Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments velcade-dexamethasone, velcade-thalidomide-dexamethasone
Phase phase 3
Sponsor Intergroupe Francophone du Myelome
Start date March 2008
End date August 2009
Trial size 205 participants
Trial identifier NCT00910897, Eudract 2007-005204-40, IFM 2007-02

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
velcade-dexamethasone
(Active Comparator)
velcade-thalidomide-dexamethasone

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Newly diagnosed symptomatic multiple myeloma (MM) patient - Aged under 65 - Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day) - Using effective contraceptive methods (for fertile men, women of childbearing potential) - Provision of informed consent - No evidence of active infection Exclusion Criteria: - Asymptomatic MM - Non-secretory MM - Aged 66 years or over - ECOG performance status over 2 (see Appendix 2) - Proven amyloidosis - A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer) - Positive HIV serology - A personal medical history of severe psychiatric disease - Severe diabetes contraindicating the use of high-dose dexamethasone - NCI grade ³ 2 peripheral neuropathy - Serum clinical chemistry: - creatinine level > 300 µmol/L or requiring dialysis - bilirubin, transaminases or GamaGT > 3 the upper normal limit (UNL) - Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization) - Radiation therapy in the 2 weeks preceding randomization - A personal medical history of allergic reactions to compounds containing boron or mannitol - Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or NYHA class III or IV renal failure - Use of any investigational drug in the 30 days preceding randomization - Pregnant or lactating women; a serum Beta-hCG pregnancy test must be performed during the screening phase for female patients of childbearing potential - Severe pulmonary troubles (including acute infiltrative pneumopathy)

Additional Information

Official title A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Intergroupe Francophone du Myelome.