GMMG-HD11/DSMM XXI/64007957MMY3010

This is an open-label, randomized interventional multicenter Phase 3 clinical trial to investigate the efficacy and safety of Tec-DRd induction therapy and fixed-duration Tec-D maintenance post ASCT in adult participants with TE NDMM, compared with the SoC PERSEUS regimen. A total of 399 participants with TE NDMM aged ≥18 and ≤70 years and an Eastern CooperativeOncology Group (ECOG) status 0-2 will be included. The primary objective of the clinical trial: To determine the efficacy of Tec-DRd compared to DVRd after 6 cycles of induction/consolidation therapy and HD melphalan and ASCT, before start of maintenance therapy in participants with TE NDMM. Endpoint: Cumulative MRD negativity by NGS at a sensitivity level of 10-6 before start of maintenance therapy.

Inclusion Criteria: 1. 18 to 70 years of age, inclusive. 2. Documented MM as defined by the criteria below: 1. MM diagnosis according to IMWG diagnostic criteria (Appendix 3), 2. Untreated MM requiring systemic therapy, 3. Measurable disease at screening, as defined by any of the following: i. Serum M-protein level ≥1.0 g/dL (central laboratory); or ii. Urine M-protein level ≥200 mg/24 hours (central laboratory); or iii. Serum immunoglobulin free light chain ≥10 mg/dL (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio. 3. Have an ECOG performance status 0-2 (Appendix 5) at screening and immediately prior to the start of administration of study treatment. 4. Have clinical laboratory values meeting the following criteria during the screening period. Refer to Section 5.4.3 for criteria prior to first dose. Hemoglobin ≥7.5 g/dL (≥4.65 mmol/L; without prior RBC transfusion ≤7 days before the screening laboratory test; recombinant human erythropoietin use is permitted). Platelets ≥75×109/L in participants in whom \2.0×ULN, then direct bilirubin ≤1.5×ULN is required). eGFR ≥30 mL/min based on Cockcroft-Gault formula or creatine clearance measured by a 24-h urine collection. Serum calcium corrected for albumin ≤14 mg/dL (≤3.5 mmol/L) or free ionized calcium ≤6.5 mg/dL (≤1.6 mmol/L; see Appendix 10). 5. Eligible for HD melphalan and ASCT (in the opinion of the investigator). 6. A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and again either a serum or urine pregnancy test within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study. 7. A female participant must be (as defined in Appendix 1): 1. Not of childbearing potential, or 2. Of childbearing potential and practicing at least 1 highly effective method of contraception 8. A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment. Female participants should consider preservation of eggs prior to study treatment because anticancer treatments may impair fertility. 9. A male participant must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for 10. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for 3 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment as anticancer treatments may impair fertility. 11. Must agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy. 12. Must sign an ICF indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. 13. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol Exclusion Criteria: 1. Any ongoing myelodysplastic syndrome or B-cell malignancy (other than MM). 2. Any history of malignancy, other than MM, which is considered at high risk of recurrence requiring systemic therapy. 3. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than MM. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured: 1. Nonmuscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, \