Study for Frail Patients With Newly Diagnosed Multiple Myeloma Treated With Daratumumab With Teclistamab or Talquetamab.

Exclusion Criteria19

• Non-secretory MM or measurable disease by urine or plasmacytoma only
• Central nervous system involvement of myeloma
• Significant pulmonary dysfunction
• Stroke, transient ischemic attack, or seizure within 6 months of eligibility
• Evidence of active systemic viral, fungal, or bacterial infections, requiring systemic antimicrobial therapy
• HIV and Hepatitis infections
• Exclude for any of the following:
• Any history of malignancy other than MM which is considered at high risk of recurrence requiring treatment or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity.
• Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma.
• Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before eligibility
• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients (refer to IB and most recently applicable RSI)
• Extensive radiotherapy within 14 days or focal radiation only within 7 days of eligibility
• Current or active therapy for multiple myeloma or received a cumulative dose corticosteroids equivalent to >40 mg dexamethasone within the 14 days prior to C1D1
• Received a live attenuated vaccine ≤4 weeks before eligibility. Non-live vaccines or non-replicating authorized for emergency use (eg, COVID-19) are allowed
• Received a strong CYP3A4 inducer or use of St. John's wort ≤5 half-lives prior to dosing
• Patient had major surgery or significant traumatic injury within 2 weeks prior to eligibility. Kyphoplasty or Vertebroplasty is not considered major surgery
• Have received an investigational drug (including investigation vaccines) or used an invasive investigational medical device <4 week or 5 PK half-lives, before eligibility or is currently enrolled in an interventional investigational study except if only long-term survival data are collected
• Concurrent medical or psychiatric condition or disease (eg, uncontrolled diabetes, alcohol or drug abuse, severe dementia or altered mental status), that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participation in the study
• Any other issue that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg,, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments