Clinical trial · Interventional
MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma
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
NCT04552743CI-TRIAL-00060793completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MGTA-145 | Drug | — | UNRESOLVED |
| Plerixafor | Drug | Plerixafor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MGTA-145 and Plerixafor HSC Mobilization
- 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.
- interventionNames
- Drug: MGTA-145
- Drug: Plerixafor
Primary outcomes (1)
- measure
- Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests
- timeFrame
- 2 days
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSidana 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