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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete remission after 4 cycles:

Principal Investigator

Jean-Luc HAROUSSEAU, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NANTES UH

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD 03/6-E

NCT ID:

NCT00337506

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • the efficacy and safety of Velcade plus dexamethasone
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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