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A Phase 1, Multi-Center, Open-Label, Dose Finding Study Of CC-92328 In Subjects With Relapsed and/or Refractory Multiple Myeloma

Protocol No
CELGENE-CC-92328-MM-001
Principal Investigator
Binod Dhakal
Phase
I
Summary
Study CC-92328-MM-001 is a multicenter, open-label, two-part, first-in-human (FIH), Phase 1, dose finding study to determine the safety, tolerability, PK, and pharmacodynamics (PD) of CC-92328 in subjects with R/R MM. The study will start with a dose escalation phase (Part A), guided by a hybrid of a modified accelerated titration design and the two-parameter Bayesian logistic regression model (BLRM), to determine the MTD, and/or RP2D of CC-92328.
Description
To determine the safety and tolerability of CC-92328 in subjects with R/R MM. To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-92328 in subjects with R/R MM.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL