is reported for the Full Analysis Set (all randomized patients; Arm A=246 patients, Arm B=249 patients). Adverse Events are reported for the Safety Analysis Set (all patients who received at least one or partial dose of melflufen, pomalidomide, or dexamethasone; Arm A=228 patients, Arm B=246 patients). Non-serious AEs were not calculated in this study. Data reported in the "Other Adverse Events" section include all TEAEs (non-serious AEs and serious AEs).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place