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

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.

Conditions

• Multiple Myeloma

Interventions

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.

Sponsors & Collaborators

• Ministry of Health, France

  collaborator OTHER_GOV

• Janssen, LP

  collaborator INDUSTRY

• University Hospital, Toulouse

  lead OTHER

Principal Investigators

• Michel ATTAL, MD, PhD · University Hospital, Toulouse

• Murielle ROUSSEL, MD · University Hospital, Toulouse

• ROYER, MD · CHU AMIENS

• DIB, MD · University Hospital, Angers

• CHAOUI, MD · CH ARGENTEUIL

• ARAUJO, MD · CH BAYONNE

• FONTAN, MD · CH BESANCON

• BRECHIGNAC, MD · HOPITAL AVICENNE BOBIGNY

• MARIT, Pr · University Hospital, Bordeaux

• EVEILLARD, MD · CHU BREST

• MACRO, MD · CHU CAEN

• MALFUSON, MD · CLAMART PERCY-Hôpital Instruction des Armées

• CHALETEIX, MD · University Hospital, Clermont-Ferrand

• HUMBRECHT-KRAUT, MD · Hopitaux Civils de Colmar

• BELHADJ, MD · CHU Henri Mondor de Creteil

• CAILLOT, MD · CHU DIJON

• WETTERWALD, MD · CH DUNKERQUE

• PEGOURIE, MD · University Hospital, Grenoble

• AGAPE, MD · CH LA REUNION-ST DENIS

• ZUNIC, MD · CH LA REUNION SAINT PIERRE

• LELEU, MD · CHU LILLE

• JACCARD, MD · CHU LIMOGES

• KARLIN, MD · Hospices Civils de Lyon

• NICOLAS, MD · Centre Léon Bérard de LYON

• STOPPA, MD · Institut Paoli Calmettes, Marseille

• DORVAUX, MD · CH METZ

• EISENMANN, MD · CH Mulhouse

• HULIN, MD · CHU NANCY

• MOREAU, Pr · Nantes University Hospital

• LEGROS, MD · CHU NICE

• BENBRAHIM, MD · CH ORLEANS

• BOUSCARY, MD · Hôpital Cochin Paris

• KUHNOWSKI, MD · Institut Curie Paris

• MOREL, MD · Hôpital la Pitié Salpêtrière Paris

• GARDERET, MD · Hôpital Saint Antoine Paris

• ARNULF, MD · Hôpital Saint Louis Paris

• LACOTTE, MD · CHU Poitiers

• DELMER, Pr · CHU REIMS

• ESCOFFRE, MD · CHU Rennes

• LENAIN, MD · Centre Henri Becquerel de Rouen

• GLAISNER, MD · Hôpital René Huguenin - St Cloud

• AUGEL MEUNIER, MD · CHU ST PRIEST EN JAREZ

• BENBOUBKER, MD · CHU Tours

• RIGAUDEAU, MD · CH Versailles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• Belgium
• France

Study Locations