Status:
ACTIVE_NOT_RECRUITING
A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma
Lead Sponsor:
Juno Therapeutics, a Subsidiary of Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- 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
- 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, or psychosis
- Other protocol-defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 8 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04674813
Start Date
February 24 2021
End Date
January 8 2026
Last Update
December 23 2025
Active Locations (10)
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1
Local Institution - 005
Birmingham, Alabama, United States, 10016
2
Local Institution - 009
Duarte, California, United States, 91010-301
3
Local Institution - 012
San Francisco, California, United States, 94143
4
Local Institution - 002
Denver, Colorado, United States, 80218