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A PHASE 1/2, MULTICENTER, OPEN-LABEL, STUDY TO DETERMINE THE RECOMMENDED DOSE AND REGIMEN, AND EVALUATE THE SAFETY AND PRELIMINARY EFFICACY OF CC-92480 IN COMBINATION WITH STANDARD TREATMENTS IN SUBJECTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) AND NEWLY DIAGNOSED MULTIPLE MYELOMA (NDMM)

Enrolling

Trial ID:NCT03989414

View complete trial on ClinicalTrials.gov

Protocol #:19-389

877-DF-TRIAL (877-338-7425)

Condition(s):Multiple Myeloma

Phase:I/II

Principal Investigator:Richardson, Paul, G

Site Investigator(s):Raje, Noopur,
Rosenblatt, Jacalyn,

Site Research Nurse(s):Babcock, Elise,
Bright, Susan,
Gammon, Marilyn,
Knudsen, Elisabeth,
Lively, Kathleen, J.
Marzullo, Tess, V.
Nutter, Meredith, Elise
Smith, Caitlin,

Trial Description:
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

Eligibility Requirements:
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
For participants in Cohorts A, B, C, D, E, F, H, I, J, and K the following inclusions will also apply:
- Documented diagnosis of multiple myeloma (MM) and measurable disease
- Documented disease progression during or after their last antimyeloma regimen
- Achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen
Exclusion Criteria:
- Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or clinically significant amyloidosis
- Known central nervous system (CNS) involvement with myeloma
- Received immunosuppressive medication within the last 14 days of initiating study treatment
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment
Other protocol-defined inclusion/exclusion criteria apply

Protocol #: 19-389

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)