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

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

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

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