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:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200681
First received: September 12, 2005
Last updated: February 4, 2009
Last verified: February 2009
  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:


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)
Detailed Description:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014