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

Phase 2

Terminated

• Conditions: Multiple Myeloma

• Registration Number: NCT00337506
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Status Verified: 2004-08
• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-15
• Last Update Submitted: 2006-06-15
• Study First Posted: 2006-06-16
• Last Update Posted: 2006-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jean-Luc HAROUSSEAU; 🇫🇷 Nantes, France