This phase I trial tests the safety, side effects, and how well a vaccine (DC/MM fusion) in combination with elranatamab works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). The DC/MM fusion vaccine tries to help the immune system recognize and fight against cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines are being studied to see if they can fight cancers that are already in the body. This vaccine is individualized for each patient using dendritic cells (type of immune cells). Laboratory studies have shown that when dendritic cells and cancer cells are brought together, the dendritic cells can stimulate immune responses against the cancer and, in some cases, cause the cancer to shrink. Elranatamab is a type of immunotherapy that works by bringing healthy T cells (immune cells that help kill cancer cells) and myeloma cells close together so the T cells can more effectively kill the myeloma cells. Giving the DC/MM fusion vaccine in combination with elranatamab may be safe, tolerable and/or effective in treating patients with relapsed or refractory multiple myeloma.
Additional locations may be listed on ClinicalTrials.gov for NCT06799026.
Locations matching your search criteria
United States
Massachusetts
Boston
Beth Israel Deaconess Medical CenterStatus: Active
Contact: David E. Avigan
Phone: 617-667-9920
Dana-Farber Cancer InstituteStatus: Approved
Contact: David E. Avigan
Phone: 617-667-9920
PRIMARY OBJECTIVES:
I. To assess feasibility of administration of autologous dendritic cell/myeloma fusion vaccine (DC/MM fusion vaccine) in combination with elranatamab in participants with relapsed/refractory multiple myeloma.
II. To assess effect of DC/MM fusion vaccine on elranatamab toxicity including cytokine release syndrome, neurotoxicity and infections.
III. To assess impact of DC/MM fusion vaccine in combination with elranatamab on T cell response by assessing tumor specific immunity, effector cell phenotype and analysis of T cell receptor (TCR) signature by transcriptomic analysis.
SECONDARY OBJECTIVES:
I. To evaluate the overall survival and progression-free survival of participants treated with combination of DC/MM fusion vaccine and elranatamab.
II. To evaluate the proportion of participants who have complete response (CR or stringent complete response [sCR]) as best response by 1 year after treatment with dendritic cell (DC)/myeloma fusion vaccine.
III. To evaluate the proportion of participants who achieve minimal residual disease (MRD) negative disease at 1 year after treatment with DC/MM fusion cell vaccination.
OUTLINE:
TUMOR COLLECTION: Patients undergo bone marrow aspiration within 1 - 2 weeks after registration prior to DC/MM fusion vaccine for collection of multiple myeloma cells for DC/MM fusion vaccine preparation.
DENDRITIC CELL COLLECTION: Patients undergo leukapheresis within 1 - 2 weeks after registration prior to DC/MM fusion vaccine for collection of peripheral blood mononuclear cells from which dendritic cells will be generated for DC/MM fusion vaccine preparation.
TREATMENT: Patients receive elranatamab subcutaneously (SC) once daily (QD) on days 1, 4, 8, 15 and 22 of cycle 1, days 1, 8, 15 and 22 of cycles 2-6 and days 1 and 15 of cycles 7-12. Patients receive DC/MM fusion vaccine SC QD on day 8 of cycles 3-5. Patients receive granulocyte-macrophage colony-stimulating factor (GM-CSF) SC QD on days 8-11 of cycles 3-5. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
Additionally, patients undergo positron emission tomography (PET)/computed tomography (CT), CT or magnetic resonance imaging (MRI) as well as bone marrow biopsy and aspiration and blood sample collection throughout the study. Patients may optionally undergo biopsy as clinically indicated.
After completion of study treatment, patients are followed up monthly for the first 6 months and then every 3 months for up to 5 years.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorDavid E. Avigan