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

NCT01084837 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-09-17

No results posted yet for this study

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

Conditions

Interventions

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)

Sponsors & Collaborators

  • PETHEMA Foundation

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-09-30
Completion
2013-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084837 on ClinicalTrials.gov