Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-jRCT2080223190
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Elotuzumab added to the Pd regimen improved PFS and ORR without increase in toxicity. This is the first randomized, active controlled study to demonstrate the efficacy and overall risk/benefit of a novel triplet regimen (E-Pd) based on pomalidomide-dexamethasone backbone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 117
At least 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 less than or equal to 2
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Progression-free survival (PFS)<br>PFS will be defined as the time, in months, from randomization to the date of the first documented tumor progression or death due to any cause
- Secondary Outcome Measures
Name Time Method efficacy<br>Objective Response Rate (ORR)<br>Overall Survival (OS)<br>-