Multiple Myeloma (NDMM)
Conditions
Interventions
Stage 1 Arm A1:Iberdomide(0.75mg)
Stage 1 Arm A3:Iberdomide(1.3mg)
Stage 1 Arm A2:Iberdomide (1.0mg)
Stage 1 Arm B:Lenalidomide
Stage 2 Arm B:Lenalidomide (The same intervention as Stage 1)
Stage 2 Arm A:Iberdomide (Selected Dose 0.75mg in stage 2)
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants with confirmed diagnosis of symptomatic MM, defined as monoclonal plasma cells in the bone marrow >= 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. At enrollment: Eastern Cooperative Oncology Group performance status (ECOG) performance status score of 0, 1, or 2. 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. Post-stem cell transplant consolidation is permitted. 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. 3.For participants who have not received consolidation therapy, the participant must be within 120 days post-transplant at the time of randomization. For participants treated with consolidation therapy, the participant must be within 30-60 days of the last dose of consolidation therapy at the time of randomization and within 180 days post-transplant at the time of randomization. Availability of complete documentation for: Details of initial disease state, initial therapy, and best response achieved ; Cytogenetics assessment at diagnosis or any timepoint prior to ASCT (If local cytogenetic data unavailable, archival sample collected from any time point before ASCT should be submitted to central laboratory for FISH analysis) ; ISS staging at diagnosis (requiring serum ß2 Microglobulin and albumin results at diagnosis).
Exclusion criteria
Exclusion criteria: 1. Participant has progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy. Participant has systemic amyloid light-chain amyloidosis or plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential) or polyneuropathy, organomegaly, endocrinopathy, monoclonal-protein and skin abnormalities (POEMS syndrome);or Waldenstrom’s macroglobulinemia. Participant has smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma. Participant has known central nervous system/meningeal involvement of MM. 2. Physical and Laboratory Test Findings: Participant has any of the following laboratory test result abnormalities: ANC 13.5 mg/dL (> 3.4 mmol/L). Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × upper limit of normal (ULN).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| minimal residual disease negativity rate;overall survival; | — |
Countries
China
Contacts
Public ContactXiaojun Huang
Peking University People's Hospital
Outcome results
None listed