PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA, UNDER THE AGE OF 66, CANDIDATE FOR AUTOLOGOUS STEM CELL TRANSPLANTATION MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: VELCADE
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Bortezomib
CAS Number: 179324-69-7
Other descriptive name: Velcade
Concentration unit: mg mi
Sponsors
Intergroupe Francophone du Myélome
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Newly diagnosed multiple myeloma (MM) patient - Adult under the age of 66 - Candidate for ASCT, with measurable levels of paraprotein in the serum (>or= to 10 g/L) or the urine (>or= 200mg/day) - Using effective contraceptive methods (for fertile men, women of childbearing potential) - Provision of informed consent - No evidence of active infection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Asymptomatic MM (Multiple Myeloma) - Non-secretory MM. - Over the age of 65 - ECOG performance status over 2 (see Appendix 2) - Proven amyloidosis - A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer) - Positive HIV serology - A personal medical history of severe psychiatric disease - Severe diabetes contraindicating the use of high-dose dexamethasone - NCI grade ³ 2 peripheral neuropathy - Serum clinical chemistry: creatinine level > 300 µmol/L or requiring dialysis & bilirubin, transaminases or ?GT > 3 the upper normal limit (UNL) - Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization) - Radiation therapy in the 2 weeks preceding randomization - A personal medical history of allergic reactions to compounds containing boron or mannitol - Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or NYHA class III or IV renal failure. - Use of any investigational drug in the 30 days preceding randomization - Pregnant or lactating women. A serum beta-hCG pregnancy test must be performed during the screening phase for female patients of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the complete remission (CR) rates (i.e. the true CR, with negative immunofixation) achieved with either four courses of VD (Velcade-Dexamethasone) or four courses of VTD (Velcade-Thalidomide-Dexamethasone);Secondary Objective: •Compare the following parameters following 4 cycles of VD or VTD induction treatment: - CR rate+ very good partial remission (VGPR) rate - Overall remission rate (CR + VGPR + partial remission (PR) rate) - K/l light chain ratio in patients in CR. - Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity, length of hospitalization). •Compare the CR rate and the CR + VGPR rates after post-induction ASCT ;Primary end point(s): to compare the complete remission (CR) rates (i.e. the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD | — |
Countries
Belgium, France
Outcome results
None listed