Trial Outcomes & Findings for A PK, Safety and Tolerability Study of Peripheral and Central Infusion of Melflufen in RRMM Patients (NCT NCT04412707)
NCT ID: NCT04412707
Last Updated: 2023-03-09
Results Overview
To evaluate and compare the pharmacokinetic (PK) variable Cmax of melphalan after central and peripheral intravenous infusion of melflufen.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Cycle 1 Day 1 and Cycle 2 Day 1. Samples were collected 5, 10, 15, 20, and 25 minutes after the start of the infusion; immediately before the end of the infusion; and 5, 10, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.
Results posted on
2023-03-09
Participant Flow
Participant milestones
| Measure |
Arm A
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
Arm B
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
|---|---|---|
|
Cycle 1
STARTED
|
14
|
13
|
|
Cycle 1
Discontinued
|
1
|
5
|
|
Cycle 1
COMPLETED
|
13
|
8
|
|
Cycle 1
NOT COMPLETED
|
1
|
5
|
|
Cycle 2
STARTED
|
13
|
8
|
|
Cycle 2
Discontinued
|
3
|
1
|
|
Cycle 2
COMPLETED
|
10
|
7
|
|
Cycle 2
NOT COMPLETED
|
3
|
1
|
|
Cycle 3 to End of Study (EOS)
STARTED
|
10
|
7
|
|
Cycle 3 to End of Study (EOS)
Ongoing in Study at Data Cut
|
0
|
0
|
|
Cycle 3 to End of Study (EOS)
Discontinued Study in Cycle 3 or Later
|
10
|
7
|
|
Cycle 3 to End of Study (EOS)
COMPLETED
|
0
|
0
|
|
Cycle 3 to End of Study (EOS)
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Arm A
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
Arm B
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
|---|---|---|
|
Cycle 1
Death
|
0
|
3
|
|
Cycle 1
Disease progression
|
1
|
2
|
|
Cycle 2
Death
|
0
|
1
|
|
Cycle 2
Disease progression
|
3
|
0
|
|
Cycle 3 to End of Study (EOS)
Death
|
1
|
3
|
|
Cycle 3 to End of Study (EOS)
Disease progression
|
4
|
2
|
|
Cycle 3 to End of Study (EOS)
Study terminated by Sponsor
|
4
|
2
|
|
Cycle 3 to End of Study (EOS)
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Percentages are based on the number of female participants only.
Baseline characteristics by cohort
| Measure |
Arm A
n=14 Participants
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
Arm B
n=13 Participants
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age group · <65 years
|
8 Participants
n=14 Participants
|
4 Participants
n=13 Participants
|
12 Participants
n=27 Participants
|
|
Age, Customized
Age group · >=65 - 75 years
|
5 Participants
n=14 Participants
|
5 Participants
n=13 Participants
|
10 Participants
n=27 Participants
|
|
Age, Customized
Age group · > 75 years
|
1 Participants
n=14 Participants
|
4 Participants
n=13 Participants
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=14 Participants
|
7 Participants
n=13 Participants
|
14 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=14 Participants
|
6 Participants
n=13 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=14 Participants
|
13 Participants
n=13 Participants
|
26 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=14 Participants
|
13 Participants
n=13 Participants
|
27 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=14 Participants
|
3 participants
n=13 Participants
|
4 participants
n=27 Participants
|
|
Region of Enrollment
Czechia
|
4 participants
n=14 Participants
|
7 participants
n=13 Participants
|
11 participants
n=27 Participants
|
|
Region of Enrollment
Ukraine
|
3 participants
n=14 Participants
|
2 participants
n=13 Participants
|
5 participants
n=27 Participants
|
|
Region of Enrollment
Bulgaria
|
6 participants
n=14 Participants
|
1 participants
n=13 Participants
|
7 participants
n=27 Participants
|
|
Baseline fertility status
Potentially able to bear children
|
1 Participants
n=7 Participants • Percentages are based on the number of female participants only.
|
0 Participants
n=7 Participants • Percentages are based on the number of female participants only.
|
1 Participants
n=14 Participants • Percentages are based on the number of female participants only.
|
|
Baseline fertility status
Not able to bear children
|
6 Participants
n=7 Participants • Percentages are based on the number of female participants only.
|
7 Participants
n=7 Participants • Percentages are based on the number of female participants only.
|
13 Participants
n=14 Participants • Percentages are based on the number of female participants only.
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1. Samples were collected 5, 10, 15, 20, and 25 minutes after the start of the infusion; immediately before the end of the infusion; and 5, 10, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) Set: All patients that received at least two melflufen doses of 40 mg and had sufficient PK samples taken at Cycle 1 and 2 for determination of all PK variables. One PK sampling series following peripheral administration and one PK sampling series following central administration. Patients with a dose reduction in cycle 2 were not evaluable for PK.
To evaluate and compare the pharmacokinetic (PK) variable Cmax of melphalan after central and peripheral intravenous infusion of melflufen.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=21 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=21 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
Arm A plus Arm B
|
|---|---|---|---|
|
Peak Plasma Concentration for Melphalan
Cycle 1
|
486.1 ng/mL
Geometric Coefficient of Variation 21.34
|
530.1 ng/mL
Geometric Coefficient of Variation 25.23
|
—
|
|
Peak Plasma Concentration for Melphalan
Cycle 2
|
546.3 ng/mL
Geometric Coefficient of Variation 31.83
|
449.2 ng/mL
Geometric Coefficient of Variation 40.66
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1. Samples were collected 5, 10, 15, 20, and 25 minutes after the start of the infusion; immediately before the end of the infusion; and 5, 10, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) Set: All patients that received at least two melflufen doses of 40 mg and had sufficient PK samples taken at Cycle 1 and 2 for determination of all PK variables. One PK sampling series following peripheral administration and one PK sampling series following central administration. Patients with a dose reduction in cycle 2 were not evaluable for PK.
To evaluate and compare the pharmacokinetic (PK) variable AUC(0-t) of melphalan after central and peripheral intravenous infusion of melflufen.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=21 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=21 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
Arm A plus Arm B
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-t) of Melphalan
Cycle 1
|
49518.36 min*ng/mL
Geometric Coefficient of Variation 23.710
|
59543.20 min*ng/mL
Geometric Coefficient of Variation 17.698
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-t) of Melphalan
Cycle 2
|
60273.95 min*ng/mL
Geometric Coefficient of Variation 30.037
|
46173.13 min*ng/mL
Geometric Coefficient of Variation 43.336
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1. Samples were collected 5, 10, 15, 20, and 25 minutes after the start of the infusion; immediately before the end of the infusion; and 5, 10, 15, and 30 minutes and 1, 2, and 4 hours after the end of the infusion.Population: Pharmacokinetic (PK) Set: All patients that received at least two melflufen doses of 40 mg and had sufficient PK samples taken at Cycle 1 and 2 for determination of all PK variables. One PK sampling series following peripheral administration and one PK sampling series following central administration. Patients with a dose reduction in cycle 2 were not evaluable for PK.
