At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Measurable multiple myeloma disease by serum M-protein, urine M-protein, or free light chain criteria
- ✓Prior treatment with both a proteasome inhibitor and lenalidomide
- ✓Demonstrated prior response (PR or better) to previous therapy
- ✕Prior anti-CD38 monoclonal antibody therapy
- ✕Prior pomalidomide exposure
- ✕Antimyeloma treatment within 2 weeks or 5 half-lives before randomization (exception: short-course corticosteroids for palliation)
- ✕Prior allogeneic stem cell transplant or autologous transplant within 12 weeks before first dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With RRMM Who Have Received at Least One Prior Line of Therapy With Both Lenalidomide and a Proteasome Inhibitor.
In Brief
A Phase 3 clinical trial evaluating Daratumumab, Pomalidomide, and 1 other intervention for Multiple Myeloma. Completed, enrolled 304 participants across 40 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate the effects of the addition of daratumumab to pomalidomide and dexamethasone in terms of progression-free survival in subjects with relapsed or refractory Multiple Myeloma.
Study Details
Timeline
Interventions
Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs.
Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.
Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.