A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma
NCT ID: NCT04674813
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
180 participants
INTERVENTIONAL
2021-02-24
2026-01-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of CC-95266
CC-95266
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Bendamustine
Specified dose on specified days
Interventions
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CC-95266
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Bendamustine
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Participants must have confirmed progressive disease (as per IMWG criteria) on or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen, except for participants with cellular therapy (e.g., Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months.
* Participants in Part A, and Part B Cohort A, and Part B Cohort B 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).Subjects in Part B Cohort C only must have received at least 1 but not greater than 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent including:
* Autologous HSCT, unless the subject was ineligible
* A regimen that included an immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), either alone or combination
* Anti-CD38 (e.g., daratumumab), either alone or combination. Subjects in Cohort C do not require prior anti-CD38 antibody therapy.
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ function
Exclusion Criteria
* 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, or psychosis
18 Years
ALL
No
Sponsors
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Juno Therapeutics, a Subsidiary of Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 005
Birmingham, Alabama, United States
Local Institution - 009
Duarte, California, United States
Local Institution - 012
San Francisco, California, United States
Local Institution - 002
Denver, Colorado, United States
Local Institution - 008
Baltimore, Maryland, United States
Local Institution - 010
Boston, Massachusetts, United States
Local Institution - 011
New York, New York, United States
Local Institution - 001
Nashville, Tennessee, United States
Local Institution - 006
Dallas, Texas, United States
Local Institution - 003
Seattle, Washington, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1260-4921
Identifier Type: REGISTRY
Identifier Source: secondary_id
CC-95266-MM-001
Identifier Type: -
Identifier Source: org_study_id