To evaluate and compare the pharmacokinetic (PK) variable AUC(0-inf) of melphalan after central and peripheral intravenous infusion of melflufen
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=21 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=21 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
Arm A plus Arm B
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-inf) of Melphalan
Cycle 1
|
54216.70 min*ng/mL
Geometric Coefficient of Variation 23.794
|
66835.47 min*ng/mL
Geometric Coefficient of Variation 18.171
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-inf) of Melphalan
Cycle 2
|
67403.07 min*ng/mL
Geometric Coefficient of Variation 30.149
|
50835.59 min*ng/mL
Geometric Coefficient of Variation 44.728
|
—
|
PRIMARY outcome
Timeframe: 15 minutes and 4 hours after peripheral intravenous administration, pre- and post-infusion on Day 1 and Day 8Population: Safety Analysis Set
Assessment of the local tolerability of peripheral intravenous administration of melflufen using the Visual Infusion Phlebitis (VIP) scale. The VIP scale provides a score from 0 to 5, noting an ascending order of severity of inflammation. A score of 0 is the lowest possible score, meaning no inflammation detected, and 5 is the highest score, indicating the most severe reaction.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=27 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
Arm A plus Arm B
|
|---|---|---|---|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Pre-Infusion · VIP score = 0
|
13 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Pre-Infusion · VIP score = 1
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Pre-Infusion · VIP score = 2
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Pre-Infusion · VIP score = 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Pre-Infusion · VIP score = 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Pre-Infusion · VIP score = 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Post-Infusion · VIP score = 0
|
13 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Post-Infusion · VIP score = 1
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Post-Infusion · VIP score = 2
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Post-Infusion · VIP score = 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Post-Infusion · VIP score = 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 1 Post-Infusion · VIP score = 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 8 · VIP score = 0
|
10 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 8 · VIP score = 1
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 8 · VIP score = 2
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 8 · VIP score = 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 8 · VIP score = 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 1 Day 8 · VIP score = 5
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 2 Day 1 Pre-Infusion · VIP score = 0
|
8 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 2 Day 1 Pre-Infusion · VIP score = 1
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 2 Day 1 Pre-Infusion · VIP score = 2
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 2 Day 1 Pre-Infusion · VIP score = 3
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 2 Day 1 Pre-Infusion · VIP score = 4
|
0 Participants
|
—
|
—
|
|
Number of Participants With Local Reactions Including Phlebitis at Infusion Site After Peripheral Intravenous Administration
Cycle 2 Day 1 Pre-Infusion · VIP score = 5
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 - 13 PK samples during and post infusion (28 days cycle)Population: Pharmacokinetic (PK) Analysis set: All patients that received at least two melflufen doses of 40 mg and had sufficient PK samples taken at Cycle 1 and 2 for determination of all PK variables. One PK sampling series following peripheral administration and one PK sampling series following central administration. Patients with a dose reduction in cycle 2 were not evaluable for PK.
To evaluate and compare the pharmacokinetic (PK) variable Cmax of melflufen and desethyl-melflufen after central and peripheral intravenous infusion of melflufen.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=21 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=21 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
Arm A plus Arm B
|
|---|---|---|---|
|
Peak Plasma Concentration for Melflufen and Desethyl-melflufen
Melflufen Cycle 1
|
151.11 ng/mL
Geometric Coefficient of Variation 59.74
|
123.0 ng/mL
Geometric Coefficient of Variation 47.498
|
—
|
|
Peak Plasma Concentration for Melflufen and Desethyl-melflufen
Melflufen Cycle 2
|
127.27 ng/mL
Geometric Coefficient of Variation 75.872
|
141.75 ng/mL
Geometric Coefficient of Variation 47.921
|
—
|
|
Peak Plasma Concentration for Melflufen and Desethyl-melflufen
Desethyl-melflufen Cycle 1
|
16.721 ng/mL
Geometric Coefficient of Variation 33.2618
|
11.851 ng/mL
Geometric Coefficient of Variation 41.3587
|
—
|
|
Peak Plasma Concentration for Melflufen and Desethyl-melflufen
Desethyl-melflufen Cycle 2
|
16.801 ng/mL
Geometric Coefficient of Variation 43.8965
|
11.851 ng/mL
Geometric Coefficient of Variation 41.3587
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 - 13 PK samples during and post infusion (28 days cycle)Population: Pharmacokinetic (PK) analysis set: All patients that received at least two melflufen doses of 40 mg and had sufficient PK samples taken at Cycle 1 and 2 for determination of all PK variables. One PK sampling series following peripheral administration and one PK sampling series following central administration. Patients with a dose reduction in cycle 2 were not evaluable for PK.
