Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
Frontline T-cell Engager vs Autologous Stem Cell Transplant and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma (FASTER)
Sponsor: SCRI Development Innovations, LLC + Pfizer, coMMit, Myeloma Trials, Innovated
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Rate of MRD negativity after completion of Maintenance 1
Time frame: At 60 weeks
Secondary Endpoints
Rate of sustained MRD negativity after completion of Consolidation and Maintenance 1 or after completion of Maintenance 1 and Maintenance 2
Event-free survival (EFS)
Incidence of adverse events
Eligibility Criteria
Inclusion Criteria: 1. Age \>18 years with no upper age limit. 2. Newly diagnosed multiple myeloma with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available. 3. Eligible for ASCT according to institutional policy as evaluated by investigator. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Appendix A). 5. Prior induction therapy including one PI, lenalidomide, and an anti-CD38 mAb for 16-24 weeks, obtaining at least a partial response (PR). 6. Measurable disease meeting at least 1 of the following criteria (at the time of diagnosis): a. Serum monoclonal (M) protein ≥1.0 g/dl (≥0.5 g/dl if IgA, IgD, IgE or IgM MM). b. ≥200 mg of M protein/24h in the urine. c. Difference between affected and unaffected free light chain ≥10 mg/dL with abnormal kappa to lambda ratio. 7. Have trackable clonogenic sequence using ClonoSEQ® (Seattle, WA) identi…
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