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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