To evaluate and compare the pharmacokinetic (PK) variable AUC(0-t) of melflufen and desethyl-melflufen after central and peripheral intravenous infusion of melflufen
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=21 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=21 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
Arm A plus Arm B
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-t) of Melflufen and Desethyl-melflufen
Melflufen Cycle 1 (0-t)
|
3617.03 min x ng/mL
Geometric Coefficient of Variation 52.244
|
2828.69 min x ng/mL
Geometric Coefficient of Variation 51.646
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-t) of Melflufen and Desethyl-melflufen
Melflufen Cycle 2 (0-t)
|
3083.74 min x ng/mL
Geometric Coefficient of Variation 80.639
|
3078.21 min x ng/mL
Geometric Coefficient of Variation 49.443
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-t) of Melflufen and Desethyl-melflufen
Desethyl-melflufen Cycle 1 (0-t)
|
563.34 min x ng/mL
Geometric Coefficient of Variation 42.086
|
639.39 min x ng/mL
Geometric Coefficient of Variation 34.053
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-t) of Melflufen and Desethyl-melflufen
Desethyl-melflufen Cycle 2 (0-t)
|
636.06 min x ng/mL
Geometric Coefficient of Variation 51.627
|
391.11 min x ng/mL
Geometric Coefficient of Variation 49.458
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 - 13 PK samples during and post infusion (28 days cycle)Population: Pharmacokinetic (PK) Analysis set: All patients that received at least two melflufen doses of 40 mg and had sufficient PK samples taken at Cycle 1 and 2 for determination of all PK variables. One PK sampling series following peripheral administration and one PK sampling series following central administration. Patients with a dose reduction in Cycle 2 were not evaluable for PK.
To evaluate and compare the pharmacokinetic (PK) variable AUC(0-inf) of melflufen and desethyl-melflufen after central and peripheral intravenous infusion of melflufen
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=21 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=21 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
Arm A plus Arm B
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-inf) of Melflufen and Desethyl-melflufen
Melflufen Cycle 1 (0-inf)
|
3639.34 min x ng/mL
Geometric Coefficient of Variation 52.379
|
2841.23 min x ng/mL
Geometric Coefficient of Variation 51.631
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-inf) of Melflufen and Desethyl-melflufen
Meflufen Cycle 2 (0-inf)
|
3099.70 min x ng/mL
Geometric Coefficient of Variation 80.708
|
3093.96 min x ng/mL
Geometric Coefficient of Variation 49.295
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-inf) of Melflufen and Desethyl-melflufen
Desethyl-melflufen Cycle 1 (0-inf)
|
609.44 min x ng/mL
Geometric Coefficient of Variation 40.778
|
759.25 min x ng/mL
Geometric Coefficient of Variation 34.619
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve AUC(0-inf) of Melflufen and Desethyl-melflufen
Desethyl-melflufen Cycle 2 (0-inf)
|
695.29 min x ng/mL
Geometric Coefficient of Variation 51.722
|
440.65 min x ng/mL
Geometric Coefficient of Variation 43.547
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Cycle 2 Day 1 - 13 measurements during and post infusion (28 days cycle)Population: Pharmacokinetic (PK) Analysis set:All patients that received at least two melflufen doses of 40 mg and had sufficient PK samples taken at Cycle 1 and 2 for determination of all PK variables. One PK sampling series following peripheral administration and one PK sampling series following central administration. Patients with a dose reduction in cycle 2 were not evaluable for PK.
