NCT04674813
Recruiting
December 19, 2020
March 2, 2022
Brief summary:
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R MM).
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Administration of CC-95266 |
Drug: CC-95266 Specified dose on specified days Drug: Fludarabine Specified dose on specified days Drug: Cyclophosphamide Specified dose on specified days |
Inclusion Criteria: Age ≥ 18 years Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease Participants must have documented progressive disease on or within 12 months of completing treatment with the last anti-myeloma treatment regimen, except for participants with cellular therapy (eg, Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months Participants must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is considered one regimen), including: Autologous stem cell transplant A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination Anti-CD38 (eg, daratumumab), either alone or combination Measurable disease Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ function Exclusion Criteria: Known active or history of central nervous system (CNS) involvement of MM Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis Active autoimmune disease requiring immunosuppressive therapy History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis Other protocol-defined inclusion/exclusion criteria apply
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.
United States, Alabama
University of Alabama Birmingham
Birmingham
United States, California
City of Hope
Duarte
United States, California
University of California, San Francisco Comprehensive Cancer Center
San Francisco
United States, Colorado
Colorado Blood Cancer Institute
Denver
United States, Maryland
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore
United States, Massachusetts
Dana Farber Cancer Institute
Boston
United States, New York
Mount Sinai Medical Center
New York
United States, Tennessee
Sarah Cannon Research Institute Center for Blood Cancers
Nashville
United States, Texas
Southwestern Medical Center- Harold C Simmons Comprehensive Cancer Center
Dallas
United States, Washington
Swedish Cancer Institute
Seattle
Juno Therapeutics, a Subsidiary of Celgene
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb