RecruitingAL Amyloidosis
Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.
Sponsor: Dana-Farber Cancer Institute
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ Prior BCMA-targeting bispecific antibodies or BCMA-targeting CAR-T therapy.
- ✕ Participants refractory to belantamab mafodotin OR participants that have received belantamab as the immediate past line of therapy.
- ✕ Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
- ✕ Participants who are receiving any other investigational agents for this condition.
- ✕ Participants with Stage IIIB Amyloidosis as defined by the 2004 Mayo Clinic Criteria (see above).
- ✕ History of allergic reactions to elranatamab.
- ✕ Participants with an active malignancy (including lymphoma) with the following exceptions: adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer; adequately treated stage I cancer from which the patient is currently in remission and has been for over 2 years; low-risk prostate cancer with a Gleason score \< 7 and prostate specific antigen \< 10ng/mL; other localized, indolent and/or low risk cancer may be permitted
- ✕ Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or 4 months following discontinuation of elranatamab, whichever is longer. Pregnant women are excluded from this study because elranatamab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with elranatamab, breastfeeding should be discontinued if the mother is treated with elranatamab.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06569147 · last updated 2026-08-19