MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: National Institutes of Health (NIH)
• Treatments: Plerixafor; Plerixafor octahydrochloride

Criteria

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.