Study of Induction Treatment With Velcade and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure

• Status: Completed
• Trial end date: 2013-12-01

Summary

Primary outcome measure:

• Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment

Secondary outcome measures:

• Study the speed of response and the response rate (M component in serum and urine protein) after each bortezomib/dexamethasone cycle

• Compare the efficacy of the bortezomib/dexamethasone therapy against the therapy without bortezomib

• Reversibility of renal failure

• Predictive value in the light chain determination for response and reversibility of renal failure

• Early morbidity (< 2 months)

• Progression-free survival

• Overall survival

The safety outcome consists in:

• Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity criteria of clinical and laboratory events

• Phase: Phase 2

Details

• Lead Sponsor: PETHEMA Foundation
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate