Phase
Condition
Bone Neoplasm
Lymphoproliferative Disorders
Leukemia
Treatment
BMS-986158
Trametinib
Tazemetostat
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Relapsed or refractory multiple myeloma (MM) and must:
Have documented disease progression during or after their last myeloma therapy.
For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidatefor available, established therapies known to provide clinical benefit in MM;For Part 2 Dose Expansion: Be refractory to or have relapsed after at least 2prior lines of therapy that include an immunomodulatory drug (IMiD), aproteasome 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 isnot 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
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 clinicallysignificant light-chain amyloidosis.
Impaired cardiac function or clinically significant cardiac disease
Previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomaticinfections 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, ortrametinib
Previously received allogeneic stem-cell transplant at any time or receivedautologous stem-cell transplant within 12 weeks of initiating study treatment
Received any of the following within 14 days prior to initiating study treatment:
Plasmapheresis
Major surgery
Radiation therapy other than local therapy for myeloma associated bone lesions
Use of any systemic anti-myeloma drug therapy
Used any investigational agents within 28 days or 5 half-lives (whichever isshorter) prior to initiating study treatment
COVID-19 vaccine within 14 days prior to C1D1
Other protocol-defined inclusion/exclusion criteria apply
Study Design
Connect with a study center
Alberta Health Services AHS - Foothills Medical Centre FMC
Calgary, Alberta T2N 5G2
CanadaActive - Recruiting
Local Institution - 0009
Calgary, Alberta T2N 4N2
CanadaActive - Recruiting
Local Institution - 0008
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
University of Alberta - Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaActive - Recruiting
Local Institution - 0004
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
University Health Network UHN - Princess Margaret Hospital PMH
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Local Institution - 0012
Oslo, Outside US And Canada 0450
NorwayActive - Recruiting
Oslo University Hospital
Oslo, 0450
NorwayActive - Recruiting
ICO - Hospital Germans Trias i Pujol
Barcelona, 08026
SpainActive - Recruiting
Local Institution - 0011
Barcelona, 08026
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Local Institution - 0005
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39008
SpainActive - Recruiting
Local Institution - 0003
Santander, 39008
SpainActive - Recruiting
Local Institution - 0006
London, Greater London W1T 7HA
United KingdomActive - Recruiting
Local Institution - 0017
Manchester, Greater Manchester M20 4BX
United KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester, Greater Manchester M20 4BX
United KingdomActive - Recruiting
Leicester Royal Infirmary
Leicester, Leicestershire LE1 5WW
United KingdomSite Not Available
Local Institution - 0001
Leicester, Leicestershire LE1 5WW
United KingdomSite Not Available
Local Institution - 0014
Liverpool, Merseyside L7 8YA
United KingdomSite Not Available
Churchill Hospital
Oxford, Oxfordshire OX3 7LE
United KingdomActive - Recruiting
Local Institution - 0016
Oxford, Oxfordshire OX3 7LE
United KingdomSite Not Available
NIHR UCLH Clinical Research Facility
London, W1T 7HA
United KingdomActive - Recruiting
UAB Comprehensive Cancer Center
Birmingham, Alabama 35249
United StatesActive - Recruiting
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United StatesActive - Recruiting
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