Sequential Therapy in Multiple Myeloma Guided by MRD Assessments
Trial Parameters
Brief Summary
This research study will determine the proportion of patients with lowest minimal residual disease (MRD) response obtainable after receiving 6 cycles of study treatment. Minimal residual disease is multiple myeloma cells below the level of 1 cancer cell out of 100,000 in the bone marrow. For patients who become MRD "negative" (i.e. less than 1 cancer cell out of 100,000) at the end of 6 cycles of therapy, this study will study if that good response can be maintained with 3 additional cycles of treatment instead of use of autologous hematopoietic cell transplantation (AHCT). For patients who are MRD "positive" at the end of 6 cycles of therapy, this study will answer whether more patients can become and remain MRD "negative" with AHCT plus teclistamab in combination with daratumumab when compared with patients who undergo AHCT followed by lenalidomide (an established anti-myeloma drug) plus daratumumab.
Eligibility Criteria
Inclusion Criteria: 1. Age\>18 years with no upper age limit 2. Newly diagnosed multiple myeloma with indication for initiation of therapy. 3. ECOG performance status 0-2 4. No prior MM-directed therapy except for dexamethasone (up to 160 mg) and/or bortezomib (up to 5.2 mg/m2) and/or cyclophosphamide up to 1000 mg/m2 and/or lenalidomide (up to 21 days of therapy) administered for no longer than 4 weeks prior to enrollment (pre induction). If subject received any prior therapy, pretreatment parameters necessary for disease characterization and response assessment must be available. 5. Measurable disease meeting at least one of the following criteria (at screening or prior to pre induction): 1. Serum monoclonal (M) protein ≥1.0 g/dl (≥0.5 g/dl if IgA, IgD, IgE or IgM multiple myeloma) 2. ≥ 200 mg of M protein/24h in the urine 3. Difference between affected and unaffected free light chain ≥10 mg/dL with abnormal kappa to lambda ratio. 6. Have clinical laboratory values meeting the follow