Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
A Phase I/II, Open Label, Study to Evaluate Safety, Tolerability and Efficacy of Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
Sponsor: Brigham and Women's Hospital
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
To determine RP2D
Time frame: up to 26 months
To evaluate objective response rate (ORR)
Time frame: up to 60 months
Secondary Endpoints
To assess safety and tolerability of elranatamab in patients with relapse or refractory AL amyloidosis
To assess best overall response (BOR)
To assess duration of response (DoR)
Eligibility Criteria
Inclusion Criteria: * Previously diagnosed with AL amyloidosis based on IMWG criteria who have relapsed or refractory disease after treatment with at least one prior line of therapy (minimum 2 cycles). * Participants must have progression of light chain disease, defined as dFLC \>20mg/L. * For Phase 2 only, measurable hematologic disease, satisfying one of the following criteria: Difference between involved and uninvolved free light chain (FLC) over 40 mg/L; Abnormal level of FLC with an abnormal κ/λ ratio (except in participants with CKD stage 3 or higher where a rise of lambda FLC to an abnormal level and of at least 50% over the nadir with a normal κ/λ ratio is acceptable); A serum M spike measuring ≥ 0.5 g/dL * Age ≥ 18 years * ECOG performance status ≤2 or Karnofsky ≥60% * Participants must meet the following organ and marrow function as defined below: Absolute leukocyte count ≥3,000/mcL , Absolute neutrophil count ≥1,000/mcL, Absolute platelet count ≥75,000/mcL , Direct bilirubi…
Read full criteria on CT.gov →✦ Analyst Commentary
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