Phase 3
Completed N=646
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Source: ClinicalTrials.gov NCT01239797 ↗Enrolled (actual)
646
Serious AEs
68.0%
Results posted
Jan 2017
Primary outcomePrimary: Median Progression Free Survival (PFS) — 19.35; 14.85 Months — p=0.0014
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Progression Free Survival (PFS) |
19.35; 14.85 | 0.0014 sig |
| PRIMARY Objective Response Rate (ORR) |
78.5; 65.5 | 0.0002 sig |
| SECONDARY Median Overall Survival (OS) |
48.30; 39.62 | — |
| SECONDARY Change From Baseline of Mean Score Pain Severity (BPI-SF) |
0.52; -0.04 | — |
| SECONDARY Change From Baseline of Mean Score Pain Interference (BPI-SF) |
0.95; 0.48 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
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
Data sourced from ClinicalTrials.gov (NCT01239797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.