A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

Description

The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).

Conditions

Multiple Myeloma

Study Overview

Study Details

Study overview

The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).

An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants With Relapsed or Refractory Multiple Myeloma

A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Birmingham

UAB Comprehensive Cancer Center, Birmingham, Alabama, United States, 35249

Baltimore

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States, 21287

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Hackensack

John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States, 07601

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Relapsed or refractory multiple myeloma (MM) and must:
  • 1. have documented disease progression during or after their last myeloma therapy
  • 2. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM
  • * Must have measurable disease
  • * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  • * Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)
  • * Known active or history of central nervous system (CNS) involvement of MM
  • * Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis.
  • * Impaired cardiac function or clinically significant cardiac disease
  • * Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1)
  • * For Part 1: received prior therapy with CC-92480
  • * For Part 2: received prior therapy with CC-92480, tazemetostat, BMS-986158, or trametinib
  • * Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment
  • * Received any of the following within 14 days prior to initiating study treatment:
  • 1. Plasmapheresis
  • 2. Major surgery
  • 3. Radiation therapy other than local therapy for myeloma associated bone lesions
  • 4. Use of any systemic anti-myeloma drug therapy
  • * Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment
  • * COVID-19 vaccine within 14 days prior to C1D1

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2026-10-12