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NCT05372354PHASE1, PHASE2Recruiting

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

Bristol-Myers Squibb

Start Date

10/18/2022

Completion Date

10/12/2026

Summary

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).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Relapsed or refractory multiple myeloma (MM) and must: 1. Have documented disease progression during or after their last myeloma therapy. 2. For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after the protocol specified number of prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant is not a candidate for TRT. * 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). Exclusion Criteria: * 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 Other protocol-defined inclusion/exclusion criteria apply

Interventions

DRUG

CC-92480

DRUG

Tazemetostat

DRUG

BMS-986158

DRUG

Trametinib

DRUG

Dexamethasone

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Conditions

Multiple Myeloma

Locations

UAB Comprehensive Cancer Center

Birmingham, Alabama 35249

United States

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland 21287

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey 07601

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

Alberta Health Services AHS - Foothills Medical Centre FMC

Calgary, Alberta T2N 5G2

Canada

University of Alberta - Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

University Health Network UHN - Princess Margaret Hospital PMH

Toronto, Ontario M5G 2M9

Canada

Oslo University Hospital

Oslo, Outside US and Canada 0450

Norway

ICO - Hospital Germans Trias i Pujol

Barcelona, 08026

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Universitario Marques de Valdecilla

Santander, 39008

Spain

The Christie NHS Foundation Trust

Manchester, Greater Manchester M20 4BX

United Kingdom

Local Institution - 0001

Leicester, Leicestershire LE1 5WW

United Kingdom

Local Institution - 0014

Liverpool, Merseyside L7 8YA

United Kingdom

Churchill Hospital

Oxford, Oxfordshire OX3 7LE

United Kingdom

NIHR UCLH Clinical Research Facility

London, W1T 7HA

United Kingdom