NCT01376401

Bendamustine, Bortezomib (Velcade ®) and Prednisone (BVP) in Patients Newly Diagnosed Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone (BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease progression or unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible for autologous transplant receive four cycles of BVP, hematopoietic stem cell collection and administration of two cycles BVP over followed by autologous transplant. In addition to the overall response rates, will also be analyzed time to progression (TTP), progression-free survival (PFS) and overall survival. Finally, the results will be compared with BVP with those obtained in 120 patients included in our protocol VMP GEM10MAS65. Patients will be evaluated at scheduled visits up to 3 periods of study: pretreatment, treatment and monitoring.

Detailed description

Patients included in the study will receive a 6 week cycle consisting of Bendamustine administered IV at doses of 90 mg/m2 on days 1 and 4 of the first cycle and days 1 and 8 in subsequent cycles in combination with Bortezomib as a bolus dose of 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29 and 32, and oral prednisone at doses of 60 mg/m2, during the first four days of each cycle. Then, patients will receive eight additional cycles of 5-week . The same pattern consisting of bendamustine and prednisone but bortezomib is administered as an intravenous bolus dose of 1.3 mg/m2 on days 1, 8, 15 and 22.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bendamustine
DRUG	Velcade
DRUG	Prednisone

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-06-01
• Completion: 2015-12-01
• First posted: 2011-06-20
• Last updated: 2016-05-17

Locations

14 sites across 1 country: Spain