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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337506
First Posted: June 16, 2006
Last Update Posted: June 16, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nantes University Hospital
  Purpose
The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.

Condition Intervention Phase
Multiple Myeloma Drug: Dexamethasone Drug: velcade Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Open-Label Phase II Study of Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 50
Study Start Date: August 2003
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337506


Locations
France
Jean-Luc HAROUSSEAU
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Jean-Luc HAROUSSEAU, MD NANTES UH
  More Information

ClinicalTrials.gov Identifier: NCT00337506     History of Changes
Other Study ID Numbers: BRD 03/6-E
First Submitted: June 14, 2006
First Posted: June 16, 2006
Last Update Posted: June 16, 2006
Last Verified: August 2004

Keywords provided by Nantes University Hospital:
the efficacy and safety of Velcade plus dexamethasone
Multiple Myeloma

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
Bortezomib
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors