Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis (NCT06569147) | Clinical Trial Compass
RecruitingPhase 1/2
Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
United States49 participantsStarted 2024-11-01
Plain-language summary
This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.
Who can participate
Age range18 Years
SexALL
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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 bilirubin ≤1.5 × institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN, Creatinine: Calculated clearance ≥30 mL/min using Cockcault-Groft equation
* Participants who received belantamab mafodotin are eligible if discontinued due to intolerance or adverse event.
* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Participants with a history of hepatitis C virus (HCV) i…