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OncoMatch/Clinical Trials/NCT06569147

Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis

Is NCT06569147 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Elranatamab for al amyloidosis.

Phase 1/2RecruitingBrigham and Women's HospitalNCT06569147Data as of May 2026

Treatment: ElranatamabThis study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Disease stage

Required: Stage I, II, IIIA

Excluded: Stage IIIB

Performance status

ECOG OR KARNOFSKY 0–2

ECOG performance status ≤2 or Karnofsky ≥60%

Prior therapy

Min 1 prior line

Must have received:

relapsed or refractory disease after treatment with at least one prior line of therapy (minimum 2 cycles)

Must have received: (daratumumab)

Participants should have received prior treatment with Daratumumab + CyBorD.

Cannot have received: BCMA-targeting bispecific antibody

Prior BCMA-targeting bispecific antibodies

Cannot have received: BCMA-targeting CAR-T therapy

Prior BCMA-targeting CAR-T therapy

Cannot have received: (belantamab mafodotin)

Exception: allowed if discontinued due to intolerance or adverse event; excluded if refractory or if received as immediate past line

Participants refractory to belantamab mafodotin OR participants that have received belantamab as the immediate past line of therapy

Lab requirements

Blood counts

Absolute leukocyte count ≥3,000/mcL, Absolute neutrophil count ≥1,000/mcL, Absolute platelet count ≥75,000/mcL

Kidney function

Creatinine: Calculated clearance ≥30 mL/min using Cockcault-Groft equation

Liver function

Direct bilirubin ≤1.5 × institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN

Cardiac function

LVEF ≥ 30% by echocardiogram at Screening; no severe valvular stenosis (valve area < 1.0 cm2); no severe congenital heart disease; no history of sustained ventricular tachycardia or aborted ventricular fibrillation or a history of atrioventricular nodal or sinoatrial nodal dysfunction if a permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) is not placed; QTcF ≤ 550 msec on Screening ECG unless PPM/ICD implanted; no acute myocardial ischemia or active conduction system abnormalities except as specified; no NYHA class IV symptoms or acute decompensation of CHF

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; Evidence of LV systolic dysfunction as defined by LVEF is < 30% by echocardiogram at Screening per site cardiology interpretation; Presence of severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area < 1.0 cm2) or severe congenital heart disease; Have history of sustained ventricular tachycardia or aborted ventricular fibrillation or a history of atrioventricular nodal or sinoatrial nodal dysfunction if a permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) is not placed; QT corrected by Fridericia (QTcF) is > 550 msec on Screening ECG unless they have a PPM/ICD implanted; Screening EKG showing acute myocardial ischemia or active conduction system abnormalities with the exception of any of the following: First degree atrioventricular block; Second degree atrioventricular block Type 1 (Mobitz Type 1/Wenckebach type); Right or left bundle branch block (e.g., Left Bundle Branch Block, Right Bundle Branch Block, Left Anterior Fascicular Block, or Left Posterior Fascicular Block); Atrial fibrillation with a controlled ventricular rate; Bifascicular block assessed as benign by the Investigator; NYHA class IV symptoms or participants with acute decompensation of congestive heart failure.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Dana-Farber Cancer Institute · Boston, Massachusetts

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