Spots Global Cancer Trial Database for Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma

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Trial Identification

Brief Title: Safety, Efficacy and Pharmacokinetic Study of PRLX 93936 in Patients With Multiple Myeloma

Official Title: Phase 1/2, Multi-center, Open Label, Dose Escalation, Safety, Efficacy and PK Study of PRLX 93936 Administered IV 3 Days a Week for 3 Weeks Followed by a 9 Day Rest Period in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Study ID: NCT01695590

Conditions

Multiple Myeloma

Interventions

PRLX 93936

Study Description

Brief Summary: To determine the maximum tolerated dose of, and response to, PRLX 93936 as treatment for patients with relapsed or relapsed/refractory multiple myeloma.

Detailed Description: * To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period, as treatment for patients with relapsed or relapsed/refractory multiple myeloma. * To establish the dose of PRLX 93936 recommended for future studies. * To characterize potential toxicities of PRLX 93936. * To assess the pharmacokinetic profile of PRLX 93936. * To evaluate response to treatment, time to response (TTR) and duration of response. * To evaluate time to progression (TTP).