Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma

Study Overview
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Brief Summary
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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.

Official Title
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IFM 2014-02 Study: A Randomized Phase III Study of Bortezomib-Melphalan 200 Conditioning Regimen Versus Melphalan 200 for Frontline Transplant Eligible Patients With Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Bortezomib-Melphalan
* Drug: Melphalan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have results from their initial diagnosis available at the time of screening to confirm all the following : Diagnosis of multiple myeloma according to the diagnostic 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bortezomib-Melphalan<br>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. | Drug: Bortezomib-Melphalan<br>* 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.<br>|
| Active Comparator: Melphalan<br>Melphalan will be administered on day -2. The PBSC will be injected on day 0. | Drug: Melphalan<br>* Melphalan will be administered on day -2. The PBSC will be injected on day 0.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Response rates (according to IMWG 2011 criteria) |  | 60 days post Autologous Stem Cells Transplantation | 
| overall survival |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rates (according to IMWG 2011 criteria) | Compare response rate after ASCT and after the completion of consolidation therapy | post ASCT and consolidation therapy | 
| Serious adverse event |  | End of study | 
| progression-free survival between the two arms |  | 60 months |