Clinical trial NCT02197221: Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Janssen, LP
First posted: 2014-07-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Complete Response rates (according to IMWG 2011 criteria)
timeFrame: 60 days post Autologous Stem Cells Transplantation
measure: overall survival
timeFrame: 60 months
Secondary outcomes:
measure: Response rates (according to IMWG 2011 criteria)
timeFrame: post ASCT and consolidation therapy
measure: Serious adverse event
timeFrame: End of study
measure: progression-free survival between the two arms
timeFrame: 60 months
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Clinique Universitaire Saint Luc
city: Charleroi
country: Belgium
facility: Grand Hôpital de Charleroi - Site Notre-Dame
city: Liege
country: Belgium
facility: Chu Liege
city: Yvoir
country: Belgium
facility: CHU Dinant-Godinne UCL Namur
city: Saint Pierre
country: France
facility: CH sud Réunion
state: ILE DE LA Reunion
city: St-denis
country: France
facility: Hôpital Felix Guyon
state: ILE DE LA Reunion
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: Chu Angers
city: Argenteuil
country: France
facility: CH Argenteuil Victor Dupouy
city: Bayonne
country: France
facility: CH Bayonne
city: Besancon
country: France
facility: Hôpital Jean Minjoz
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: Hôpital du Haut Lévêque
city: Brest
country: France
facility: CHU DE BREST Hôpital A.Morvan
city: Caen
country: France
facility: CHU CAEN
city: Clamart
country: France
facility: Hôpital d'instruction des armées Percy
city: Clermont-ferrand
country: France
facility: CHU d'Estaing
city: Colmar
country: France
facility: Hôpitaux civils de Colmar
city: Creteil
country: France
facility: CHU Henri Mondor
city: Dijon
country: France
facility: CHRU Dijon - Hôpital des Enfants
city: Dunkerque
country: France
facility: Centre Hospitalier Général
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHRU LILLE- Hôpital Claude Huriez
city: Limoges
country: France
facility: Chu Limoges
city: Lyon
country: France
facility: Centre Hospitalier Lyon sud
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Metz
country: France
facility: Hôpital de Mercy - CHR Metz Thionville
city: Mulhouse
country: France
facility: Centre Hospitalier de Mulhouse
city: Nancy
country: France
facility: Chu Nancy
city: Nantes
country: France
facility: Hôtel Dieu
city: Nice
country: France
facility: Hôpital Archet
city: Orleans
country: France
facility: CH d'Orléans
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital de la Pitié Salpêtrière
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital St-Antoine
city: Poitiers
country: France
facility: CHU - Hôpital Jean Bernard
city: Reims
country: France
facility: CHU de Reims- Hôpital R.Debré
city: Rennes
country: France
facility: Hôpital de Pontchaillou
city: Rouen
country: France
facility: Centre Henri Becquerel
city: St Cloud
country: France
facility: Hôpital René Huguenin
city: St-priest-en-jarez
country: France
facility: Institut de Cancérologie de la Loire Lucien Neuwirth
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: Chu Tours
city: Versailles
country: France
facility: Centre Hospitalier de Versailles-Hôpital André Mignot
Study officials:
affiliation: CHU Toulouse
name: Michel ATTAL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Toulouse
name: Murielle ROUSSEL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU AMIENS
name: ROYER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: DIB, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH ARGENTEUIL
name: CHAOUI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH BAYONNE
name: ARAUJO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH BESANCON
name: FONTAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOPITAL AVICENNE BOBIGNY
name: BRECHIGNAC, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: MARIT, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU BREST
name: EVEILLARD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU CAEN
name: MACRO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CLAMART PERCY-Hôpital Instruction des Armées
name: MALFUSON, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Clermont-Ferrand
name: CHALETEIX, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopitaux Civils de Colmar
name: HUMBRECHT-KRAUT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Henri Mondor de Creteil
name: BELHADJ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU DIJON
name: CAILLOT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH DUNKERQUE
name: WETTERWALD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Grenoble
name: PEGOURIE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH LA REUNION-ST DENIS
name: AGAPE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH LA REUNION SAINT PIERRE
name: ZUNIC, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU LILLE
name: LELEU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU LIMOGES
name: JACCARD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospices Civils de Lyon
name: KARLIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Léon Bérard de LYON
name: NICOLAS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Paoli Calmettes Marseille
name: STOPPA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH METZ
name: DORVAUX, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Mulhouse
name: EISENMANN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU NANCY
name: HULIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: MOREAU, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU NICE
name: LEGROS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH ORLEANS
name: BENBRAHIM, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Cochin Paris
name: BOUSCARY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Curie Paris
name: KUHNOWSKI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital la Pitié Salpêtrière Paris
name: MOREL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Saint Antoine Paris
name: GARDERET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Saint Louis Paris
name: ARNULF, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Poitiers
name: LACOTTE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU REIMS
name: DELMER, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: ESCOFFRE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Henri Becquerel de Rouen
name: LENAIN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital René Huguenin - St Cloud
name: GLAISNER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU ST PRIEST EN JAREZ
name: AUGEL MEUNIER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Tours
name: BENBOUBKER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Versailles
name: RIGAUDEAU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roussel M, Lauwers-Cances V, Macro M, Leleu X, Royer B, Hulin C, Karlin L, Perrot A, Touzeau C, Chretien ML, Rigaudeau S, Dib M, Nicolas-Virelizier E, Escoffre-Barbe M, Belhadj K, Mariette C, Stoppa AM, Araujo C, Doyen C, Fontan J, Kolb B, Garderet L, Brechignac S, Malfuson JV, Jaccard A, Lenain P, Borel C, Hebraud B, Benbrahim O, Dorvaux V, Manier S, Augeul-Meunier K, Vekemans MC, Randriamalala E, Chaoui D, Caers J, Chaleteix C, Benboubker L, Vincent L, Glaisner S, Zunic P, Slama B, Eveillard JR, Humbrecht-Kraut C, Morel V, Mineur P, Eisenmann JC, Demarquette H, Richez V, Vignon M, Caillot D, Facon T, Moreau P, Colin AL, Olivier P, Wuilleme S, Avet-Loiseau H, Corre J, Attal M. Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study. Blood. 2022 May 5;139(18):2747-2757. doi: 10.1182/blood.2021014635.