Phase II Clinical Trial of ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma

Summary

Primary objective: To assess the safety of ITF 2357 administered once weekly at high pulse dose in patients with relapsing/refractory multiple myeloma. Secondary objectives: 1. To evaluate the anti-tumour activity of ITF 2357 administered once weekly at high pulse dose in patients with advanced multiple myeloma, measured as decrease of M protein. 2. To assess the therapeutic response to ITF3257 according to EBMT criteria. 3. To determine pharmacokinetic profile of ITF 2357 administered following high pulse dose schedule.

Timeline

Start

2008-10

Primary completion

2010-01

Completion

2010-07

Drugs

Indications