NCT01084837

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

A National, Multicentric, Open-label Study of Induction Treatment With VELCADE and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

60 patients, 18 years or older, diagnosed with newly symptomatic multiple myeloma (standard diagnosis criteria) and renal failure, previously untreated with chemotherapy, will be included. It is an multi centric, national and open study designed in order to determine efficacy of the combination of bortezomib and dexamethasone for multiple myeloma patients with renal failure. The trial consists of two parts: pre-treatment and treatment. Pre- treatment phase: include the enrolment visit in order to determine that the patient is eligible to participate in a study. The patient will be given the Informed Consent Form in order to participate in the study, and detailed information about the treatment, its benefits and risks. Treatment phase: include the treatment which consist of, at the most, 12 cycles of Velcade and Dexamethasone (induction and extension). During these periods, patients will come to the centre for the study visits to be evaluated, the days they will receive Velcade® of each cycle. Once the clinical trial has finished, patients will be monitored during short and long-term periods where progression free survival and overall survival will be evaluated.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	velcade	INDUCTIoN (Cycles 1-4) * Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment * Dexamethasone 40 mg/p.o. days 1-4 and 9-12 cycles 1-4 (Cycles of 21 days) For patients wich is not planned autotransplantation, add: Cycles 5-8 * Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment * Dexamethasone 40 mg/v.o. days 1-4 (Cycles of 21 days) EXTENSION TREATMENT(Cycles 9-12) * Bortezomib 1,3 mg/m2 i.v. days 1, 8, 15 and 22 * Dexamethasone 40 mg/d v.o. days 1-4 (Every 6 weeks)

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-09-01
• Completion: 2013-12-01
• First posted: 2010-03-11
• Last updated: 2015-09-17

Locations

11 sites across 1 country: Spain