A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
Date de révision : 27/04/2026
96 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 02/09/2024
Critères :
Critères d'inclusion :
- 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 (single transplant) or 15 months (tandem transplant) 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 of the last 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 of the last transplant at the time of randomization.
Critères d'exclusion :
- 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).
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Departmental Hospital Vendee
85925 La Roche Sur Yon Cedex 9 France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".