Actively Recruiting
A Phase I/II Open Label Study to Evaluate Safety, Tolerability, and Efficacy of 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of elranatamab in patients with relapsed or refractory light chain (AL) amyloidosis. This Phase I/II, open-label study aims to find the recommended dose and assess response rates in patients who have previously received treatment but experienced disease progression. The study is sponsored by Brigham and Women's Hospital and includes participants aged 18 and older with specific disease and health criteria. The study includes two phases. Phase I will enroll 4 to 20 participants to determine the safe dose by monitoring dose-limiting toxicities. Participants will receive elranatamab subcutaneously with doses varying in cycles over 28-day periods. Phase II will enroll an additional 29 participants who will receive the recommended Phase II dose identified in Phase I. Treatment lasts for six cycles of 28 days each, with dosing schedules adjusted based on treatment response. Participants will be closely monitored through hospital stays during initial dosing, blood tests, bone marrow biopsies, and other assessments to measure disease response and safety. Researchers will track response rates, duration of response, survival, and adverse events including specific syndromes related to immune response. The study may continue up to several years to observe long-term outcomes and safety. Participants must agree to contraception and follow study procedures for the duration of the trial.
CONDITIONS
Brief Title
Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with AL amyloidosis that has relapsed or is refractory after at least one prior therapy of 2 cycles or more
- Disease progression with difference in free light chains (dFLC) greater than 20 mg/L
- For Phase 2: measurable hematologic disease with specific free light chain or serum M spike criteria
- ECOG performance status of 2 or less or Karnofsky score 60% or higher
- Adequate organ and marrow function as defined by leukocyte, neutrophil, platelet counts, liver function, and creatinine clearance
- Previous treatment including Daratumumab plus CyBorD
- Controlled or cured hepatitis B or C infection if applicable
- Cardiac stage I, II or IIIa AL amyloidosis
- Agreement to use contraception if of childbearing potential
- Ability and willingness to provide informed consent and undergo study procedures including bone marrow biopsies
You will not qualify if you...
- Prior treatment with BCMA-targeting bispecific antibodies or CAR-T therapy
- Refractory to belantamab mafodotin or treated with it as last therapy
- Unresolved toxicities from prior anti-cancer therapy above grade 1 except alopecia
- Receiving other investigational agents for AL amyloidosis
- Stage IIIB amyloidosis
- History of allergic reactions to elranatamab
- Active malignancy except certain treated or low-risk cancers
- Pregnant, breastfeeding, or planning pregnancy during or shortly after study
- Medical, social, or psychological factors affecting safety or consent
- Active multiple myeloma with CRAB criteria
- Active significant autoimmune diseases
- HIV positive
- Severe uncontrolled orthostatic hypotension causing fainting
- Planned stem cell transplant within 6 months
- Recent acute coronary syndrome or uncontrolled arrhythmias
- Severe heart dysfunction or valve disease
- History of serious ventricular arrhythmias without pacemaker/defibrillator
- Prolonged QT interval on ECG without device
- Recent major surgery or planned surgery during study
- NYHA class IV heart failure or acute decompensation
- Eligible for transplant but not yet transplanted
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 cycles of 28 days each
Participants receive subcutaneous elranatamab treatment in cycles of 28 days each, up to 6 cycles. Phase 1 participants are hospitalized during the first cycle for monitoring, with hospitalization lasting 5 to 9 days depending on enrollment order. Dose schedules vary depending on cohort and response, with doses administered on specific days within each cycle.
Multiple visits corresponding to dosing days each cycle; first cycle includes hospitalization for 5 to 9 days
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
G
Giada Bianchi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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