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Recruiting

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma - CC-98633-MM-001

Updated: 4 March, 2021   |   ClinicalTrials.gov

Juno Therapeutics and Celgene are wholly owned subsidiaries of Bristol-Myers Squibb Company

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 10

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: CC-98633
Biological: CC-98633

Key Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years. 2. Signed written informed consent prior to any study procedure. 3. Relapsed and/or refractory multiple myeloma (MM). Subjects must have received at least 3 prior antimyeloma treatment regimens. Subjects must have documented progressive disease during or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry. Also, subjects with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent anti-myeloma treatment regimen afterwards will be also eligible. Subjects must have previously received all of the following therapies: 1. Autologous stem cell transplant 2. A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination 3. Anti-CD38 (eg, daratumumab), either alone or combination 4. Measurable disease 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. 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. Prior treatment with CAR T-cell or another genetically modified T-cell therapy 4. Prior treatment with investigational therapy directed at BCMA 5. Uncontrolled or active infection 6. Active autoimmune disease requiring immunosuppressive therapy 7. 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

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Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com