NCT00920855

Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

An Open-Label Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cephalon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (MM).

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	bendamustine	Bendamustine was administered to 3 cohorts of patients at escalating doses of 50 (cohort 1), 70 (cohort 2) and 90 mg/m\^2/dose (cohort 3). Doses were administered by intravenous (iv) infusion once daily on days 1 and 4 of each 28-day cycle. Each iv was administered over 60 minutes and followed the injection of bortezomib. Bortezomib will be administered to patients at a dose of 1.0 mg/m2/dose as an iv push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered to patients on days 1, 4, 8 and 11 of the 28-day cycle.
DRUG	bortezomib	Bortezomib was administered at a dose of 1.0 mg/m\^2/dose as an intravenous (iv) push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered on days 1, 4, 8 and 11 of each 28-day cycle.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-07-01
• Completion: 2011-12-01
• First posted: 2009-06-15
• Last updated: 2012-10-04
• Results posted: 2012-09-17

Locations

13 sites across 1 country: United States