IFM 2005-01: Velcade/Dexamethasone Versus Vincristine/Adriamycin (Doxorubicin)/Dexamethasone (VAD) for the Treatment of Patients With Multiple Myeloma
This study has been completed.
Sponsor:
Nantes University Hospital
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200681
First received: September 12, 2005
Last updated: February 4, 2009
Last verified: February 2009
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Purpose
This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by autograft as first-line therapy, as the investigators try to compare the complete remission (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Velcade |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Etude Multicentrique Ouverte Randomisée de Phase III Comparant l'Association de VELCADE®-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusqu'à l'âge de 65 Ans |
Resource links provided by NLM:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Bortezomib
U.S. FDA Resources
Further study details as provided by Nantes University Hospital:
Primary Outcome Measures:
- To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment
| Enrollment: | 493 |
| Study Start Date: | June 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
After their written informed consent has been obtained and their eligibility verified, patients are randomised between 4 treatment arms: A1 VAD (4 cycles); A2 VAD (4 cycles) followed by DCEP (2 cycles); B1 Velcade® + dexamethasone (4 cycles); B2 Velcade® + dexamethasone (4 cycles) followed by DCEP (2 cycles) A1, A2, B1, B2 + autograft. Randomisation will be stratified on the basis of the initial b2 microglobulin level (> or < 3 mg/l) and the presence of chromosome 13 abnormalities identified by FISH analysis. VAD: Vincristine/Adriamycin/Dexamethasone; DCEP: Dexamethasone/Cyclophosphamide/ Etoposide/Cisplatin.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Recently diagnosed MM according to the criteria of the South West Oncology Group (SWOG)
- Not previously treated, apart from local radiotherapy, in the case of a threatening or incapacitating lesion, and/or a 4-day block of dexamethasone (40 mg/mL) in an emergency
- Stage II or III disease according to the Durie and Salmon classification or Stage I disease with symptomatic bone lesion
- < 65 years of age
- Ability to give signed informed consent
- Secretion of a measurable monoclonal spike (> 10 g/l in the serum or 0.2 g/24h in the urine)
- Negative pregnancy test at inclusion (if necessary)
- Absence of active infection. In the case of infection, appropriate antibiotic therapy must be administered and patients must have been apyretic for 48 hours before the start of treatment with VAD or Velcade®/dexamethasone
Exclusion Criteria:
- ECOG performance status > 2
- History of cancer (other than basal cell carcinoma or carcinoma of the cervix in situ)
- Life expectancy < 2 months
- Confirmed amyloidosis
- Positive HIV serology
- Serious psychiatric item in the history
- Renal failure requiring dialysis
- Uncontrolled diabetes, contra-indicating the use of corticosteroids
- Peripheral neuropathy National Cancer Institute (NCI) grade > 2 (Annex 5)
- Clinical signs of heart failure or coronary heart disease
- Bilirubin > 3 x normal
- Transaminases or gamma-glutamyl transpeptidase (GT) > 4 x normal
- Platelets < 50 x 10^9/l during the 15 days prior to inclusion
- Neutrophils < 0.75 x 10^9/l during the 15 days prior to inclusion
- Use of an investigational medicinal product during the 30 days prior to inclusion
- Known hypersensitivity to bortezomib, boron or mannitol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00200681
Locations
| France | |
| CHU de Nantes, Service d'Hématologie | |
| Nantes, France, 44093 | |
Sponsors and Collaborators
Nantes University Hospital
Investigators
| Principal Investigator: | Jean-Luc Harousseau, MD PHD | Intergroupe Francophone du Myélome (IFM) |
More Information
No publications provided by Nantes University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00200681 History of Changes |
| Other Study ID Numbers: | BRD 04/11-J |
| Study First Received: | September 12, 2005 |
| Last Updated: | February 4, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Nantes University Hospital:
|
Secretory Multiple Myeloma First line treatment Velcade® autograft Newly diagnosed secretory Multiple Myeloma (MM) |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Bortezomib BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 23, 2013