Trial Outcomes & Findings for Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide (NCT NCT03411031)
NCT ID: NCT03411031
Last Updated: 2023-03-29
Results Overview
Progression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
An average of 8 months
Results posted on
2023-03-29
Participant Flow
Participant milestones
| Measure |
A: Elotuzumab + Lenalidomide at 25 mg
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
B: Elotuzumab + Lenalidomide at 10 mg
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
Baseline characteristics by cohort
| Measure |
A: Elotuzumab + Lenalidomide at 25 mg
n=9 Participants
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
B: Elotuzumab + Lenalidomide at 10 mg
n=9 Participants
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: An average of 8 monthsProgression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval.
Outcome measures
| Measure |
A: Elotuzumab + Lenalidomide at 25 mg
n=9 Participants
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
B: Elotuzumab + Lenalidomide at 10 mg
n=9 Participants
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
|---|---|---|
|
Percentage of Participants With Progression Free Survival (PFS)
|
11.1 percentage of participants
Interval 0.1 to 38.8
|
22.2 percentage of participants
Interval 3.4 to 51.3
|
SECONDARY outcome
Timeframe: Up to 60 days post last study treatmentOverall response with elotuzumab and lenalidomide for each study arm. Overall Response is defined as best Overall Response, as Complete Response or Partial Response. Response will be assessed per the uniform response criteria of the International Myeloma Working Group(IMWG). Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle. Complete Response= Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates; Partial Response= ≥50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by ≥90% or to \<200 mg per 24 h;
Outcome measures
| Measure |
A: Elotuzumab + Lenalidomide at 25 mg
n=9 Participants
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
B: Elotuzumab + Lenalidomide at 10 mg
n=9 Participants
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
|---|---|---|
|
Overall Response
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 60 days post last study treatmentMinimum response (MR) or better with elotuzumab and lenalidomide for each study arm. The Consensus on Uniform Reporting of Response will be used to evaluate response. Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle.
Outcome measures
| Measure |
A: Elotuzumab + Lenalidomide at 25 mg
n=9 Participants
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
B: Elotuzumab + Lenalidomide at 10 mg
n=9 Participants
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
|---|---|---|
|
Minimum Response (MR)
|
2 Participants
|
3 Participants
|
Adverse Events
A: Elotuzumab + Lenalidomide at 25 mg
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
B: Elotuzumab + Lenalidomide at 10 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: Elotuzumab + Lenalidomide at 25 mg
n=9 participants at risk
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
B: Elotuzumab + Lenalidomide at 10 mg
n=9 participants at risk
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
|---|---|---|
|
General disorders
Fever
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
0.00%
0/9 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
|
Cardiac disorders
Non-cardiac chest pain
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
0.00%
0/9 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
|
Infections and infestations
Lung Infection - Probable Pneumonia
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
0.00%
0/9 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
|
Infections and infestations
Lung Infection
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
0.00%
0/9 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
Other adverse events
| Measure |
A: Elotuzumab + Lenalidomide at 25 mg
n=9 participants at risk
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
B: Elotuzumab + Lenalidomide at 10 mg
n=9 participants at risk
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
Elotuzumab: Elotuzumab according to dosing schedule outlined in treatment arms.
Lenalidomide: Lenalidomide according to dosing schedule outlined in treatment arms.
Dexamethasone: Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
|
|---|---|---|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 2 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
0.00%
0/9 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
|
Nervous system disorders
Syncope
|
11.1%
1/9 • Number of events 1 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
0.00%
0/9 • Adverse events were collected from cycle 1, day 1, and only while the participants were on study treatment only for up to a total of 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place