A Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma
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What's the purpose of this trial?

This is a Phase 1, multicenter, open label, study of CC-95266 in subjects with relapsed and/or refractory multiple myeloma. The study will consist of two parts: dose escalation (Part A) and dose expansion (Part B).  The dose escalation (Part A) of the study will evaluate the safety and tolerability of increasing doses of CC-95266 in a single administration to establish a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and the dose expansion (Part B) of the study will further evaluate the safety, pharmacokinetics (PK)/ pharmacodynamics (PD), and efficacy of CC-95266 at the RP2D.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Signed written informed consent prior to any study procedure.
  3. Subject has a diagnosis of multiple myeloma with relapsed and/or refractory disease. Subjects must have documented progressive disease on or within 12 months of completing treatment with the last anti-myeloma treatment regimen, except for subjects with cellular therapy (eg, CAR T-cell therapy) as their last treatment, who may enroll beyond 12 months.
  4. Subjects must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without 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
  5. Measurable disease
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  7. Adequate organ function

Exclusion Criteria:

  1. Known active or history of central nervous system (CNS) involvement of MM
  2. Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
  3. Uncontrolled or active infection
  4. Active autoimmune disease requiring immunosuppressive therapy
  5. 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

Additional Trial Information

Phase 1

Enrollment: 77 patients (estimated)

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Alabama

UAB Comprehensive Cancer Center University of Alabama at Birmingham

Birmingham, AL

Open and Accepting

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Colorado

Maryland

Massachusetts

Dana-Farber Cancer Institute

Boston, MA

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Not Yet Accepting

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Not Yet Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

Washington

Swedish Cancer Institute Cherry Hill Campus

Seattle, WA

Not Yet Accepting
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