This phase II trial studies the effect of MGTA-145 when given together with plerixafor in mobilizing stem cells (helping push stem cells out of the bone marrow into the blood) so they can be collected and used for stem cell transplant for the treatment of patients with multiple myeloma. All of the cells of the immune system including red cells, white cells and platelets are made in the bone marrow. All of these cells develop from a type of cell found in the bone marrow called a "hematopoietic stem cell." This is the type of cell collected for blood and marrow transplantation. In order to collect enough hematopoietic stem cells from the bone marrow to make a successful transplant, cells have to be moved from the bone marrow to the blood. Once they are in the blood, they can be collected during a procedure called ‘apheresis’. Currently this requires several days of different medicines (4-5 days) and several days of apheresis. MGTA-145 and plerixafor are drugs that help push stem cells out of the bone marrow into the blood. Giving MGTA-145 together with plerixafor, may allow doctors to collect the necessary number of stem cells for future transplant in less time and with less side effects than the standard mobilization procedure.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04552743.
PRIMARY OBJECTIVE:
I. To assess the efficacy of CXCR2 Agonist MGTA-145 (MGTA-145) in combination with plerixafor in mobilizing adequate number of hematopoietic stem cells (HSCs) in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT).
SECONDARY OBJECTIVES:
I. To assess the efficacy of MGTA-145 in combination with plerixafor in mobilizing different HSCs target goals in patients with MM in preparation for ASCT.
II. To assess the safety and tolerability of MGTA-145 and plerixafor for mobilizing HSCs in patients with MM.
III. To assess the rate and kinetics of engraftment following ASCT after HSC mobilization with MGTA-145 + plerixafor in patients with MM undergoing upfront ASCT.
IV. To assess rate of ongoing engraftment at day 28 and 100 after ASCT with HSCs with MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.
V. To assess transplant and disease-related outcomes after mobilization of HSCs with MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.
EXPLORATORY OBJECTIVES:
I. Assess the composition of the apheresis product with mobilization with MGTA-145 and plerixafor in patients with MM.
II. Assess proliferation and differentiation potential of HSCs collected with MGTA-145 and plerixafor via colony-forming unit assays.
III. To assess immunological recovery in patients with MM undergoing upfront transplantation after infusion of HSCs collected with MGTA-145 and plerixafor mobilization.
IV. To assess patient reported symptoms with stem cell mobilization with MGTA-145 and plerixafor in patients with MM.
OUTLINE:
Patients receive plerixafor subcutaneously (SC) and CXCR2 Agonist MGTA-145 intravenously (IV) over 3-10 minutes and then undergo apheresis on day 1. Patients may receive additional plerixafor SC and CXCR2 Agonist MGTA-145 IV over 3-10 minutes and undergo apheresis on day 2 in the absence of unacceptable toxicity.
After completion of study treatment, patients who are not proceeding with upfront transplant are followed up for 30 days and patients who are proceeding with upfront transplant are followed up for 100 days.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorSurbhi Sidana
