A study comparing treatment with teclistamab and talquetamab versus daratumumab and lenalidomide in patients with multiple myeloma after stem cell transplant who still have detectable disease

Prior treatment

• Significant concurrent medical or psychiatric conditions that may increase risk to the participant, interfere with study participation, or confound study results, including active serious infections or autoimmune diseases (except as allowed per protocol)
  • Contraindications, hypersensitivity, or intolerance to any study drug or required concomitant medication.
  • Prohibited prior or concomitant therapies or procedures, including recent disallowed treatments, plasmapheresis, major surgery, or live attenuated vaccination within protocol defined timeframes
  • Active viral infections, including HIV infection, hepatitis B infection, or active hepatitis C infection

Other illness

• Clinically significant neurologic conditions, including symptomatic peripheral neuropathy Grade ≥2 or central nervous system involvement by multiple myeloma.
• Significant pulmonary disease, including severe or uncontrolled asthma or chronic obstructive pulmonary disease with clinically relevant respiratory impairment
• Other malignancies than multiple myeloma that are active or considered at high risk of recurrence, except for malignancies considered cured as defined in the protocol
• Hematologic disorders other than multiple myeloma, including plasma cell leukemia, Waldenström’s macroglobulinemia, POEMS syndrome, or AL amyloidosis
• Clinically significant cardiovascular disease, including uncontrolled heart failure, recent myocardial infarction, severe arrhythmias, or clinically relevant ECG abnormalities

• Adults (≥18 years) with a documented diagnosis of multiple myeloma according to IMWG criteria
• Newly diagnosed patients who have completed single or tandem autologous stem cell transplantation (ASCT) following standard induction therapy including an anti CD38 antibody, an immunomodulatory drug, and a proteasome inhibitor.
• Positive measurable residual disease (MRD) in bone marrow at a sensitivity threshold of 10⁻⁵, assessed after ASCT and prior to randomization
• Patients within the protocol defined time window after ASCT, with or without consolidation therapy
• Adequate performance status (Karnofsky ≥50% / ECOG ≤2)
• Adequate organ function, including hematologic, renal, hepatic, and calcium parameters, as defined in the protocol
• Agreement to comply with protocol specified contraceptive requirements, where applicable
• Written informed consent obtained prior to any study specific procedures