Trial Outcomes & Findings for E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma (NCT NCT02279394)
NCT ID: NCT02279394
Last Updated: 2023-06-09
Results Overview
Percent of patients who are alive and without documented progression after at least 2-years of follow-up. All patients who receive study treatment are assessed including those who have died or lost to follow-up prior to 2-years. Progression was defined as an increase in SPEP \[25% and an absolute increase of 0.5g/d\] or UPEP \[25% and an absolute increase of 200mg/24hours\] on 2 successive evaluations as determined by the IMWG response criteria or documented progression by the FreeLite progressive disease criteria in the absence of serum or urine involvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
2 Years
Results posted on
2023-06-09
Participant Flow
Participant milestones
| Measure |
Elo / Len / Dex
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
Other Name: Decadron
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
|
Elo / Len
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
11
|
|
Overall Study
COMPLETED
|
40
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Elo / Len / Dex
n=40 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
Other Name: Decadron
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
|
Elo / Len
n=11 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Age, Continuous
|
62 years
n=93 Participants
|
62 years
n=4 Participants
|
62 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=93 Participants
|
11 participants
n=4 Participants
|
51 participants
n=27 Participants
|
|
ECOG Performance Status
00 - Fully Active
|
27 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
ECOG Performance Status
01 - Restricted
|
12 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
ECOG Performance Status
02 - Ambulatory
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 2 YearsPercent of patients who are alive and without documented progression after at least 2-years of follow-up. All patients who receive study treatment are assessed including those who have died or lost to follow-up prior to 2-years. Progression was defined as an increase in SPEP \[25% and an absolute increase of 0.5g/d\] or UPEP \[25% and an absolute increase of 200mg/24hours\] on 2 successive evaluations as determined by the IMWG response criteria or documented progression by the FreeLite progressive disease criteria in the absence of serum or urine involvement.
Outcome measures
| Measure |
Elo / Len / Dex
n=40 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
Other Name: Decadron
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
|
Elo / Len
n=11 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
|
|---|---|---|
|
Percent of Patients Who Are Progression Free at 2 Years
|
45.0 percentage of participants
Interval 31.5 to 59.1
|
36.4 percentage of participants
Interval 13.6 to 65.0
|
SECONDARY outcome
Timeframe: 2 Years from start of treatmentPercent of patients with objective response defined as partial response or better based on the International Myeloma Working Group Response (IMWG) criteria
Outcome measures
| Measure |
Elo / Len / Dex
n=40 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
Other Name: Decadron
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
|
Elo / Len
n=11 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
|
|---|---|---|
|
Objective Response Percent
|
82.5 percentage of participants
Interval 69.6 to 91.5
|
72.7 percentage of participants
Interval 43.6 to 92.1
|
SECONDARY outcome
Timeframe: From start of treatment up to +/- 60 monthsTime from initiation of therapy to progression defined by the IMWG criteria.
Outcome measures
| Measure |
Elo / Len / Dex
n=40 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
Other Name: Decadron
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
|
Elo / Len
n=11 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
|
|---|---|---|
|
Time to Progression
|
56.1 months
Interval 9.3 to 61.4
|
56.2 months
Interval 27.9 to 62.5
|
SECONDARY outcome
Timeframe: From start of treatment up to +/- 60 monthsTime from initiation of therapy to death
Outcome measures
| Measure |
Elo / Len / Dex
n=40 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
Other Name: Decadron
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
|
Elo / Len
n=11 Participants
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
|
|---|---|---|
|
Overall Survival
|
50.5 months
Interval 11.3 to 61.4
|
60.2 months
Interval 39.1 to 66.0
|
Adverse Events
Elo / Len / Dex
Serious events: 8 serious events
Other events: 40 other events
Deaths: 2 deaths
Elo / Len
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Elo / Len / Dex
n=40 participants at risk
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
Other Name: Decadron
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
|
Elo / Len
n=11 participants at risk
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.5%
3/40 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/40 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Eye disorders
Cataract
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Lymphocyte count increased
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
General disorders
Myocardial infarction
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Infections and infestations
Sepsis
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Hypophosphatemia
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
Other adverse events
| Measure |
Elo / Len / Dex
n=40 participants at risk
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
•Drug: Dexamethasone 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
Other Name: Decadron
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
Dexamethasone: 40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
|
Elo / Len
n=11 participants at risk
•Drug: Elotuzumab 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Other Name: HuLuc63
•Drug: Lenalidomide 25 mg Oral; Days 1-21 days Cycles 1-24
Other Name: REVLIMID
Elotuzumab: 10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 \& 15 Cycles 3-8
Lenalidomide: 25 mg Oral; Days 1-21 days Cycles 1-24
|
|---|---|---|
|
General disorders
Fatigue
|
90.0%
36/40 • Number of events 72 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
100.0%
11/11 • Number of events 47 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
32/40 • Number of events 70 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
54.5%
6/11 • Number of events 24 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
57.5%
23/40 • Number of events 82 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
81.8%
9/11 • Number of events 43 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
White blood cell decreased
|
55.0%
22/40 • Number of events 97 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
45.5%
5/11 • Number of events 11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Psychiatric disorders
Insomnia
|
52.5%
21/40 • Number of events 28 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
45.5%
5/11 • Number of events 7 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
20/40 • Number of events 29 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
45.5%
5/11 • Number of events 17 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Blood and lymphatic system disorders
Anemia
|
42.5%
17/40 • Number of events 48 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
54.5%
6/11 • Number of events 13 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
45.0%
18/40 • Number of events 78 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
72.7%
8/11 • Number of events 26 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Infections and infestations
Upper respiratory infection
|
45.0%
18/40 • Number of events 33 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
45.5%
5/11 • Number of events 11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
16/40 • Number of events 29 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
54.5%
6/11 • Number of events 16 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Neutrophil count decreased
|
47.5%
19/40 • Number of events 131 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
36.4%
4/11 • Number of events 28 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Platelet count decreased
|
42.5%
17/40 • Number of events 71 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 16 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
10/40 • Number of events 25 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
63.6%
7/11 • Number of events 20 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
32.5%
13/40 • Number of events 28 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 16 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
10/40 • Number of events 31 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
45.5%
5/11 • Number of events 23 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
30.0%
12/40 • Number of events 17 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 6 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Lymphocyte count decreased
|
30.0%
12/40 • Number of events 76 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 22 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
8/40 • Number of events 22 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
36.4%
4/11 • Number of events 14 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
8/40 • Number of events 14 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 5 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Psychiatric disorders
Anxiety
|
17.5%
7/40 • Number of events 7 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.5%
9/40 • Number of events 19 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 5 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
8/40 • Number of events 9 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
8/40 • Number of events 8 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
General disorders
Edema limbs
|
15.0%
6/40 • Number of events 9 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Nervous system disorders
Headache
|
17.5%
7/40 • Number of events 10 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 8 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Vascular disorders
Hypertension
|
20.0%
8/40 • Number of events 17 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
22.5%
9/40 • Number of events 14 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
6/40 • Number of events 9 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 5 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
6/40 • Number of events 10 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Nervous system disorders
Dizziness
|
15.0%
6/40 • Number of events 11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Nervous system disorders
Dysgeusia
|
17.5%
7/40 • Number of events 7 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
General disorders
Fever
|
17.5%
7/40 • Number of events 11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Infections and infestations
Lung infection
|
20.0%
8/40 • Number of events 9 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
17.5%
7/40 • Number of events 7 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
6/40 • Number of events 6 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
6/40 • Number of events 7 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
7.5%
3/40 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
36.4%
4/11 • Number of events 5 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Psychiatric disorders
Depression
|
12.5%
5/40 • Number of events 5 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Infections and infestations
Infections and infestations - Other
|
12.5%
5/40 • Number of events 6 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
General disorders
Infusion related reaction
|
10.0%
4/40 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.5%
3/40 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 5 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Infections and infestations
Sinusitis
|
12.5%
5/40 • Number of events 7 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
4/40 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Psychiatric disorders
Agitation
|
10.0%
4/40 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Alkaline phosphatase increased
|
7.5%
3/40 • Number of events 6 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
5/40 • Number of events 6 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
4/40 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
General disorders
Flu like symptoms
|
12.5%
5/40 • Number of events 6 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Vascular disorders
Hypotension
|
12.5%
5/40 • Number of events 7 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
5.0%
2/40 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 7 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
5/40 • Number of events 5 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Skin and subcutaneous tissue disorders
Skin/subcutaneous tissue disorders; Other
|
5.0%
2/40 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Vascular disorders
Thromboembolic event
|
10.0%
4/40 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Metabolism and nutrition disorders
Anorexia
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
27.3%
3/11 • Number of events 7 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Eye disorders
Blurred vision
|
10.0%
4/40 • Number of events 5 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.0%
4/40 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.5%
3/40 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
4/40 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
0.00%
0/11 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Investigations
Weight gain
|
7.5%
3/40 • Number of events 4 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Bloating
|
5.0%
2/40 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.5%
1/40 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 3 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
General disorders
Pain
|
5.0%
2/40 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
9.1%
1/11 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
|
Cardiac disorders
Palpitations
|
2.5%
1/40 • Number of events 1 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
18.2%
2/11 • Number of events 2 • Adverse Events assessed/monitored from the day of consent up to the end of treatment for an average of 26 months All-Cause Mortality as well as Serious Adverse Events were collected up to +/- 60 months. These duration may vary individually based on possible dose delays as well as follow up study visit delays or some participants possibly coming off study early.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place