Health Condition 1: C900- Multiple myeloma
Conditions
Interventions
Intervention1: CC-220 (Iberdomide): Provided in form of capsules with dosage strengths 1.3 mg, 1.0 mg, 0.75 mg, 0.6 mg, 0.45 mg. In Stage 1, participants will be randomized equally to following: 0.75
Sponsors
Celgene Corporation
Eligibility
Inclusion criteria
Inclusion criteria: 1) Participants with confirmed diagnosis of symptomatic MM, defined as monoclonal plasma cells in the bone marrow greater than equal to 10% or presence of a biopsy-proven plasmacytoma and documented MM, satisfying at least 1 of the myeloma-defining events as detailed in the International Myeloma Working Group (IMWG) criteria for the diagnosis of myeloma 2) Eastern Cooperative Oncology Group performance status (ECOG) performance status score of 0, 1, or 2 3) Participant has received 3 to 6 cycles of an induction therapy that includes a PI and IMiD (eg, VTd, RVd) with or without a CD38 monoclonal antibody, or VCd, and followed by a single or tandem ASCT. 4) Participants within 12 months from initiation of induction who achieved at least a PR after ASCT with or without consolidation, according to IMWG 2016 criteria.
Exclusion criteria
Exclusion criteria: 1) Participant has progressive disease or clinical relapse following ASCT with or without consolidation or is not responsive to primary therapy 2) Participant has systemic amyloid light-chain amyloidosis or plasma cell leukemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal-protein, and skin abnormalities or Waldenstrom’s macroglobulinemia 3) Participant has smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma 4) Participant has known central nervous system/meningeal involvement of MM. 5) Participant has prior history of malignancies, other than MM, unless the participant has been free of the disease for greater than equal to 5 years 6) Participant has clinically significant impaired cardiac function, or cardiac disease 7) Peripheral neuropathy of Grade greater than equal to 2 8) Participant has received a live vaccine within 3 months of initiating study treatment 9) Known active hepatitis A, B, or C virus infection, or participant is known to be seropositive for human immunodeficiency virus 10) Participant has current or prior use of immunosuppressive medication within 14 days prior to starting therapy with study treatment 11) Received any prior BCMA-directed therapy 12) Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy 13) ANC less than 1,000/µL, Platelet count: less than 75,000 /µL, Hemoglobin less than 8 g/dL, Creatinine clearance (CrCL) less than 30 mL/min, Corrected serum calcium greater than 13.5 mg/dL, Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 2.5 upper limit of normal, Serum total bilirubin greater than 1.5 ULN or greater than 3.0 mg/dL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of iberdomide versus lenalidomide in participants with NDMM after ASCT, as measured by PFS, based on IMWG Uniform Response CriteriaTimepoint: IMWG Uniform Response Criteria is assessed on Day 1 of Cycle 2 till Cycle 26, and then alternate cycles from Cycle 28 until End of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the MRD negativity rate in participants with a response of CR or better at 12 (± 3) months of maintenance treatment with iberdomide versus lenalidomideTimepoint: 12 (± 3) months post start of maintenance treatment;To evaluate OS in participants with NDMM after ASCT treated with iberdomide compared to lenalidomideTimepoint: Death due to any cause | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactShilpi Sinha
Bristol Myers Squibb India Pvt. Ltd.
Outcome results
None listed