Actively Recruiting
Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
Led by Brigham and Women's Hospital · Updated on 2026-03-06
49
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.
CONDITIONS
Official Title
Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously diagnosed with AL amyloidosis based on IMWG criteria with relapsed or refractory disease after at least one prior line of therapy (minimum 2 cycles)
- Progression of light chain disease with difference between involved and uninvolved free light chain (dFLC) >20 mg/L
- For Phase 2, measurable hematologic disease defined by specific free light chain or serum M spike criteria
- Age 18 years or older
- ECOG performance status of 0 to 2 or Karnofsky score of 60% or higher
- Adequate organ and marrow function including leukocyte count ≥3,000/mcL, neutrophil count ≥1,000/mcL, platelet count ≥75,000/mcL, bilirubin ≤1.5 × ULN, AST/ALT ≤3 × ULN, and creatinine clearance ≥30 mL/min
- Eligible if previously treated with belantamab mafodotin but discontinued due to intolerance or adverse event
- For chronic hepatitis B virus infection, viral load must be undetectable on therapy if indicated
- For hepatitis C virus infection, must be treated and cured or have undetectable viral load if currently on treatment
- Cardiac stage I, II, or IIIa AL amyloidosis based on specific staging criteria
- Agreement to use effective contraception during the study and for 90 days after last dose
- Ability and willingness to provide informed consent and undergo study procedures including bone marrow biopsies
- Prior treatment with Daratumumab plus CyBorD
You will not qualify if you...
- Prior treatment with BCMA-targeting bispecific antibodies or CAR-T therapy
- Refractory to belantamab mafodotin or received it as the immediate past therapy
- Unresolved adverse events from prior cancer therapy greater than Grade 1 except alopecia
- Receiving other investigational agents for this condition
- Stage IIIB amyloidosis as per 2004 Mayo Clinic Criteria
- History of allergic reaction to elranatamab
- Active malignancy except certain treated and low-risk cancers in remission
- Pregnant, breastfeeding, or planning pregnancy during or shortly after the study
- Medical, social, or psychological factors affecting safety or consent
- Active multiple myeloma with CRAB criteria
- Clinically significant active autoimmune diseases
- HIV positive
- Severe uncontrolled orthostatic hypotension causing syncope despite treatment
- Planned autologous stem cell transplant within first 6 months of therapy
- Recent acute coronary syndrome or uncontrolled arrhythmias within 3 months
- Left ventricular ejection fraction below 30%
- Severe valvular stenosis or severe congenital heart disease
- History of serious ventricular arrhythmias without pacemaker or defibrillator
- QTcF interval greater than 550 msec without pacemaker or defibrillator
- Acute myocardial ischemia or active conduction system abnormalities on ECG except specified benign conditions
- Major surgery requiring general anesthesia within 4 weeks before randomization or planned during study
- NYHA Class IV heart failure or acute congestive heart failure decompensation
- Eligible for transplant but have not undergone transplant yet
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
G
Giada Bianchi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here