This phase II trial tests how well giving elranatamab every 2 weeks or every 4 weeks works for the treatment of newly diagnosed light chain (AL) amyloidosis. AL amyloidosis is a rare blood disorder in which abnormal plasma cells in the bone marrow produce misfolded proteins (light chains) that deposit in organs throughout the body, causing progressive organ damage. The current standard treatment — daratumumab plus bortezomib, cyclophosphamide, and dexamethasone (Dara-CyBorD) — achieves complete blood responses in roughly half of patients. However, many patients do not achieve sufficiently deep or rapid responses, and some cannot tolerate the chemotherapy and steroids in this regimen due to their underlying organ damage and frailty. Elranatamab works by connecting the patient's immune cells (T-cells) directly to the abnormal plasma cells causing amyloidosis, triggering their immune system to destroy those cells. This approach does not use traditional chemotherapy. Giving elranatamab every 4 weeks, instead of every 2 weeks, may allow for the treatment to still be effective while also decreasing the risk of side effects.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07524634.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Sandra Ann Mazzoni
Phone: 216-444-8111
PRIMARY OBJECTIVE:
I. To assess the efficacy of B-cell maturation antigen (BCMA) bispecific in treating patients with newly diagnosed immunoglobulin light chain (amyloid) (AL) amyloid.
SECONDARY OBJECTIVES:
I. To assess time to complete hematologic response (hCR).
II. To assess the overall response rate (ORR).
III. To assess the duration of hematologic response.
IV. To assess the progression free survival (PFS) rate.
V. To assess overall survival.
VI. To assess involved organ responses.
VII. To assess the timing of involved initial organ responses.
VIII. To assess the timing of best organ response.
IX. To assess major organ deterioration progression free survival (MOD-PFS) and event free survival (MOD-EFS).
X. To assess hospitalization rate.
XI. To assess rates of disease and treatment specific adverse events.
XII. To assess minimal residual disease (MRD) negativity rates at end of therapy (after 6 cycles), and 24 months.
XIII. To assess patient quality of life.
XIV. To assess rates of hypogammaglobulinemia, defined as immunoglobulin (Ig) G levels of < 500.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive elranatamab subcutaneously (SC) on days 1, 3, 6 and 14 of cycle 1. Patients then receive elranatamab SC on days 1 and 15 of each cycle thereafter. Cycles repeat every 28 days for 6 cycles total in the absence of disease progression or unacceptable toxicity. Patients undergo whole body bone imaging (magnetic resonance imaging [MRI], positron emission tomography/computed tomography [PET/CT] or CT) during screening, as well as echocardiography, bone marrow biopsy, and blood and urine sample collection throughout the study.
ARM II: Patients receive elranatamab SC on days 1, 3, 6 and 14 of cycle 1. Patients then receive elranatamab SC on day 1 each cycle thereafter. Cycles repeat every 28 days for 6 cycles total in the absence of disease progression or unacceptable toxicity. Patients undergo whole body bone imaging (MRI, PET/CT or CT) during screening, as well as echocardiography, bone marrow biopsy, and blood and urine sample collection throughout the study.
After completion of study treatment, patients are followed up at 30 days, then every 3 months for 18 months, and at 2 years and 5 years.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorSandra Ann Mazzoni
