MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
Trial ID or NCT#
NCT04552743
Status
NOT RECRUITING
Purpose
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.
Official Title
Phase II Study of MGTA-145 in Combination With Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Patients With Multiple Myeloma
Eligibility Criteria
Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
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
Investigator(s)
Surbhi Sidana, MD
Blood and marrow transplant specialist,
Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Contact us to find out if this trial is right for you.
Contact
Khanh Nguyen
650-721-2372
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