A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2023
INTERVENTION: Arm A1: Iberdomide Dose 1 Arm A2: Iberdomide Dose 2 Arm A3: Iberdomide Dose 3 Arm B: Lenalidomide Specified dose on specified days CONDITION: Multiple Myeloma PRIMARY OUTCOME: Progression‐free survival (PFS) [ Time Frame: Up to 6 years ] INCLUSION CRITERIA: ‐ Confirmed diagnosis of symptomatic multiple myeloma (MM) ‐ Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2 ‐ Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or bortezomib, cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post‐stem cell transplant consolidation is permitted ‐ Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria SECONDARY OUTCOME: 1. Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (+‐ 3) months of maintenance treatment [ Time Frame: Up to 6 years ]; 2. Overall Survival [ Time Frame: Up to 12 years ]; 3. Recommended iberdomide dose for Stage 2 [ Time Frame: Up to 1 year ]; 4. Area under the iberdomide plasma concentration‐time curve from time zero to tau [ Time Frame: Up to 1 year ]; 5. Area under the iberdomide plasma concentration‐time curve within a dosing interval AUC (TAU) [ Time Frame: Up to 1 year ]; 6. Maximum iberdomide concentration (Cmax) [ Time Frame: Up to 1 year ]; 7. Time to maximum iberdomide plasma concentration (Tmax) [ Time Frame: Up to 1 year ]; 8. Number of participants with adverse events (AEs) [ Time Frame: Up to 6 years ]; 9.Progression‐free survival on next line of treatment (PFS2) [ Time Frame: Up to 6 years ]; 10.Achieving MRD negativity in participants with CR or better at any time after the date of randomization [ Time Frame: Up to 6 years ]; 11. Conversion from MRD positive to MRD negative in participants with CR or better [ Time Frame: Up to 6 years ]; 12. Achievement of CR or better and maintaining MRD‐negative status in 2 bone marrow aspirate assessments that are a minimum of 6 months or 1 year apart, without any examination showing MRD positive status in between assessments [ Time Frame: Up to 6 years ]; 13. Time to progression (TTP) [ Time Frame: Up to 6 years ]; 14. Time to next treatment (TTNT) [ Time Frame: Up to 6 years ]; 15. Best response achieved prior to progressive disease (PD) [ Time Frame: Up to 6 years ]; 16. Patient‐reported health‐related quality of life (HRQoL) outcomes and multiple myeloma‐related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ‐C30) [ Time Frame: Up to 6 years ]; 17. Patient‐reported HRQoL outcomes and multiple myeloma‐related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ‐MY20) [ Time Frame: Up to 6 years ]
Epistemonikos ID: e9cbd91bc20366f6c541af479dd05be61916139c
First added on: Aug 26, 2024