Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma
This is a Phase I/IIa clinical trial to identify the maximum tolerated dose of atiprimod and to evaluate the safety of atiprimod in patients with refractory or relapsed multiple myeloma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma|
- The primary objective of this study is to identify the maximum tolerated dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- The secondary objective of this study is to measure the pharmacokinetics of [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2004|
|Study Completion Date:||November 2007|
This is a multi-center, open-label, dose escalation study intended to identify the MTD of atiprimod alone and the MTD of atiprimod when given in combination with ursodiol. The atiprimod dose will be escalated in sequential cohorts. Ten dose levels of atiprimod are planned for the atiprimod alone dose escalation: 30, 60, 90, 120, 180, 240, 300, 360, 420, and 480 mg/day to be given orally. Six dose levels of atiprimod are planned for the atiprimod in combination with ursodiol dose escalation: 180, 240, 300, 360, 420, and 480 mg/day to be given orally. The dose of ursodiol will remain constant for all cohorts (300 mg ursodiol orally three times a day everyday). Up to 105 patients will participate depending on the level at which toxicity is observed. Patients will be assigned to dose level in the order of study entry.