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

NCT04552743 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB-57056BMT362
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests

  The study Primary Objective is to assess the efficacy of hematopoietic stem cells (HSC) mobilization with MGTA-145 in combination with plerixafor in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). The primary outcome was assessed as the number of participants for whom 2.0 x 10e6 CD34+ HSC cells/kg could be collected in 1 or 2 apheresis harvests, after mobilization with MGTA-145 and Plerixafor. The outcome is reported as the number of participants who achieved this level of HSC cells, a number without dispersion.

  2 days

Secondary Outcomes (10)

• Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product

  2 days

• Time To Neutrophil Engraftment

  15 days

• Maintenance of Neutrophil Engraftment [Absolute Neutrophil Count (ANC) ≥ 0.5 x 10e9/L]

  100 days

• Time To Platelet Engraftment ≥ 20 x 10e9/L

  33 days

• Time To Platelet Engraftment ≥ 50 x 10e9/L

  44 days

Study Arms (1)

MGTA-145 and Plerixafor HSC Mobilization

EXPERIMENTAL

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.

Drug: MGTA-145; Drug: Plerixafor

Interventions

MGTA-145 DRUG

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

Also known as: GRO beta

MGTA-145 and Plerixafor HSC Mobilization

Plerixafor 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).

Also known as: Mozobil, AMD 3100, LM-3100

MGTA-145 and Plerixafor HSC Mobilization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Surbhi Sidana, MD: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 39384609 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Chemokine CXCL2; plerixafor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chemokines, CXC; Chemokines; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage Inflammatory Proteins; Proteins; Chemotactic Factors; Biological Factors; Inflammation Mediators

Results Point of Contact

• Title: Khanh Nguyen
• Organization: Stanford Medicine at Stanford University

khanhpn@stanford.edu

650-721-2372

Study Officials

• Surbhi Sidana, MD

  Stanford Medicine at Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 17, 2020
• Study Start: October 5, 2020
• Primary Completion: July 22, 2021
• Study Completion: June 30, 2022
• Last Updated: September 10, 2022
• Results First Posted: September 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)