Bendamustine, Bortezomib (Velcade ®) and Prednisone (BVP) in Patients Newly Diagnosed Multiple Myeloma
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Efficacy in terms of response rate and complete response rate (CR and near CR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Safety in terms of toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Time to progresion [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Progresion free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Global survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376401
|Hospital Germans Trias i Pujol|
|Badalona, Barcelona, Spain|
|Institut català d'Oncología|
|Hospital 12 de Octubre|
|Hospital Clínico San Carlos|
|Hospital Universitario de la Princesa|
|Hospital Universitario Ramón y Cajal|
|MD Anderson Internacional|
|Hospital General Morales Messeguer|
|Hospital Universitario Virgen de la Victoria|
|Hospital Universitario Central de Asturias|
|Hospital Universitario Virgen del Rocío|
|Hospital Universitario La Fe|
|Hospital Clinico Universitario Lozano Blesa|