Spots Global Cancer Trial Database for ATRA, Celecoxib, and Itraconazole as Maintenance

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Trial Identification

Brief Title: ATRA, Celecoxib, and Itraconazole as Maintenance

Official Title: An Open-Label Phase I Trial to Evaluate the Safety and Tolerability of ATRA, Celecoxib, and Itraconazole Administered As Maintenance Treatment Post-Autologous Transplantation in Relapsed Multiple Myeloma

Study ID: NCT02401295

Conditions

Relapsed Multiple Myeloma

Interventions

ATRA

Celecoxib

Itraconazole

Study Description

Brief Summary: The purpose of this study is to evaluate the safety and tolerability associated with the combination of ATRA/celecoxib/itraconazole as maintenance therapy given after an autologous stem cell transplant in relapsed multiple myeloma patients.

Detailed Description: Primary objective: To evaluate safety and tolerability associated with the combination of ATRA/ celecoxib/itraconazole given after a salvage transplant for relapsed myeloma in 25 patients in a cycle schedule consisting of three weeks of treatment followed by a rest period of two weeks for a total of five cycles. Subjects will be evaluable only if they have received at least one dose of maintenance treatment. The salvage transplant is not part of this study. Secondary objective: To explore changes in frequency and molecular signature in the multiple myeloma stem cell (MMSC) fraction based on flow-cytometric assays and gene expression profiling before and after the experimental treatment and to correlate outcome with expression levels of RARα2 at time of relapse.