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Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)

NCT00910897 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2009-06-01

No results posted yet for this study

Summary

Primary objective:

* Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD.

Secondary objectives:

* Compare the following parameters following 4 cycles of VD or VTD induction treatment:

* CR rate+ very good partial remission (VGPR) rate
* Overall remission rate (CR + VGPR + partial remission (PR) rate)
* K/l light chain ratio in patients in CR.
* Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization).
* Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).

Conditions

Interventions

DRUG

Velcade-Dexamethasone

DRUG

Velcade-Thalidomide-Dexamethasone

Sponsors & Collaborators

  • Intergroupe Francophone du Myelome

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-08-31

Countries

  • Belgium
  • France

Study Locations

More Related Trials

Entities

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 NCT00910897 on ClinicalTrials.gov