Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients

Inclusion Criteria:

1. Participant must have documented MM satisfying the IMWG criteria.

2. Newly diagnosed patients eligible for high dose therapy and ASCT.

3. ECOG performance status score ≤2.

4. HIV-positive participants are eligible if they meet all of the following

5. No detectable viral load (ie, <50 copies/mL) at screening

6. CD4+ count >300 cells/mm3 at screening

7. No AIDS-defining opportunistic infection within 6 months of screening

8. Receiving HAART. Any changes in HAART due to resistance/progression shouldoccur at least 3 months prior to screening. A change in HAART due to toxicityis allowed up to 4 weeks prior to screening.

9. Must sign an ICF indicating that the participant understands the purpose of, andprocedures required for, the study and is willing to participate in the study.

10. Willing and able to adhere to the lifestyle restrictions specified in this protocol.

11. A female participant of childbearing potential must have a negative highly sensitiveserum (β hCG) pregnancy test at screening

12. A female participant must be

13. Not of childbearing potential or

14. Of childbearing potential and practicing true abstinence; or have a solepartner who is vasectomized; or practicing 2 effective methods of contraception

15. A female participant must agree not to donate eggs or freeze for future use duringthe study and for 6 months after receiving the last dose of study treatment.

16. A male participant must wear a condom when engaging any sexual activity that allowsfor passage of ejaculate to another person during the study and for a minimum of 100days after receiving the last dose of study treatment.

17. A male participant must agree not to donate sperm for the purpose of reproductionduring the study and for a minimum of 100 days after receiving the last dose ofstudy treatment.

18. Have clinical laboratory values meeting the following criteria

19. Hemoglobin ≥8 g/dL

20. Platelets ≥75×109/L

21. ANC ≥1.0×109/L

22. AST and ALT ≤2.5×ULN

23. eGFR ≥30 mL/min

24. Total bilirubin <1.5×ULN

Exclusion Criteria:

1. Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chainamyloidosis.

2. Known active CNS involvement or exhibits clinical signs of meningeal involvement ofMM. If either is suspected, negative whole brain MRI and lumbar cytology arerequired.

3. Peripheral neuropathy or neuropathic pain Grade 2 or higher

4. Excluded for any of the following:

5. Any ongoing myelodysplastic syndrome or B cell malignancy (other than MM).

6. Any history of malignancy, other than MM, which is considered at high risk ofrecurrence requiring systemic therapy.

7. Any active malignancy (ie, progressing or requiring treatment change in thelast 24 months) other than MM. The only allowed exceptions are malignanciestreated within the last 24 months that are considered cured:

8. Non-muscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, <3cm, no CIS).

9. Non-melanoma skin cancers treated with curative therapy or localizedmelanoma treated with curative surgical resection alone.

10. Non-invasive cervical cancer.

11. Breast cancer: adequately treated lobular carcinoma in situ or ductalcarcinoma in situ or history of localized breast cancer (anti-hormonaltherapy is permitted).

12. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treatedlocally only (RP/RT/focal treatment).

13. Other malignancy that is considered cured with minimal risk of recurrencein consultation with the sponsor's medical monitor.

14. Stroke within 6 months prior to signing ICF.

15. Presence of the following cardiac conditions:

16. New York Heart Association stage III or IV congestive heart failure (seeAppendix )

17. Myocardial infarction or coronary artery bypass graft ≤6 months prior toenrollment, or an unstable or uncontrolled disease/condition related to oraffecting cardiac function (eg, unstable angina)

18. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities

19. History of clinically significant ventricular arrhythmia or unexplainedsyncope, not believed to be vasovagal in nature or due to dehydration

20. History of severe non-ischemic cardiomyopathy

21. Concurrent medical or psychiatric condition or disease that is likely to interferewith study procedures or results, or that in the opinion of the investigator wouldconstitute a hazard for participating in this study, such as:

22. Uncontrolled diabetes

23. Evidence of active systemic viral, fungal, or bacterial infection, requiringsystemic antimicrobial therapy

24. History of autoimmune disease with the exception of vitiligo, type I diabetes,and prior autoimmune thyroiditis that is currently euthyroid based on clinicalsymptoms and laboratory testing

25. Gastrointestinal disease that may significantly alter the absorption of oraldrugs

26. Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia,or altered mental status

27. Any other issue that would impair the ability of the participant to receive ortolerate the planned treatment at the investigational site, to understand informedconsent or any condition for which, in the opinion of the investigator,participation would not be in the best interest of the participant (eg, compromisethe well-being) or that could prevent, limit, or confound the protocol-specifiedassessments

28. Contraindications or life-threatening allergies, hypersensitivity, or intolerance toany study drug or its excipients

29. Any of the following:

30. Hepatitis B infection (ie, HBsAg or HBV-DNA positive).

31. Active hepatitis C infection as measured by positive HCV-RNA testing.

32. Prior or current systemic therapy or stem cell transplantation for any plasma celldyscrasia, with the exception of emergency use of a short course (equivalent ofdexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.

33. Major surgery within 2 weeks prior to the start of administration of studytreatment, or will not have fully recovered from surgery, or has major surgeryplanned during the time the participant is expected to be treated in the study orwithin 2 weeks after administration of the last dose of study treatment.

34. Contraindications to the use of Dara-VRd per SmPC.

35. Prior or concurrent exposure to any of the following, in the specified time frameprior to first dose of study treatment:

36. Investigational vaccine other than SARS-CoV-2 vaccine approved/in use underemergency approval within 4 weeks. Non-live or non-replicating vaccinesauthorized for emergency use (eg, COVID-19) by local health authorities areallowed.

37. Live, attenuated vaccine within 4 weeks

38. Monoclonal antibody therapy within 21 days (not used for the treatment of MM)

39. Received a strong CYP3A4 inducer within 5 half-lives prior to start ofadministration of study treatment

40. Participant is pregnant, breastfeeding, or planning to become pregnant whileenrolled in this study or within 6 months after the last dose of study treatment.

41. Participant plans to father a child while enrolled in this study or within 100 daysafter the last dose of study treatment.