This phase II trial studies how well measurable residual disease-guided maintenance therapy with elranatamab after an autologous hematopoietic cell transplant (AHCT) works in treating patients with newly diagnosed multiple myeloma. Maintenance treatment after AHCT can help prolong the period of time before a person’s multiple myeloma comes back, but there are side effects associated with long-term use of these drugs after transplant, as well as significant financial costs and time away from work and other responsibilities. A bone marrow test, ClonoSEQ, looks for measurable residual disease, or MRD, in the cells of the bone marrow. MRD is a term used to describe the small number of cancer cells left in the body after cancer treatment. Emerging data has shown that MRD (cancer remaining after treatment) may be an effective marker to guide duration of treatment. Elranatamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving elranatamab after AHCT using MRD guidance may be an effective way find out when to stop and possibly when to restart treatment with elranatamab and help control disease in patients with newly diagnosed multiple myeloma.
Additional locations may be listed on ClinicalTrials.gov for NCT06483100.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Michael Joseph Slade
Phone: 314-454-8304
PRIMARY OBJECTIVE:
I. To generate efficacy data for a bone marrow-based MRD-guided approach to elranatamab maintenance in patients with newly diagnosed multiple myeloma after AHCT.
SECONDARY OBJECTIVES:
I. To describe treatment efficacy as measured by International Myeloma Working Group (IMWG) response criteria, MRD-negativity, sustained MRD-negativity, and time to next therapy using this approach.
II. To characterize the proportion of time off treatment using MRD-guided immunotherapy maintenance post-AHCT.
III. To evaluate safety of this approach as measured by the incidence of treatment-related toxicity and overall survival.
EXPLORATORY OBJECTIVES:
I. To measure quality of life in patients on this protocol during both active treatment and observation.
II. To describe the proportion of patients achieving “deep” MRD by clonoSEQ (i.e. < 10^-6).
III. To describe the sensitivity and specificity of peripheral blood-based MRD with clonotypic mass spectrometry (i.e. the EasyM assay) for bone marrow-based MRD status (i.e. clonoSEQ).
IV. To compare clinical outcomes to a matched historical control treated with standard-of-care maintenance therapy.
OUTLINE:
Patients receive elranatamab subcutaneously (SC) on days 1, 4, 8, 15, and 22 of cycle 1 and days 1 and 15 of subsequent cycles. Cycles repeat every 28 days for at least 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow biopsy and aspiration every 6 months during treatment. Patients with MRD-positive bone marrow test continue to receive elranatamab until 2 MRD-negative bone marrow tests. Patients with 2 MRD-negative bone marrow tests in a row stop receiving elranatamab and are placed on observation. During observation, patients undergo bone marrow biopsy and aspiration every 6 months and any MRD-positive test will result in treatment with elranatamab being re-started. Patients may move back and forth between elranatamab treatment and observation for up to 36 months in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET) as clinically indicated and blood sample collection and bone marrow aspirate throughout the study.
After completion of study treatment, patients are followed up at 90 days and then annually for 5 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorMichael Joseph Slade
