A Study of BMS-986393 (CC-95266) in Subjects With Relapsed and/or Refractory Multiple Myeloma

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Overview

The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986393 (CC-95266) in participants with relapsed and/or refractory multiple myeloma (R/R MM).

SparkCures ID 1151
Trial Phase Phase 1
Enrollment 75 Patients
Treatments
Tags
Trial Sponsors
  • Juno Therapeutics, a Subsidiary of Celgene
NCT Identifier

NCT04674813

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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