Phase 2
Completed N=117
An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Source: ClinicalTrials.gov NCT02654132 ↗Enrolled (actual)
117
Serious AEs
65.2%
Results posted
Jun 2019
Primary outcomePrimary: Progression Free Survival (PFS) — 10.25; 4.70 Months — p=0.0043
Summary
The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
10.25; 4.70 | 0.0043 sig |
| SECONDARY Objective Response Rate (ORR) |
58.3; 24.6 | 0.0002 sig |
| SECONDARY Overall Survival (OS) |
29.80; 17.41 | 0.0217 sig |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination
- Documented refractory or relapsed and refractory multiple myeloma
- Refractory to proteosome inhibitor and lenalidomide, and to last treatment
- Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment
- Measurable disease at screening
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion Criteria
- Active plasma cell leukemia
- Prior treatment with pomalidomide
- Unable to tolerate thromboembolic prophylaxis while on the study
- Prior autologous stem cell transplant within 12 weeks
- Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Data sourced from ClinicalTrials.gov (NCT02654132). 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.