Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

This study has been terminated.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00337506
First received: June 14, 2006
Last updated: June 15, 2006
Last verified: August 2004

June 14, 2006
June 15, 2006
August 2003
Not Provided
  • Complete remission after 4 cycles:
  • disappearance of serum and/or urine M-component (confirmed by immunofixation)
  • < 5% plasma cells in the bone marrow resolution of all extra-osseous plasmacytomas
  • no evidence of bone progression
Same as current
Complete list of historical versions of study NCT00337506 on ClinicalTrials.gov Archive Site
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Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
A Multicenter Open-Label Phase II Study of Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: Dexamethasone
  • Drug: velcade
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
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Inclusion Criteria:

  • diagnosis of MM according to the SWOG criteria (annex 1)
  • previously untreated (localized radiotherapy is allowed)
  • symptomatic MM stage II or III according to Durie-Salmon staging system (annex 2) or stage I with one symptomatic osteolytic lesion
  • with measurable levels of paraprotein in the serum (> 1g/dl) or in the urine (> 0.2g/24h)
  • age < 75 years
  • able to understand and to given an informed consent
  • male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures.
  • no active systemic infection. In the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. Patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with Velcade plus dexamethasone.

Exclusion Criteria:

  • life expectancy < 2 months
  • ECOG performance status > 2 (annex 3)
  • proven amyloidosis
  • positive HIV serology
  • antecedents of severe psychiatric disease
  • severe diabetes contraindicating the use of high-dose corticoïds
  • > NCI grade 2 peripheral neuropathy (Annex IV)
  • serum biochemical values as follow

    • creatinin level > 200mmol/l
    • bilirubin, transaminases or gGT > 3 the upper normal limit
  • use of any experimental drugs within 30 days of baseline
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00337506
BRD 03/6-E
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Nantes University Hospital
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Principal Investigator: Jean-Luc HAROUSSEAU, MD NANTES UH
Nantes University Hospital
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP