CPD-DARA in Patients With Relapsed/Refractory Multiple Myeloma.
Status:
Not yet recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
This study is a Phase Ib, open label, single arm, adaptive multi-centre clinical study. The
target population for this study are patients with relapsed/refractory multiple myeloma (MM).
Patients will have a confirmed diagnosis of MM, with measurable disease as per IMWG criteria,
in the second relapse and beyond (third line of therapy and beyond). Patients will need to
have exposure to lenalidomide and a proteasome inhibitor. Patients will be treated with
Cyclophosphamide-Pomalidomide-Dexamethasone (CPD) in combination with daratumumab (DARA) to
determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended
Phase II Dose (RP2D) of the combination.
Pomalidomide will be administered orally at three dose levels 4, 3 and 2mg on days 1-21 of
each 28-day cycle. Treatment will be repeated on day 1 of a 28-day cycle until disease
progression, unacceptable toxicity, withdrawal of consent, physician's decision, or sponsor's
decision to terminate the study, whichever occurs first.