A Phase III Study of Bortezomib-Melphalan 200 Conditioning Regimen Versus Melphalan 200 for Frontline Transplant Eligible Patients With Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bortezomib-Melphalan Type: Drug
Name: Melphalan Type: Drug
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age > or = 18 years and < or = 65 years

- 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
Location
CHU de Toulouse
Toulouse, France
Status: Not yet recruiting
Contact: Amandine HUGUET, Pharm D - 5 61 77 84 90 - huguet.a@chu-toulouse.fr
Start Date
September 2014
Completion Date
September 2020
Sponsors
University Hospital, Toulouse
Source
University Hospital, Toulouse
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page