Multiple Myeloma
Conditions
Brief summary
Phase III multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy.
Interventions
DRUGBortezomib-Melphalan
Bortezomib will be administered on days: -6, -3, +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.
DRUGMelphalan
Melphalan will be administered on day -2. The PBSC will be injected on day 0.
Sponsors
Ministry of Health, France
Janssen, LP
University Hospital, Toulouse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must have results from their initial diagnosis available at the time of screening to confirm all the following : 1. Diagnosis of multiple myeloma according to the diagnostic 2. Symptomatic de novo Multiple Myeloma * Be eligible for high-dose therapy with autologous stem cell transplantation * Autologous cell graft with a total number of CD 34 cells \> or = 5 X 106/kg before freezing
Exclusion criteria
* Progressive disease * Females participants pregnant or breast-feeding * A known infection by the human immunodeficiency virus * An active viral hepatitis B or C * Unstable angina or myocardial infarction within 4 months prior to inclusion, heart failure NYHA class III or IV angina, uncontrolled, history of severe coronary artery disease, an uncontrolled serious ventricular arrhythmia, a sick sinus syndrome, or electrocardiographic evidence of acute ischemia or conduction disturbances grade 3 unless the patient has a pacemaker * Uncontrolled hypertension or uncontrolled diabetes within 14 days before enrollment * A history of another malignancy. If cancer was diagnosed more than 10 years and considered as cured, an authorization may be requested on a case-by-case basis after discussion with the principal investigator * A significant neuropathy of grade 3-4 or grade 2 with pain in the 14 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response rates (according to IMWG 2011 criteria) | 60 days post Autologous Stem Cells Transplantation |
| overall survival | 60 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rates (according to IMWG 2011 criteria) | post ASCT and consolidation therapy | Compare response rate after ASCT and after the completion of consolidation therapy |
| Serious adverse event | End of study | — |
| progression-free survival between the two arms | 60 months | — |
Countries
Belgium, France
Outcome results
None listed