To evaluate elimination half-life (t½) for melflufen, melphalan and desethyl-melflufen after central and peripheral intravenous infusion of melflufen.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=21 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=21 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
Arm A plus Arm B
|
|---|---|---|---|
|
Elimination Half-life (t1/2) of Melflufen, Melphalan and Desethyl-melflufen
Desethyl-melflufen Cycle 2
|
25.04 minutes
Standard Deviation 83.298
|
17.43 minutes
Standard Deviation 37.708
|
—
|
|
Elimination Half-life (t1/2) of Melflufen, Melphalan and Desethyl-melflufen
Melphalan Cycle 1
|
72.51 minutes
Standard Deviation 14.993
|
80.09 minutes
Standard Deviation 12.85
|
—
|
|
Elimination Half-life (t1/2) of Melflufen, Melphalan and Desethyl-melflufen
Melphalan Cycle 2
|
78.09 minutes
Standard Deviation 18.118
|
72.97 minutes
Standard Deviation 16.84
|
—
|
|
Elimination Half-life (t1/2) of Melflufen, Melphalan and Desethyl-melflufen
Melflufen Cycle 1
|
7.42 minutes
Standard Deviation 106.832
|
4.45 minutes
Standard Deviation 90.634
|
—
|
|
Elimination Half-life (t1/2) of Melflufen, Melphalan and Desethyl-melflufen
Melflufen Cycle 2
|
6.15 minutes
Standard Deviation 81.278
|
5.74 minutes
Standard Deviation 80.837
|
—
|
|
Elimination Half-life (t1/2) of Melflufen, Melphalan and Desethyl-melflufen
Desethyl-melflufen Cycle 1
|
18.44 minutes
Standard Deviation 49.68
|
23.49 minutes
Standard Deviation 43.423
|
—
|
SECONDARY outcome
Timeframe: Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.To assess safety and general tolerability of melflufen by collecting non-serious Adverse Events (AEs) from the start of study treatment until 30 days after the last dose of any study drug (melflufen or dexamethasone) or initiation of subsequent therapy whichever occurred first. Serious AEs (SAEs) were collected from the time the subject signed the ICF until 30 days after the last dose of any study drug (melflufen or dexamethasone) or initiation of subsequent therapy whichever occurred first.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Patients with at least 1 TEAE
|
13 Participants
|
13 Participants
|
26 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Blood and lymphatic system disorders
|
13 Participants
|
12 Participants
|
25 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Thrombocytopenia
|
10 Participants
|
10 Participants
|
20 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Neutropenia
|
9 Participants
|
9 Participants
|
18 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Anaemia
|
9 Participants
|
7 Participants
|
16 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Leukopenia
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Infections and Infestations
|
6 Participants
|
7 Participants
|
13 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Pneumonia
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
COVID-19 pneumonia
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Respiratory tract infection
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
General disorders and administration site conditions
|
5 Participants
|
6 Participants
|
11 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Pyrexia
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Fatigue
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
General health deterioration
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Musculoskeletal and connective tissue disorders
|
4 Participants
|
5 Participants
|
9 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Arthralgia
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Back pain
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Bone pain
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Investigations
|
4 Participants
|
4 Participants
|
8 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
SARS-CoV-2 test positive
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
C-reactive protein increased
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Injury, poisoning and procedural complications
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
femur fracture
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Skin and subcutaneous tissue disorders
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Frequency of Treatment-Emergent Adverse Events (TEAEs) by MedDRA SOC and PT
Rash
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From initiation of therapy until disease progression. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively.Population: Full Analysis Set: 14 participants randomized to Arm A and 13 participants randomized to Arm B.
To assess best response during the study with the criteria established by the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) for sCR, CR, VGPR, PR, SD and PD
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
Best Response (Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
Stringent complete response
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Response (Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
Complete response
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Best Response (Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
Very good partial response
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Response (Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
Partial response
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Best Response (Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
Minimal response
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Best Response (Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
Stable disease
|
2 Participants
|
6 Participants
|
8 Participants
|
|
Best Response (Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
Progressive disease
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Best Response (Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD)
Not available
|
2 Participants
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From initiation of therapy until disease progression. Maximum treatment durations for Arm A and Arm B were 68.4 and 59.0 weeks, respectively.Population: Full Analysis set: 14 participants randomized to Arm A and 13 participants randomized to Arm B.
