A phase 1 study of IPI-504 (retaspimycin hydrochloride) in patients with relapsed or relapsed and refractory multiple myeloma

作者：Siegel David^*; Jagannath Sundar; Vesole David H; Borello Ivan; Mazumder Amitabha; Mitsiades Constantine; Goddard Jill; Dunbar Joi; Normant Emmanuel; Adams Julian; Grayzel David; Anderson Kenneth C; Richardson Paul

来源：Leukemia and Lymphoma, 2011, 52(12): 2308-2315.

DOI：10.3109/10428194.2011.600481

• Multiple myeloma
• HSP90
• IPI-504
• phase 1
• relapsed/refractory

A phase 1 study of IPI-504 (retaspimycin hydrochloride) administered intravenously twice weekly for 2 weeks at 22.5, 45, 90, 150, 225, 300 or 400 mg/m(2) followed by 10 days off-treatment was conducted to determine the safety and maximum tolerated dose (MTD) of IPI-504 in patients with relapsed or relapsed/refractory multiple myeloma (MM). Anti-tumor activity and pharmacokinetics were also evaluated. Eighteen patients (mean age 60.5 years; median 9 prior therapies) were enrolled. No dose-limiting toxicities (DLTs) were reported for IPI-504 doses up to 400 mg/m(2). The most common treatment-related adverse event was grade 1 infusion site pain (four patients). All other treatment-related events were assessed as grade 1 or 2 in severity. The area under the curve (AUC) increased with increasing dose, and the mean half-life was approximately 2-4 h for IPI-504 and its metabolites. Four patients had stable disease, demonstrating modest single-agent activity in relapsed or relapsed/refractory MM.

• 出版日期2011-12