Description:
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.
Title
- Brief Title: Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
- Official Title: A Randomized Parallel Phase 2 Study of Elotuzumab Plus Lenalidomide (Elo/Rev) for the Treatment of Serologic Relapse/Progression While on Lenalidomide Maintenance for Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
MCC-19197
- SECONDARY ID:
NCI-2018-00891
- NCT ID:
NCT03411031
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Elotuzumab | Empliciti™, BMS-901608, HuLuc63 | A: Elotuzumab + Lenalidomide at 25 mg |
Lenalidomide | REVLIMID®, thalidomide analogue | A: Elotuzumab + Lenalidomide at 25 mg |
Dexamethasone | Decadron | A: Elotuzumab + Lenalidomide at 25 mg |
Purpose
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.
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
A: Elotuzumab + Lenalidomide at 25 mg | Active Comparator | 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
- Lenalidomide
- Dexamethasone
|
B: Elotuzumab + Lenalidomide at 10 mg | Active Comparator | 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
- Lenalidomide
- Dexamethasone
|
Eligibility Criteria
Inclusion Criteria:
- Patients with multiple myeloma who demonstrate evidence of serologic
relapse/progression while on lenalidomide maintenance given as part of first line
therapy (including upfront high-dose chemotherapy followed by autologous hematopoietic
cell transplantation (HCT)) without symptomatic relapse/progression. Lenalidomide
maintenance is defined as single agent lenalidomide therapy of any doses up to 10 mg
PO daily for up to 28 days (28-day cycle).
- Male or female patients aged ≥ 18 years old
- Ability to provide written informed consent obtained prior to participation in the
study and any related procedures being performed
- Measurable disease as outlined in protocol guidelines
- Participants must meet laboratory criteria as outlined in protocol guidelines
Exclusion Criteria:
- Prior Elotuzumab
- 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:
- Development of new soft tissue plasmacytomas or bone lesions (osteoporotic
fractures do not constitute progression)
- Definite increase in the size of existing plasmacytomas or bone lesions. A
definite increase is defined as a 50% (and ≥1 cm) increase as measured serially
of the measurable lesion
- Hypercalcemia (>11 mg/dL);
- Decrease in hemoglobin of ≥2 g/dL not related to therapy or other
non-myeloma-related conditions;
- Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and
attributable to myeloma
- Hyperviscosity related to serum paraprotein
- Women who are pregnant or breast feeding or women of childbearing potential (WOCBP)
not using an effective method of birth control. Women of childbearing potential must
have a negative serum pregnancy testing within 7 days prior to the administration of
drug.
- Male patients whose sexual partners are WOCBP not using effective birth control
- Patients with a prior malignancy with in the last 5 years (except for basal or
squamous cell carcinoma, or in situ cancer of the cervix)
- Patients with known positivity for human immunodeficiency virus (HIV)) or hepatitis C;
baseline testing for HIV and hepatitis C is not required
- Patients with a diagnosis of POEMS syndrome (polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, and skin changes) or plasma cell leukemia (> 2.0 ×
10^9/L circulating plasma cells by standard differential)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival (PFS) |
Time Frame: | 12 months post last participant enrollment date |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Overall Response Rate (ORR) |
Time Frame: | Up to 60 days post last study treatment |
Safety Issue: | |
Description: | Overall response rate (ORR) 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. |
Measure: | Minimum Response (MR) |
Time Frame: | Up to 60 days post last study treatment |
Safety Issue: | |
Description: | Minimum response (MR) or better rate 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. |
Measure: | Time to Next Treatment (TTNT) |
Time Frame: | Up to 60 days post last study treatment |
Safety Issue: | |
Description: | Time to next treatment (TTNT): Median time free of treatment per study arm. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
Trial Keywords
- lenalidomide maintenance
- hematopoietic cell transplantation
- serologic relapse
Last Updated
June 14, 2021