NCT00765102

Trial of Romidepsin and Bortezomib for Multiple Myeloma

A Phase II Trial of Romidepsin and Bortezomib for Multiple Myeloma Patients With Relapsed or Refractory Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-label, multicenter, dual-strata study designed to evaluate the efficacy and safety of IV romidepsin given in combination with IV bortezomib for multiple myeloma (MM) patients with refractory or relapsed disease. Patients will be enrolled into one of two strata, bortezomib-resistant or bortezomib non-resistant.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib was administered at a dose of 1.0 mg/m\^2 as an intravenous (IV) push over 3 to 5 seconds twice weekly for 2 consecutive weeks (Days 1, 4, 8 and 11) of each 28-day cycle. On days that bortezomib and romidepsin were administered together, bortezomib was administered prior to the romidepsin infusion. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
DRUG	Romidepsin	Romidepsin initially was administered at a dose of 10 mg/m\^2 as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle. Based on the occurrence of Grade 3 thrombocytopenia at this dose level, the dose was reduced by protocol amendment to 8 mg/m\^2.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-10-02
• Last updated: 2019-11-25
• Results posted: 2012-12-20

Locations

12 sites across 1 country: United States