Phase 2
Completed N=25
MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
Source: ClinicalTrials.gov NCT04552743 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcomePrimary: Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests — 22 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests |
22 | — |
| SECONDARY Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product |
17; 9; 17; 10 | — |
| SECONDARY Time To Neutrophil Engraftment |
12 | — |
| SECONDARY Maintenance of Neutrophil Engraftment [Absolute Neutrophil Count (ANC) ≥ 0.5 x 10e9/L] |
19; 19 | — |
| SECONDARY Time To Platelet Engraftment ≥ 20 x 10e9/L |
18 | — |
| SECONDARY Time To Platelet Engraftment ≥ 50 x 10e9/L |
20 | — |
| SECONDARY Infusion-related Toxicities |
11; 1; 2; 1; 1; 2 | — |
| SECONDARY Progression-free Survival (PFS) |
18 | — |
| SECONDARY Transplant-related Mortality |
— | — |
| SECONDARY Non-relapse-related Mortality |
— | — |
| SECONDARY Overall Survival (OS) |
19 | — |
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
Data sourced from ClinicalTrials.gov (NCT04552743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.