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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00337506     History of Changes
Other Study ID Numbers: BRD 03/6-E
Study First Received: June 14, 2006
Last Updated: June 15, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on November 24, 2014