To assess overall response rate (ORR), including CR/sCR, VGPR and PR, during the study with the criteria established by the IMWG-URC.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
ORR
|
4 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: To be assessed at the end of study drug treatment. Maximum treatment durations for Arm A and Arm B were 68.4 and 59.0 weeks, respectively.Population: Full Analysis set: 14 participants randomized to Arm A and 13 participants randomized to Arm B.
To assess clinical benefit rate (CBR), i.e., proportion of patients that achieve a confirmed minimal response or better (sCR, CR, VGPR, PR and MR), during the study with the criteria established by the IMWG-URC.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
CBR
|
8 Participants
|
2 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From confirmed response until disease progression. Maximum treatment durations for Arm A and Arm B were 68.4 and 59.0 weeks, respectively.Population: Full Analysis set: 14 participants randomized to Arm A and 13 participants randomized to Arm B.
To assess duration of response (DOR): the time in months from the first evidence of confirmed assessment of sCR, CR, VGPR, or PR to first confirmed disease progression according to the criteria established by the IMWG-URC or to death due to any cause. DOR is defined only for patients with a confirmed PR or better.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
DOR
|
NA months
Interval 1.18 to
Note: At study termination, the DOR data was insufficient to evaluate due to the low number of patient events: 1 (7.1%) in Arm A, 0 in Arm B.
|
NA months
Note: At study termination, the DOR data was insufficient to evaluate due to the low number of patient events: 1 (7.1%) in Arm A, 0 in Arm B.
|
NA months
Interval 1.18 to
Note: At study termination, the DOR data was insufficient to evaluate due to the low number of patient events: 1 (7.1%) in Arm A, 0 in Arm B.
|
SECONDARY outcome
Timeframe: From first evidence of confirmed assessment of sCR, CR, VGPR, PR or MR to first confirmed disease progression, or to death due to any cause. Maximum treatment durations for Arm A and Arm B were 68.4 and 59.0 weeks, respectively.Population: Full Analysis set: 14 participants randomized to Arm A and 13 participants randomized to Arm B.
To assess duration of clinical benefit (DOCB) in patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), PR, or MR during the study with the criteria established by the IMWG-URC.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
DOCB
|
NA months
Interval 3.02 to
Overall, 3 patients had experienced an event and 7 had been censored, as they were alive and without a PD assessment at the time of study termination. Consequently, the DOCB data was insufficient to evaluate.
|
NA months
Overall, 3 patients had experienced an event and 7 had been censored, as they were alive and without a PD assessment at the time of study termination. Consequently, the DOCB data was insufficient to evaluate.
|
NA months
Interval 7.16 to
Overall, 3 patients had experienced an event and 7 had been censored, as they were alive and without a PD assessment at the time of study termination. Consequently, the DOCB data was insufficient to evaluate.
|
SECONDARY outcome
Timeframe: From initiation of therapy until documented disease response. Maximum treatment durations for Arm A and Arm B were 68.4 and 59.0 weeks, respectively.Population: Full Analysis set:14 participants randomized to Arm A and 13 participants randomized to Arm B.
To assess time to response (TTR) in patients with PR or better during the study with the criteria established by the UMWG-URC.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
TTR
|
4 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From date of randomization until documented disease progression. Maximum treatment durations for Arm A and Arm B were 68.4 and 59.0 weeks, respectively.Population: Full Analysis set: 14 participants randomized to Arm A and 13 participants randomized to Arm B.
To assess time to progression (TTP) during the study with the criteria established by the IMWG-URC.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
TTP
|
5.78 months
Interval 2.73 to
Overall, 13 (48.1%) patients had experienced progression and 14 (51.9%) were censored, as they were alive and lacked PD assessments or documentation at the time of study termination
|
4.80 months
Interval 2.79 to
Overall, 13 (48.1%) patients had experienced progression and 14 (51.9%) were censored, as they were alive and lacked PD assessments or documentation at the time of study termination
|
5.78 months
Interval 3.06 to
Overall, 13 (48.1%) patients had experienced progression and 14 (51.9%) were censored, as they were alive and lacked PD assessments or documentation at the time of study termination
|
SECONDARY outcome
Timeframe: From randomization to the date of next anti-myeloma treatment. Maximum treatment durations for Arm A and Arm B were 68.4 and 59.0 weeks, respectively.Population: Full Analysis set: 14 participants randomized to Arm A and 13 participants randomized to Arm B.
