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Trial record 12 of 44 for:    magenta

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

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ClinicalTrials.gov Identifier: NCT04552743
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: MGTA-145 Drug: Plerixafor Phase 2

Detailed Description:

PRIMARY OBJECTIVE(S)

1. To assess the efficacy of MGTA-145 in combination with plerixafor in mobilizing adequate number of hematopoietic stem cells (> 2 x 106 CD34+ cells/kg) in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). SECONDARY OBJECTIVE(S)

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Plerixafor

Arm Intervention/treatment
Experimental: 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.
Drug: MGTA-145
MGTA-145 investigational agent will be provided by Magenta Therapeutics. MGTA-145 will be administered as an IV infusion over 3 to10 minutes, as clinically indicated.

Drug: Plerixafor
Plerixafor (0.24 mg/kg) will be administered subcutaneously. Plerixafor dose will be reduced to 0.16 mg/kg in patients with renal dysfunction per package insert
Other Names:
  • Mozobil
  • AMD 3100
  • LM-3100




Primary Outcome Measures :
  1. HSC yield in apheresis product [ Time Frame: 2 days of stem cell mobilization and apheresis ]
    The primary outcome is collection of 2.0 x 106 CD34 cells/kg in one or two days of apheresis after mobilization with MGTA-145 and plerixafor. CD34 yield of collected HSCs expressed as CD34+ cells/kg of patient body weight.


Secondary Outcome Measures :
  1. Infusion related toxicities with MGTA-145 [ Time Frame: 7 days after mobilization ]
    Adverse events will be collected based on NCI CTCAE version 5 with mobilization of HSCs with MGTA-145 and plerixafor.

  2. Neutrophil engraftment [ Time Frame: 48 hours ]

    Only patients proceeding with upfront transplant will be assessed. Time to primary engraftment is defined as time in days from the day of stem cell infusion to the first day of engraftment.

    Neutrophil engraftment is defined as the first day of Absolute neutrophil count (ANC) ≥0.5 x 109/L for 3 days following stem cell infusion. This is assessed by absolute neutrophil counts obtained as part of complete blood count (CBC) with differential. It is standard practice to follow patients regularly in the inpatient unit/outpatient transplant unit until they achieve engraftment.


  3. Platelet engraftment [ Time Frame: 48 hours ]

    Only patients proceeding with upfront transplant will be assessed. Time to primary engraftment is defined as time in days from the day of stem cell infusion to the first day of engraftment.

    • Platelet engraftment is defined as the first day of platelet count more than or equal to 20 x 109/L without transfusion in the last 7 days and with platelet count ≥20 x 109/L on 2 separate, subsequent days. This is assessed by platelets counts obtained as part of CBC with differential. It is standard practice to follow patients regularly in the transplant inpatient unit/outpatient transplant until they achieve engraftment.


  4. Transplant related mortality [ Time Frame: 100 days ]
    Only patients proceeding with upfront transplant will be assessed. Transplant related mortality is described as death from any cause within the first 100 days of HSC infusion.

  5. Non-relapse related mortality [ Time Frame: 100 days ]
    Only patients proceeding with upfront transplant will be assessed. Transplant related non-relapse mortality is described as death from any cause except disease relapse/progression within the first 100 days of HSC infusion.

  6. Progression Free Survival (PFS) [ Time Frame: 100 days after transplant ]
    Only patients proceeding with upfront transplant will be assessed. Duration from start of the ASCT to disease progression or death (regardless of cause of death), whichever comes first. Progression will be assessed using day 100 post-transplant response and PFS rates will be reported at day 100 in patients undergoing upfront transplant.

  7. Overall Survival (OS) [ Time Frame: 100 days after transplant ]
    Only patients proceeding with upfront transplant will be assessed. Overall survival is defined as duration from start of the ASCT to death (regardless of cause of death). This will be assessed from start of transplant and OS rates will be reported at day100 following transplant in patients undergoing upfront transplant.

  8. Response Assessment [ Time Frame: 100 days ]
    Response before mobilization will be assessed in all patients. Response/progression following transplant will be assessed in patients undergoing upfront transplant. Myeloma response before stem cell mobilization and at day 100 will be assessed per the International Myeloma Working Group Uniform Response Criteria.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552743


Contacts
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Contact: Khanh Nguyen 650-721-2372 khanhpn@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Khanh Nguyen    650-721-2372    khanhpn@stanford.edu   
Principal Investigator: Surbhi Sidana, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Surbhi Sidana, MD Stanford University
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04552743    
Other Study ID Numbers: IRB-57056
BMT362 ( Other Identifier: OnCore )
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Plerixafor octahydrochloride
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents