A study of Bortezomib-Melphalan 200 conditioning regimen versus Melphalan 200 for frontline transplant eligible patients with multiple myeloma
- Conditions
- Multiple MyelomaTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2014-000634-34-BE
- Lead Sponsor
- CHU Toulouse
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 300
- Age = 18 years and = 65 years at the time of induction therapy start
- Must have results from their initial multiple myeloma 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
Must have had induction chemotherapy (at the discretion of clinical physician but preferably by 4 cycles of VTD or VCD) with a maximum of 5 cycles. Induction performed with combined induction therapy (e.g use of VTD followed by VRD) will not be authorized if induction treatment switch is due to patient non-response or disease progression.
- 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 total bilirubin = 1,5 times institutional upper limit of normal (ULN) (Patients with benign hyper bilirubinemia e.g., Gilbert’s syndrome, are eligible )
- eGFR = 40 mL / minute; MDRD formula should be used to calculate the creatinine clearance: http://mdrd.com/. Renal function must be verified within 7 days from treatment start.
- 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
- 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
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method