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

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Collaborators: Janssen, LP; Ministry of Health, France
• Treatments: Bortezomib; Melphalan

Criteria

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