To assess time to next treatment (TTNT)
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
TTNT
|
NA months
In this study, patients were followed to progression. No patients had a new treatment for MM prior to progression, and as a result TTNT was not calculable.
|
NA months
In this study, patients were followed to progression. No patients had a new treatment for MM prior to progression, and as a result TTNT was not calculable.
|
NA months
In this study, patients were followed to progression. No patients had a new treatment for MM prior to progression, and as a result TTNT was not calculable.
|
SECONDARY outcome
Timeframe: From initiation of therapy until documented disease progression or initiation of new therapy. Maximum treatment durations for Arm A and Arm B were 68.4 and 59.0 weeks, respectively.Population: Full Analysis set: 14 participants randomized to Arm A and 13 participants randomized to Arm B.
To assess progression free survival (PFS)
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
PFS
|
5.21 months
Interval 2.73 to
Overall, 19 (70.4%) patients experienced progression during the study and 8 (29.6%) were censored, due to lack of PD assessments or deaths at the time of study termination.
|
2.89 months
Interval 1.51 to 4.6
|
3.73 months
Interval 2.73 to 5.78
|
SECONDARY outcome
Timeframe: Median treatment durations for Arm A and Arm B were 29.14 and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.To assess safety and general tolerability of melflufen by collecting non-serious Adverse Events (AEs) from the start of study treatment until 30 days after the last dose of any study drug (melflufen or dexamethasone) or initiation of subsequent therapy whichever occurred first. Serious AEs (SAEs) were collected from the time the subject signed the ICF until 30 days after the last dose of any study drug (melflufen or dexamethasone) or initiation of subsequent therapy whichever occurred first.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Back pain
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Blood and lymphatic system disorders
|
12 Participants
|
10 Participants
|
22 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Thrombocytopenia
|
8 Participants
|
10 Participants
|
18 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Neutropenia
|
8 Participants
|
7 Participants
|
15 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Anaemia
|
5 Participants
|
3 Participants
|
8 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Leukopenia
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Lymphopenia
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Febrile neutropenia
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Infections and infestations
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Pneumonia
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
COVID-19 pneumonia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Sepsis
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
General disorders and administration site conditions
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
General physical health deterioration
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Asthenia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Injury, poisoning and procedural complications
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Femur fracture
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Femoral neck fracture
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Gastrointestinal disorders
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Stomatitis
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Musculoskeletal and connective tissue disorders
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Musculoskeletal chest pain
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Nervous system disorders
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Ischaemic stroke
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Vascular disorders
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 3/4 Treatment-Emergent Adverse Events (TEAEs)
Hypertension
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From signing of the ICF until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever comes first. Median treatment durations for Arms A and B were 29.14 weeks and 12.14 weeks. AE reporting period=30 days longerTo assess safety and general tolerability of melflufen by collecting serious adverse events (SAEs) from the signing of the ICF until 30 days after the last dose of any study drug (melflufen or dexamethasone) or initiation of subsequent therapy whichever comes first.
