A Phase 2 interventional study of Elotuzumab and Lenalidomide in Multiple Myeloma, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment
The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.
This is a randomized parallel 2-cohort phase 2 study of elotuzumab given at 10 mg/kg weekly during induction in combination with lenalidomide (either 25 mg or 10 mg) in patients with multiple myeloma who progress or relapse serologically while on single agent lenalidomide maintenance.
The combination therapy with elotuzumab and lenalidomide will be continued until further progression of myeloma (based on response criteria) or intolerability.
Exclusion Criteria:
Patients with clinical relapse/progression as per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma defined as one or more of the following criteria:
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.
Drug: Elotuzumab · Drug: Lenalidomide · Drug: Dexamethasone
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.
Drug: Elotuzumab · Drug: Lenalidomide · Drug: Dexamethasone
Elotuzumab according to dosing schedule outlined in treatment arms.
Also known as: Empliciti™, BMS-901608, HuLuc63
Lenalidomide according to dosing schedule outlined in treatment arms.
Also known as: REVLIMID®, thalidomide analogue
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.
Also known as: Decadron
Percentage of Participants With Progression Free Survival (PFS)
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.
Time frame: An average of 8 months
Overall Response
Overall 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;
Time frame: Up to 60 days post last study treatment
Minimum Response (MR)
Minimum 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.
Time frame: Up to 60 days post last study treatment
| Milestone | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg |
|---|---|---|
| Started | 9 | 9 |
| Completed | 9 | 9 |
| Not completed | 0 | 0 |
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.
| percentage of participants | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg |
|---|---|---|
| Percentage of Participants With Progression Free Survival (PFS) | 11.1 (0.1 to 38.8) | 22.2 (3.4 to 51.3) |
Overall 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;
| Participants | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg |
|---|---|---|
| Overall Response | 1 | 2 |
Minimum 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.
| Participants | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg |
|---|---|---|
| Minimum Response (MR) | 2 | 3 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A: Elotuzumab + Lenalidomide at 25 mg | 0/9 (0%) | 3/9 (33.3%) | 2/9 (22.2%) |
| B: Elotuzumab + Lenalidomide at 10 mg | 0/9 (0%) | 0/9 (0%) | 1/9 (11.1%) |
| Event | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg |
|---|---|---|
| FeverGeneral disorders | 1/9 | 0/9 |
| Non-cardiac chest painCardiac disorders | 1/9 | 0/9 |
| Lung Infection - Probable PneumoniaInfections and infestations | 1/9 | 0/9 |
| Lung InfectionInfections and infestations | 1/9 | 0/9 |
| Event | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg |
|---|---|---|
| FatigueGeneral disorders | 1/9 | 0/9 |
| Neutrophil count decreasedInvestigations | 0/9 | 1/9 |
| SyncopeNervous system disorders | 1/9 | 0/9 |
| Age, Categorical(Participants) | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 4 | 11 |
| >=65 years | 2 | 5 | 7 |
| Sex: Female, Male(Participants) | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 6 | 5 | 11 |
| Ethnicity (NIH/OMB)(Participants) | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 9 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 6 | 7 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | A: Elotuzumab + Lenalidomide at 25 mg | B: Elotuzumab + Lenalidomide at 10 mg | Total |
|---|---|---|---|
| United States | 9 | 9 | 18 |
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H. Lee Moffitt Cancer Center and Research Institute