A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

Inclusion Criteria

• •1. Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
• •2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.
• •3. NDMM with a requirement for treatment as documented per IMWG criteria.
• •4. Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following:
• •1. Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or
• •2. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L) And/or
• •3. Serum free light-chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65).
• •5. Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to any of the following:
• •1. Exclusion from treatment with ASCT due to country- or site-specific age restriction.
• •2. Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT.
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• •7. Adequate organ system function as defined by the laboratory assessments.
• •8. Male participants:
• •* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• •* Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm:
• •* Refrain from donating fresh unwashed semen
• •PLUS either:
• •* Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.
• •OR
• •* Must agree to use contraception/barrier as detailed below
• •* Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females.
• •9. Female participants
• •* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• •* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
• •* Is not a WOCBP OR
• •* Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency during the Treatment Period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
• •* A WOCBP must have 2 negative highly sensitive serum pregnancy tests before starting treatment, the first may be performed within 14 days from C1D1, the second within 24 hours before the first dose of study intervention.
• •* Should pregnancy occur in a female on treatment or the female partner of a male on treatment, treatment must be stopped, and it is advised to seek advice from a physician specialized or experienced in teratology.