Overview

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