Iberdomide Manteinance Versus Lenalidomide Manteinance Therapy Following Autologous Stem Cell Transplant in Participants with NDMM

Phase 1

Recruiting

• Conditions: ewly Diagnosed Multiple Myeloma (NDMM); MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-501515-14-00
• Lead Sponsor: Celgene Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1216

Inclusion Criteria

At the time of diagnosis: 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 IMWG criteria for the diagnosis of myeloma., At enrollment: Eastern Cooperative Oncology Group performance status performance status score of 0, 1, or 2. Participant has received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory compound (IMiD) with or without a CD38 monoclonal antibody, or bortezomib, cyclophosphamide and dexamethasone 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 partial response after ASCT with or without consolidation, according to IMWG 2016 criteria., 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.

Exclusion Criteria

Participant has progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT or is not responsive to primary therapy., Participant has systemic amyloid light-chain amyloidosis or plasma cell leukemia 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., Participant has any of the following laboratory test result abnormalities: absolute neutrophil count < 1,000/µL; Platelet count: < 75,000/µL; Hemoglobin < 8 g/dL (<4.9 mmol/L; Creatinine clearance < 30 mL/min or requiring dialysis; Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L); Serum aspartate aminotransferase or alanine aminotransferase > 2.5 × upper limit of normal (ULN) or serum total bilirubin > 1.5 × ULN., Peripheral neuropathy of Grade = 2., Received any prior B-cell maturation antigen directed therapy., Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, NK cells).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified