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

NCT ID: NCT04552743

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2022-06-30

Brief 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.

Detailed 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MGTA-145 and Plerixafor HSC Mobilization

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.

Group Type: EXPERIMENTAL

MGTA-145

Intervention Type: DRUG

A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes.

Plerixafor

Intervention Type: DRUG

An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).

Interventions

MGTA-145

A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes.

Intervention Type: DRUG

Plerixafor

An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).

Intervention Type: DRUG

Other Intervention Names

GRO beta; Mozobil; AMD 3100; LM-3100

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Surbhi Sidana, MD

OTHER

Sponsor Role: lead

Responsible Party

Surbhi Sidana, MD

Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Surbhi Sidana, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Medicine at Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

Sidana S, Bankova AK, Hosoya H, Kumar SK, Holmes TH, Tamaresis J, Le A, Muffly LS, Maysel-Auslender S, Johnston L, Arai S, Lowsky R, Meyer E, Rezvani A, Weng WK, Frank MJ, Shiraz P, Maecker HT, Lu Y, Miklos DB, Shizuru JA. Phase II study of novel CXCR2 agonist and Plerixafor for rapid stem cell mobilization in patients with multiple myeloma. Blood Cancer J. 2024 Oct 9;14(1):173. doi: 10.1038/s41408-024-01152-1.

Reference Type: DERIVED

PMID: 39384609 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

BMT362

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-57056

Identifier Type: -

Identifier Source: org_study_id