Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma

Official Title

A Phase 1, Multi-centre, Open-label, Dose Finding Study of CC-92328 in Subjects With Relapsed and/or Refractory Multiple Myeloma


This Phase 1, first-in-human (FIH), clinical study of CC-92328 will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). The study will be conducted in two parts: monotherapy dose escalation (Part A) and monotherapy dose expansion (Part B).

Trial Description

Primary Outcome:

  • Dose-Limiting Toxicities (DLTs)
  • Maximum Tolerated Dose (MTD)
  • Incidence of Adverse Events (AEs)
Secondary Outcome:
  • Preliminary Efficacy - Overall Response Rate (ORR)
  • Preliminary Efficacy - Time to response
  • Preliminary Efficacy - Duration of response
  • Preliminary Efficacy - Progression-free Survival (PFS)
  • Preliminary Efficacy - Overall Survival (OS)
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - Cmin
  • Pharmacokinetics - AUC
  • Pharmacokinetics - tmax
  • Pharmacokinetics - t1/2
  • Pharmacokinetics - CL
  • Pharmacokinetics - Vd
  • Pharmacokinetics - Accumulation index of CC-92328
  • Presence of Anti-CC92328 antibodies (ADA)
  • Frequency of Anti-CC92328 antibodies (ADA)

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society