Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 646
- Locations
- 39
- Primary Endpoint
- Median Progression Free Survival (PFS)
Overview
Brief Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Documented progression from most recent line of therapy
- •1-3 prior lines of therapy
- •Measurable disease
- •Life expectancy ≥3 months
- •Prior treatment with Lenalidomide permitted if:
- •Best response achieved was ≥Partial Response (PR)
- •Patient was not refractory
- •Patient did not discontinue due to a Grade ≥3 related adverse event
- •Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression
Exclusion Criteria
- •Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
- •Active plasma cell leukemia
- •Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
Arms & Interventions
Lenalidomide + Dexamethasone
Intervention: Lenalidomide (Drug)
Lenalidomide + Dexamethasone
Intervention: Dexamethasone (Drug)
Lenalidomide + Dexamethasone +Elotuzumab
Intervention: Lenalidomide (Drug)
Lenalidomide + Dexamethasone +Elotuzumab
Intervention: Dexamethasone (Oral) (Drug)
Lenalidomide + Dexamethasone +Elotuzumab
Intervention: Dexamethasone (IV) (Drug)
Lenalidomide + Dexamethasone +Elotuzumab
Intervention: Elotuzumab (BMS-901608; HuLuc63) (Biological)
Outcomes
Primary Outcomes
Median Progression Free Survival (PFS)
Time Frame: From randomization up to 326 events (up to approximately 38 months)
Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
Objective Response Rate (ORR)
Time Frame: From randomization up to approximately 38 months
Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR \[sCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
Secondary Outcomes
- Change From Baseline of Mean Score Pain Severity (BPI-SF)(From baseline up to approximately 38 months)
- Change From Baseline of Mean Score Pain Interference (BPI-SF)(From baseline up to approximately 38 months)
- Median Overall Survival (OS)(Randomization to the date of death from any cause (up to approximately 9 years))