GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5 (HD10/DSMMXX)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: - 18 years of age to 70 years of age, inclusive Have an ECOG performance status score of 0 to 2 at screening Have clinical laboratory values meeting prespecified criteria during the Screening Phase. Participants in Arm A and Arm B must also satisfy all of the following criteria to be enrolled in the study: 1. Documented multiple myeloma requiring treatment as defined by the criteria below: Multiple myeloma diagnosis according to the IMWG diagnostic criteria Measurable disease at screening as defined by any of the following: 1. Serum M-protein level ≥1.0 g/dL or 2. Urine M-protein level ≥200 mg/24 hours or 3. Serum immunoglobulin free light chain level ≥10 mg/dL and abnormal serum free light chain ratio 2. Newly diagnosed participants for whom HDT and ASCT is part of the intended treatment plan. Participants Arm C must also satisfy all of the following criteria: Newly diagnosed multiple myeloma according to IMWG criteria. Must have received 4 to 6 cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or tandem ASCT. Post-ASCT consolidation is permitted for up to 2 cycles as long as the total number of induction plus consolidation cycles does not exceed 6. 3 Must have received only one line of therapy and achieved at least a PR as per IMWG without evidence of progression at the time of enrollment. 4. Must have received HDT and ASCT within 12 months of the start of induction therapy and be within 6 months of the last ASCT at the time of enrollment. In addition, for participants treated with consolidation therapy, the participant must be within 3 months of the last dose of consolidation therapy at the time of enrollment. Exclusion Criteria: - CNS involvement or clinical signs of meningeal involvement of multiple myeloma. - Stroke or seizure within 6 months prior study start. - History of transplantations requiring immunosuppressive therapy. - Seropositive for HIV, HEP B, Active Hep C infection (details see protocol). - COPD with a FEV1 <50% of predicted normal. - Moderate /severe persistent asthma within the past 2 years or any uncontrolled asthma. Exclude if FEV1 <50% of predicted normal. - Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures, or that in the investigators opinion would constitute a hazard for participants. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug/excipients. Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of any study treatment regimen. Plans to father a child while enrolled in this study or within 90 days after the last dose of any component of the study treatment regimen. Arm A and B - Prior or current systemic therapy or stem cell transplant for any plasma cell dyscrasia, with the exception of emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment. - Arm B only: Peripheral neuropathy or neuropathic pain Grade 2 or higher Arm C - Discontinued treatment due to any AE related to lenalidomide as determined by the investigator. Progressed on multiple myeloma therapy at any time prior to screening. Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within the 14 day period before the start of study treatment administration. Intolerant to the starting dose of lenalidomide (10 mg). For further details on inclusion/exclusion criteria please refer to the study protocol.
Sites / Locations
- Charité University Medicin Berlin
- Clinic Chemnitz gGmbHRecruiting
- University Clinic Technical University DresdenRecruiting
- University Clinic FreiburgRecruiting
- Asklepios Clinic Hamburg AltonaRecruiting
- University Hospital HeidelbergRecruiting
- University Clinic Schleswig-Holstein Campus Kiel
- Technical University Munich
- University WürzburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm A Tec-DRd Induction and Tec-DR Maintenance
Arm B Tec-DVRd Induction and Tec-DR Maintenance
Arm C Tec-DR Maintenance
Arm A participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide and dexamethasone in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC and lenalidomide in 18 cycles of maintenance therapy.
Arm B participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab SC, lenalidomide, dexamethasone and bortezomib in 6 cycles of induction therapy, followed by teclistamab SC injection in combination with daratumumab SC and lenalidomide in 18 cycles of maintenance therapy.
Arm C participants will receive 18 cycles of teclistamab SC injection in combination with daratumumab SC and lenalidomide as maintenance therapy.