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.
Treatment: Elranatamab — This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.
Check if I qualifyExtracted 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
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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