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

Surbhi Sidana, MD

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Plerixafor; Drug: MGTA-145

Study type: Interventional

Funder types: Other

Identifiers

NCT04552743

BMT362 (Other Identifier)

IRB-57056

Details and patient eligibility

About

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

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

MGTA-145 and Plerixafor HSC Mobilization

Experimental group

Description:

Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session.

Treatment:

Drug: MGTA-145

Drug: Plerixafor