Personalized Autologous Transplant for Multiple Myeloma

Summary

Participation Requirements

Description

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 ...

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. 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.

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