Outcome measures
| Measure |
Peripheral Venous Catheter (PVC)
n=14 Participants
Combined treatment ARM for all PVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Central Venous Catheter (CVC)
n=13 Participants
Combined treatment ARM for all CVC administration from both ARM A \& ARM B during Cycle 1 and 2. Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). ARM A Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC. ARM B Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC. Melflufen: Peripheral versus central administration. Dexamethasone: Oral tablets.
|
Overall
n=27 Participants
Arm A plus Arm B
|
|---|---|---|---|
|
Grade 5 Treatment-Emergent Adverse Events (TEAEs)
General disorders and administration site conditions
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Grade 5 Treatment-Emergent Adverse Events (TEAEs)
Infections and infestations
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Grade 5 Treatment-Emergent Adverse Events (TEAEs)
Pneumonia
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 5 Treatment-Emergent Adverse Events (TEAEs)
COVID-19 pneumonia
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Grade 5 Treatment-Emergent Adverse Events (TEAEs)
General physical health deterioration
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Grade 5 Treatment-Emergent Adverse Events (TEAEs)
Death
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Grade 5 Treatment-Emergent Adverse Events (TEAEs)
Gastrointestinal disorders
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Grade 5 Treatment-Emergent Adverse Events (TEAEs)
Ileus
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Arm A
Serious events: 5 serious events
Other events: 13 other events
Deaths: 1 deaths
Arm B
Serious events: 9 serious events
Other events: 13 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm A
n=14 participants at risk
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
Arm B
n=13 participants at risk
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Gastrointestinal disorders
Ileus
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
General disorders
Death
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
General disorders
General physical health deterioration
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
15.4%
2/13 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Asymptomatic COVID-19
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
23.1%
3/13 • Number of events 4 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Pneumonia
|
14.3%
2/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
15.4%
2/13 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Nervous system disorders
Ischaemic stroke
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
Other adverse events
| Measure |
Arm A
n=14 participants at risk
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a PVC and Cycle 2 and onwards melflufen administered via a CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
Arm B
n=13 participants at risk
Melflufen 40 mg iv Day 1 of each 28-day cycle. Dexamethasone 40 mg po Days 1,8,15 and 22 of each 28-day cycle (20 mg for patients 75 years or older). Cycle 1 administered via a CVC and Cycle 2 administered via a PVC. From Cycle 3 and onwards melflufen administered via CVC.
Melflufen: Peripheral versus central administration
Dexamethasone: Oral tablets
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
64.3%
9/14 • Number of events 16 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
53.8%
7/13 • Number of events 12 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
2/14 • Number of events 7 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.1%
1/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 3 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Blood and lymphatic system disorders
Neutropenia
|
64.3%
9/14 • Number of events 36 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
69.2%
9/13 • Number of events 33 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
71.4%
10/14 • Number of events 34 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
76.9%
10/13 • Number of events 23 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
General disorders
Asthenia
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
General disorders
Fatigue
|
7.1%
1/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
15.4%
2/13 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
General disorders
General physical health deterioration
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
General disorders
Pyrexia
|
14.3%
2/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
23.1%
3/13 • Number of events 3 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
COVID-19
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Infection
|
7.1%
1/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Pharyngitis
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Respiratory tract infection
|
14.3%
2/14 • Number of events 3 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Rhinitis
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Investigations
Body temperature increased
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Investigations
C-reactive protein increased
|
14.3%
2/14 • Number of events 3 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Investigations
SARS-CoV-2 test positive
|
14.3%
2/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
30.8%
4/13 • Number of events 4 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
15.4%
2/13 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.3%
2/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
2/14 • Number of events 2 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
7.7%
1/13 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
|
Vascular disorders
Vascular pain
|
7.1%
1/14 • Number of events 1 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
0.00%
0/13 • SAEs were collected from signing of the ICF until 30 days after last dose of study treatment or initiation of subsequent therapy, whichever occurred first. Non-serious AEs were collected from the start of study treatment until 30 days after the last dose of any study drug or initiation of subsequent therapy, whichever occurred first. Median treatment durations for Arm A and Arm B were 29.14 weeks and 12.14 weeks, respectively. The AE reporting period is estimated to be 30 days longer.
Adverse events cannot be compared for Arm A versus Arm B. Because of the crossover design of the study, all patients had a different route of administration in Cycle 2 than Cycle 1, and later AEs could be due to a cumulative effect of multiple treatment cycles. Thus, AEs occurring in Cycle 2 and beyond cannot be attributed to only 1 route of administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place