Status:
COMPLETED
Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Ministry of Health, France
Janssen, LP
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02197221
Start Date
January 1 2015
End Date
December 31 2018
Last Update
May 23 2022
Active Locations (46)
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1
Clinique Universitaire Saint Luc
Brussels, Belgium
2
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Belgium
3
Chu Liege
Liège, Belgium
4
CHU Dinant-Godinne UCL Namur
Yvoir, Belgium