NCT04552743 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2022-09-10

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Time To Neutrophil Engraftment

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outcome · POSTED

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

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outcome · POSTED

Time To Platelet Engraftment ≥ 20 x 10e9/L

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outcome · POSTED

Time To Platelet Engraftment ≥ 50 x 10e9/L

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outcome · POSTED

Infusion-related Toxicities

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Transplant-related Mortality

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outcome · POSTED

Non-relapse-related Mortality

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outcome · POSTED

Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
maximum Age: 70 Years
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: MGTA-145
Drug: Plerixafor
label
MGTA-145 and Plerixafor HSC Mobilization
type
EXPERIMENTAL

interventions

arm Group Labels
MGTA-145 and Plerixafor HSC Mobilization
description
A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes.
name
MGTA-145
other Names
GRO beta
type
DRUG
arm Group Labels
MGTA-145 and Plerixafor HSC Mobilization
description
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).
name
Plerixafor
other Names
Mozobil
AMD 3100
LM-3100
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 25
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests
time Frame
2 days

secondary Outcomes

description
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). Other secondary outcomes were assessed as the number of participants for whom 2.0 or 4.0 x 10e6 CD34+ HSC cells/kg could be collected in the Day 1 apheresis harvest only, and for whom the total yield ≥ 4.0 or ≥ 6.0 x 106 CD34+ cells/kg. The outcome is reported as the number of participants who achieved these levels of HSC cells, a number without dispersion.
measure
Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product
time Frame
2 days
description
Neutrophil engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to neutrophil engraftment is defined as the number of days from the day of stem cell infusion to the 1st day of 3 consecutive days that absolute neutrophil count (ANC) is ≥ 0.5 x 10e9/L. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days with full range.
measure
Time To Neutrophil Engraftment
time Frame
15 days
description
Maintenance of successful engraftment after initial engraftment is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants with successful neutrophil engraftment \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\], the outcome is reported as the number of participants that had maintained successful graft status \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\] at 30 days and 100 days after the infusion. The outcome is a number without dispersion.
measure
Maintenance of Neutrophil Engraftment [Absolute Neutrophil Count (ANC) ≥ 0.5 x 10e9/L]
time Frame
100 days
description
Platelet engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to platelet engraftment ≥ 20 x 10e9/L is defined as the 1st day of 2 consecutive days that platelet count is ≥ 20 x 10e9/L, without transfusion in the prior 7 days. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days with full range.
measure
Time To Platelet Engraftment ≥ 20 x 10e9/L
time Frame
33 days
description
Platelet engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to platelet engraftment ≥ 50 x 10e9/L s defined as the 1st day that platelet count is ≥ 50 x 10e9/L, without transfusion in the prior 48 hours. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days, with full range.
measure
Time To Platelet Engraftment ≥ 50 x 10e9/L
time Frame
44 days
description
Infusion-related toxicities are adverse events considered at least possibly-related to the study treatments MGTA-145, assessed from Baseline to 7 days after mobilization. The outcome is reported as a listing of the preferred terms for the "at least possibly-related" adverse events, with outcome being the number of adverse events of that preferred term. The outcome is a listing of numbers without dispersion.
measure
Infusion-related Toxicities
time Frame
7 days after mobilization procedure
description
Progression-free survival (PFS) is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who remained alive and were without tumor progression, at 100 days after the infusion. The outcome is a number without dispersion.
measure
Progression-free Survival (PFS)
time Frame
100 days after infusion procedure
description
Transplant-related mortality is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who had expired for any reason considered at least possibly related to the transplant / infusion procedure, within 100 days of the infusion. The outcome is a number without dispersion.
measure
Transplant-related Mortality
time Frame
100 days after infusion procedure
description
For participants that received the HSC infusion, the outcome is reported as the number of participants who had expired for any reason except disease relapse/progression, within 100 days of the infusion. The outcome is a number without dispersion.
measure
Non-relapse-related Mortality
time Frame
100 days after infusion procedure
description
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. Overall survival (OS) is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who remained alive at 100 days after the infusion. The outcome is a number without dispersion.
measure
Overall Survival (OS)
time Frame
100 days after infusion procedure

Full study description

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.

Source references

references

citation
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
type
DERIVED

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice