MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
This research study tests a new medicine for mobilizing stem cells so they can be collected
 and used for autologous stem cell transplant for treatment of multiple myeloma. MGTA-145, the
 new medicine, will be given with plerixafor.
PRIMARY OBJECTIVE(S)

 1. To assess the efficacy of MGTA-145 in combination with plerixafor in mobilizing adequate
 number of hematopoietic stem cells (> 2 x 106 CD34+ cells/kg) in patients with multiple
 myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). SECONDARY
 OBJECTIVE(S)

 1. 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.

 2. To assess the safety and tolerability of MGTA-145 and plerixafor for mobilizing HSCs in
 patients with MM.

 3. 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.

 4. 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.

 5. To assess transplant and disease-related outcomes after mobilization of HSCs with MGTA-
 145 and plerixafor in patients with MM undergoing upfront ASCT.
Inclusion Criteria:

 -  Diagnosis of multiple myeloma per the International Myeloma Working Group (IMWG)
 criteria

 -  Eligible for ASCT per institutional guidelines

 -  Within one year of start of myeloma therapy

 -  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 > 1500 x106/L and platelets > 100,000 x106/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.

 -  Liver function tests: Total bilirubin >1.5x upper limit of normal (ULN) in the absence
 of a documented history of Gilbert's syndrome and/or 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 i.e more than six 28-day cycles or more than eight
 21-day cycles.

 -  Pregnant or lactating women.