Myeloma: Clinical Trials Open for Enrollment
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Eligibility
- Male or female, 18 years or older
- Diagnosis of MM as defined according to IMWG criteria1 with measurable disease at diagnosis as defined by serum M-protein ≥0.5 g/dL (5 g/L), by urine M-protein ≥200 mg/24 hours, or by serum free light chain (FLC) assay with involved FLC level ≥10 mg/dL, provided serum FLC ratio is abnormal
- History of 3 to 8 cycles of induction therapy for NDMM, followed by high dose therapy and ASCT. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT. Screening tests should be performed after the last dose of consolidation
- PR or better according to IMWG criteria at the time of randomization
- Identification of the dominant malignant (index) clone as assessed by central laboratory NGS test (Adaptive Biotechnologies clonoSEQ assay
- A bone marrow aspirate sample collected at screening is required to determine MRD status
- ECOG performance status ≤1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
- Not pregnant and willing to use contraception
- Exclusion Criteria
- Plasma cell leukemia defined as more than 20% circulating plasma cells and an absolute count >2 × 10 ⁹ /L plasma cells in peripheral blood) ².
- Amyloidosis, Waldenström’s macroglobulinemia, or Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, Skin changes (POEMS) syndrome
- Known active central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement
- Ongoing Grade ≥3 peripheral sensory or motor neuropathy
- History of Guillain-Barré syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy
- Live attenuated vaccine within 4 weeks of the first dose
- Known or suspected hypersensitivity to the study interventions or any of its excipients
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per the investigator
- Previous MM maintenance treatment
- Prior treatment with B-cell maturation antigen (BCMA) targeted therapy
Enrollment Status: Actively enrolling
Study Information
ClinicalTrials.gov | NCT05317416
Principal Investigator
Amir Steinberg, MD
Contact for Study Screening