Trial | NCT02197221  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    300
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.
Study Started
Jan 31
2015
Primary Completion
Dec 31
2018
Study Completion
Dec 31
2018
Last Update
May 23
2022

Drug Bortezomib-Melphalan

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 Melphalan

Melphalan will be administered on day -2. The PBSC will be injected on day 0.

Bortezomib-Melphalan Experimental

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.

Melphalan Active Comparator

Melphalan will be administered on day -2. The PBSC will be injected on day 0.

Criteria 

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
No Results Posted