Personalized Autologous Transplant
Personalized Autologous Transplant for Multiple Myeloma
What will happen during the trial?
PRIMARY OBJECTIVES:
I. Measure achievement of target melphalan systemic exposure in the first 20 patients.
II. Identify safety and preliminary efficacy within each systemic exposure range of melphalan using a 5+5 design.
SECONDARY OBJECTIVES:
I. Describe International Myeloma Working Group response levels and selected grade 3/4 toxicities in an expansion set of patients at the recommended phase 2 area under the curve (AUC) range.
II. Measure deoxyribonucleic acid (DNA) repair score from formalin-fixed paraffin-embedded diagnostic bone marrow sample (FFPE) and from pretransplant marrow aspirate sample.
III. Assess melphalan-induced DNA damage in peripheral blood mononuclear cells (PBMCs) from melphalan-treated patients.
IV. To correlate peripheral blood CMMCs numbers obtained with CELLSEARCH with MRD assessment at day+90.
OUTLINE: This is a dose-escalation study.
Patients receive standard of care high dose melphalan hydrochloride intravenously (IV) over 30 minutes on day -3 and PK-directed melphalan hydrochloride IV over 30 minutes on day -1. Patients then undergo autologous stem cell transplantation (ASCT) on day 0.
After completion of study treatment, patients are followed up at 7, 14, 30, 60, and 90 days.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 1
- Enrollment
- 90 patients (estimated)
- Sponsors
- Winship Cancer Institute
- Collaborators
- National Cancer Institute (NCI), Gateway for Cancer Research
- Tags
- Autologous Stem Cell Transplant, Chemotherapy, Vaccine
- Trial Type
- Treatment
- Last Update
- 1 month ago
- SparkCures ID
- 1129
- NCT Identifier
- NCT04483206
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