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

Multiple Myeloma Clinical Trial

Official title:

A Multicenter Open-Label Phase II Study of Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00337506
• Other study ID #: BRD 03/6-E
• Status: Terminated
• Phase: Phase 2
• First received: June 14, 2006
• Last updated: June 15, 2006
• Start date: August 2003

Study information

• Verified date: August 2004
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Dexamethasone

• velcade

Locations

Country	Name	City	State
France	Jean-Luc HAROUSSEAU	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission after 4 cycles:
Primary	disappearance of serum and/or urine M-component (confirmed by immunofixation)
Primary	< 5% plasma cells in the bone marrow resolution of all extra-osseous plasmacytomas
Primary	no evidence of bone progression