Multiple Myeloma Clinical Trial

A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 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, or psychosis

Other protocol-defined inclusion/exclusion criteria apply.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT04674813

Recruitment Status:

Recruiting

Sponsor:

Juno Therapeutics, a Subsidiary of Celgene

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There are 11 Locations for this study

See Locations Near You

University of Alabama Birmingham
Birmingham Alabama, 10016, United States More Info
Susan Bal, Site 005
Contact
205-934-1908
City Of Hope
Duarte California, 91010, United States More Info
Myo Htut, Site 009
Contact
626-256-4673
University of California, San Francisco Comprehensive Cancer Center
San Francisco California, 94143, United States More Info
Thomas Martin, Site 012
Contact
415-353-9365
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Tara Gregory, Site 002
Contact
720-754-4800
Local Institution - 008
Baltimore Maryland, 21201, United States More Info
Site 008
Contact
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Omar Nadeem, Site 010
Contact
617-632-3000
Mount Sinai Medical Center
New York New York, 10029, United States More Info
Adriana Rossi, Site 011
Contact
646-962-6500
Sarah Cannon Research Institute Center for Blood Cancers
Nashville Tennessee, 37203, United States More Info
Jesus Berdeja, Site 001
Contact
615-329-0570
Southwestern Medical Center- Harold C Simmons Comprehensive Cancer Center
Dallas Texas, 75390, United States More Info
Larry Anderson, Site 006
Contact
214-648-5906
Swedish Cancer Institute
Seattle Washington, 98104, United States More Info
Daniel Egan, Site 003
Contact
617-699-2437
Local Institution - UNK11
Seattle Washington, 98105, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT04674813

Recruitment Status:

Recruiting

Sponsor:


Juno Therapeutics, a Subsidiary of Celgene

How clear is this clinincal trial information?

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