Multiple Myeloma
Conditions
Interventions
Trade Name: Bortezomib (Velcade)
Product Name: Bortezomib
Pharmaceutical Form: Powder for solution for infusion
Trade Name: Melphalan (Alkéran)
Sponsors
CHU Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years and = 65 years - 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 criteria of the International Working Group plasma cell dyscrasias (Leukemia 2009) 2- Symptomatic de novo Multiple Myeloma with myeloma-related organ damage according to the CRAB criteria 3-Measurable disease requiring systemic treatment defined by a serum monoclonal protein = 5 g / l, urinary monoclonal protein = 200 mg/24 h or serum free light chains = 100 mg / l - Be eligible for high-dose therapy with autologous stem cell transplantation. - Autologous cell graft with a total number of CD 34 cells = 5 X 106/kg before freezing. A minimum of 2 x 106 CD34/kg is required - LVEF > 40 % - DLCO >50 %. - ECOG performance status =2 - ALT = 3.5 times upper limit of normal and direct bilirubin = 2 mg / dL (34 µmol / L) within 14 days before enrollment - eGFR = 40 mL / minute within 7 days prior to enrollment; MDRD formula should be used to calculate the creatinine clearance: http://mdrd.com/ - Voluntary written informed consent - Women of childbearing potential must have a negative pregnancy test (serum or urine) before treatment start. They should take effective and acceptable method of contraception before treatment start, during treatment phase and up to 4 weeks after the last treatment administration. Women must also agree to perform iterative pregnancy tests during treatment. - Men must agree not to conceive a child and agree to use a latex condom during the duration of treatment and for 4 weeks after the last treatment administration, even if they have undergone a successful vasectomy if their partner is of childbearing potential. - Participants with social security insurance or equivalent social protection. 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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 - Known allergy to any of the study drugs, their analogs, or their excipients in their various formulations - Known allergy to corticosteroids - A contraindication to one drug or a required concomitant medication, including hypersensitivity to all anticoagulation and / or antiplatelet drugs, antiviral drugs - Any other clinically significant disease that, in the opinion of the investigator, may interfere with adherence to the protocol or the patient's ability to give informed consent. -Participant under juridical protection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the Complete Response rates (according to IMWG 2011 criteria) 60 days post ASCT conditioned with bortezomib-melphalan versus melphalan alone (before consolidation therapy).; Secondary Objective: To compare response rates after ASCT and after the completion of consolidation therapy between the two arms To compare the safety profile of bortezomib-melphalan versus melphalan alone To compare progression-free survival between the two arms To compare overall survival between the two arms. ;Primary end point(s): Complete Response rates at day 60 (a window of +15 days is allowed) post PBSC infusion according to IMWG 2011 response criteria. Responses will be reviewed by an experienced reviewer blinded to the treatment assignment.;Timepoint(s) of evaluation of this end point: At day 60 (a window of +15 days is allowed) post PBSC infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: -1: post PBSC infusion and at the completion of consolidation -2: throughout the duration of treatment for patients and up to 60 days after the last dose of study treatment -3: NA ; Secondary end point(s): - Response rates (sCR, CR, VGPR, PR, SD) at day 60 post PBSC infusion and at the completion of consolidation according to IMWG 2011 criteria (with responses review process). Toxicities according to NCI CTCAE v4. Progression-free survival (PFS) and overall survival (OS). PFS is defined as the time from randomization to the disease progression or death for any cause. | — |
Countries
Belgium, France
Contacts
Public ContactHUGUET
CHU Toulouse
Outcome results
None listed