Phase
Condition
Multiple Myeloma
Platelet Disorders
Lymphoproliferative Disorders
Treatment
Dexamethasone
CC-92480
BMS-986158
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 the protocolspecified number of prior lines of therapy that include an immunomodulatorydrug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirectingtherapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless theparticipant 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
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
CanadaSite Not Available
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
CanadaSite Not Available
Alberta Health Services AHS - Foothills Medical Centre FMC
Calgary 5913490, Alberta 5883102 T2N 5G2
CanadaActive - Recruiting
University of Alberta - Cross Cancer Institute
Edmonton 5946768, Alberta 5883102 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
CanadaSite Not Available
University Health Network UHN - Princess Margaret Hospital PMH
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaActive - Recruiting
Local Institution - 0012
Oslo, Outside US And Canada 0450
NorwayActive - Recruiting
Oslo University Hospital
Oslo 3143244, Outside US and Canada 0450
NorwayActive - Recruiting
Oslo University Hospital
Oslo, 0450
NorwaySite Not Available
ICO - Hospital Germans Trias i Pujol
Barcelona, 08026
SpainSite Not Available
Local Institution - 0011
Barcelona, 08026
SpainActive - Recruiting
ICO - Hospital Germans Trias i Pujol
Barcelona 3128760, 08026
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Local Institution - 0005
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid 3117735, 28041
SpainActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39008
SpainSite Not Available
Local Institution - 0003
Santander, 39008
SpainActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander 3109718, 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 KingdomSite Not Available
The Christie NHS Foundation Trust
Manchester 2643123, 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 - 0001
Leicester 2644668, Leicestershire LE1 5WW
United KingdomSite Not Available
Local Institution - 0014
Liverpool, Merseyside L7 8YA
United KingdomSite Not Available
Local Institution - 0014
Liverpool 2644210, Merseyside L7 8YA
United KingdomSite Not Available
Churchill Hospital
Oxford, Oxfordshire OX3 7LE
United KingdomSite Not Available
Local Institution - 0016
Oxford, Oxfordshire OX3 7LE
United KingdomSite Not Available
Churchill Hospital
Oxford 2640729, Oxfordshire OX3 7LE
United KingdomActive - Recruiting
NIHR UCLH Clinical Research Facility
London, W1T 7HA
United KingdomSite Not Available
NIHR UCLH Clinical Research Facility
London 2643743, W1T 7HA
United KingdomActive - Recruiting
UAB Comprehensive Cancer Center
Birmingham, Alabama 35249
United StatesSite Not Available
UAB Comprehensive Cancer Center
Birmingham 4049979, Alabama 4829764 35249
United StatesActive - Recruiting
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey 07601
United StatesSite Not Available
John Theurer Cancer Center at Hackensack UMC
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10021
United StatesActive - Recruiting

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