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

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Status and phase

Active, not recruiting
Phase 1


Multiple Myeloma


Drug: CC-92328

Study type


Funder types



2020-005968-64 (EudraCT Number)

Details and patient eligibility


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).


70 estimated patients




18+ years old


No Healthy Volunteers

Inclusion criteria

Participants must satisfy the following criteria to be enrolled in the study:

  1. must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
  2. willing and able to adhere to the study visit schedule and other protocol requirements.
  3. Participant is ≥ 18 years of age the time of signing the ICF.
  4. Participant has a history of multiple myeloma (MM) with relapsed and/or refractory disease who have failed or who are ineligible or intolerant to available therapies that may provide clinical benefit.
  5. Have documented disease progression on or within 12 months from the last dose of their last myeloma therapy.
  6. Participant must have measurable disease.
  7. Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  8. Females of childbearing potential (FCBP) must commit to true abstinence from heterosexual contact or agree to use at least one method of highly effective contraception without interruption from screening to at least 12 weeks after the last dose of CC-92328
  9. Males must practice true abstinence or agree to use a condom
  10. FCBP and males must avoid conceiving from signing the ICF, while participating in the study, during dose interruptions, and for at least 12 weeks after the last dose of CC-92328.

Exclusion criteria

The presence of any of the following will exclude a participant from enrollment:

  1. Participant has symptomatic central nervous system involvement of MM.
  2. Participant had a prior autologous stem cell transplant ≤ 90 days prior to starting CC-92328.
  3. Participant had a prior allogeneic stem cell transplant with either standard or reduced intensity conditioning ≤ 12 months prior to starting CC-92328.
  4. Participant had prior systemic cancer-directed treatments or investigational modalities ≤ 5 half-lives or 4 weeks prior to starting CC-92328, whichever is shorter.
  5. Participant is a pregnant or lactating female.
  6. Participant received live virus vaccines within at least 4 weeks prior to starting study drug.
  7. Participant has known active human immunodeficiency virus (HIV) infection.
  8. Participant has active hepatitis B or C (HBV/HCV) infection.
  9. Participant weight is ≤ 40 kg at screening.

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

70 participants in 1 patient group

Administration of CC-92328
Experimental group
CC-92328 administered intravenously in 28-day cycles
Drug: CC-92328

Trial contacts and locations



Central trial contact

BMS Study Connect Contact Center; First line of the email MUST contain NCT # and Site #.

Data sourced from

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