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

NCT00337506 | Terminated Phase 2

• 1 other identifier: BRD 03/6-E
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

the efficacy and safety of Velcade plus dexamethasone; Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Dexamethasone DRUG

velcade DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Jean-Luc HAROUSSEAU

Nantes, 44093, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jean-Luc HAROUSSEAU, MD

  NANTES UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 16, 2006
• Study Start: August 1, 2003
• Last Updated: June 16, 2006

Record last verified: 2004-08

Locations

FR (1)