A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

  • Interventional
  • Recruiting
  • NCT03989414
Eligibility Details Visit Clinicaltrials.gov

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)

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

        • 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

At a Glance

National Government IDNCT03989414

IRB#IRB19-0716

Lead SponsorCelgene

Lead PhysicianAndrzej Jakubowiak

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting