Multiple Myeloma Clinical Trial
MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
Summary
This study evaluates a new drug MGTA-145 in combination with plerixafor (Mozobil) to mobilize stem cells into the peripheral blood for collection by apheresis. The stem cells will be used for autologous stem cell transplant for treatment of multiple myeloma.
Full Description
PRIMARY OBJECTIVE
1. To assess the efficacy of MGTA-145 in combination with plerixafor in mobilizing adequate number of hematopoietic stem cells (> 2 x 10e6 CD34+ cells/kg) in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT).
SECONDARY OBJECTIVES
To assess the efficacy of MGTA-145 and plerixafor in mobilizing different Hematopoietic stem cells (HSCs) target goals in patients with MM in preparation for ASCT.
To assess the safety and tolerability of MGTA-145 and plerixafor for mobilizing HSCs in patients with MM.
To assess the engraftment rate and time to engraftment following ASCT after HSC mobilization with MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.
To assess rate of ongoing engraftment at Day 30 and 100 after stem cell infusion in patients with MM who are mobilized with MGTA-145 and plerixafor undergoing upfront ASCT.
To assess transplant and disease-related outcomes after mobilization of HSCs with MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.
Eligibility Criteria
Inclusion Criteria:
Diagnosis of multiple myeloma (MM) per the International Myeloma Working Group (IMWG) criteria
Eligible for autologous stem cell transplantation (ASCT) per institutional guidelines
Within 1 year of start of therapy for multiple myeloma
Cardiac and pulmonary status sufficient to undergo apheresis and transplantation per institutional transplant guidelines
Calculated creatinine clearance > 30 mL/min, according to the Modification of Diet in Renal Disease (MDRD) formula.
Absolute neutrophil count (ANC) > 1500 x 10e6/L
Platelet count > 100,000 x 10e6/L
Ability to understand and the willingness to sign a written informed consent document.
Agreement to use an approved form of contraception for male patients or female patients of childbearing potential.
Exclusion Criteria:
History of prior stem cell transplant for multiple myeloma or other indications
Planned tandem stem cell transplant
Prior history of failure to collect HSCs.
Total bilirubin > 1.5x upper limit of normal (ULN) in the absence of a documented history of Gilbert's syndrome
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 3x ULN
Known allergy to MGTA-145 or plerixafor.
Lifetime exposure to lenalidomide or another immunomodulatory drug greater than 6 cumulative months of treatment, ie, > 6 cycles of 28 days or > 8cycles of 21 days
Pregnant or lactating
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Stanford California, 94304, United States
How clear is this clinincal trial information?