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

ID#: NCT04674813

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: February 24, 2021

End Date: June 03, 2025

Contact Information:
BMS Study Connect Contact Center www.BMSStudyConnect.com
First line of the email MUST contain the NCT# and Site #.
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).

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