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

NCT ID: NCT02197221

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-12-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bortezomib-Melphalan

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Melphalan

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Melphalan

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Janssen, LP

INDUSTRY

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel ATTAL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Murielle ROUSSEL, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

ROYER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU AMIENS

DIB, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

CHAOUI, MD

Role: PRINCIPAL_INVESTIGATOR

CH ARGENTEUIL

ARAUJO, MD

Role: PRINCIPAL_INVESTIGATOR

CH BAYONNE

FONTAN, MD

Role: PRINCIPAL_INVESTIGATOR

CH BESANCON

BRECHIGNAC, MD

Role: PRINCIPAL_INVESTIGATOR

HOPITAL AVICENNE BOBIGNY

MARIT, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

EVEILLARD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU BREST

MACRO, MD

Role: PRINCIPAL_INVESTIGATOR

CHU CAEN

MALFUSON, MD

Role: PRINCIPAL_INVESTIGATOR

CLAMART PERCY-Hôpital Instruction des Armées

CHALETEIX, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

HUMBRECHT-KRAUT, MD

Role: PRINCIPAL_INVESTIGATOR

Hopitaux Civils de Colmar

BELHADJ, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Henri Mondor de Creteil

CAILLOT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU DIJON

WETTERWALD, MD

Role: PRINCIPAL_INVESTIGATOR

CH DUNKERQUE

PEGOURIE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

AGAPE, MD

Role: PRINCIPAL_INVESTIGATOR

CH LA REUNION-ST DENIS

ZUNIC, MD

Role: PRINCIPAL_INVESTIGATOR

CH LA REUNION SAINT PIERRE

LELEU, MD

Role: PRINCIPAL_INVESTIGATOR

CHU LILLE

JACCARD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU LIMOGES

KARLIN, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

NICOLAS, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard de LYON

STOPPA, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli Calmettes, Marseille

DORVAUX, MD

Role: PRINCIPAL_INVESTIGATOR

CH METZ

EISENMANN, MD

Role: PRINCIPAL_INVESTIGATOR

CH Mulhouse

HULIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NANCY

MOREAU, Pr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

LEGROS, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

BENBRAHIM, MD

Role: PRINCIPAL_INVESTIGATOR

CH ORLEANS

BOUSCARY, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Cochin Paris

KUHNOWSKI, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie Paris

MOREL, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital la Pitié Salpêtrière Paris

GARDERET, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Antoine Paris

ARNULF, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Louis Paris

LACOTTE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Poitiers

DELMER, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU REIMS

ESCOFFRE, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

LENAIN, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel de Rouen

GLAISNER, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital René Huguenin - St Cloud

AUGEL MEUNIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU ST PRIEST EN JAREZ

BENBOUBKER, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Tours

RIGAUDEAU, MD

Role: PRINCIPAL_INVESTIGATOR

CH Versailles

Locations

Clinique Universitaire Saint Luc

Brussels, , Belgium

Grand Hôpital de Charleroi - Site Notre-Dame

Charleroi, , Belgium

Chu Liege

Liège, , Belgium

CHU Dinant-Godinne UCL Namur

Yvoir, , Belgium

Hôpital Felix Guyon

Saint-Denis, ILE de LA Reunion, France

CH sud Réunion

Saint-Pierre, ILE de LA Reunion, France

CHU Amiens

Amiens, , France

Chu Angers

Angers, , France

CH Argenteuil Victor Dupouy

Argenteuil, , France

CH Bayonne

Bayonne, , France

Hôpital Jean Minjoz

Besançon, , France

Hôpital Avicenne

Bobigny, , France

Hôpital du Haut Lévêque

Bordeaux, , France

CHU DE BREST Hôpital A.Morvan

Brest, , France

CHU CAEN

Caen, , France

Hôpital d'instruction des armées Percy

Clamart, , France

CHU d'Estaing

Clermont-Ferrand, , France

Hôpitaux civils de Colmar

Colmar, , France

CHU Henri Mondor

Créteil, , France

CHRU Dijon - Hôpital des Enfants

Dijon, , France

Centre Hospitalier Général

Dunkirk, , France

CHU Grenoble

Grenoble, , France

CHRU LILLE- Hôpital Claude Huriez

Lille, , France

Chu Limoges

Limoges, , France

Centre Hospitalier Lyon sud

Lyon, , France

Centre Léon Bérard

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

Hôpital de Mercy - CHR Metz Thionville

Metz, , France

Centre Hospitalier de Mulhouse

Mulhouse, , France

Chu Nancy

Nancy, , France

Hôtel Dieu

Nantes, , France

Hôpital Archet

Nice, , France

CH d'Orléans

Orléans, , France

Hôpital Cochin

Paris, , France

Hôpital de la Pitié Salpêtrière

Paris, , France

Hôpital Saint-Louis

Paris, , France

Hôpital St-Antoine

Paris, , France

CHU - Hôpital Jean Bernard

Poitiers, , France

CHU de Reims- Hôpital R.Debré

Reims, , France

Hôpital de Pontchaillou

Rennes, , France

Centre Henri Becquerel

Rouen, , France

Hôpital René Huguenin

Saint-Cloud, , France

Institut de Cancérologie de la Loire Lucien Neuwirth

Saint-Priest-en-Jarez, , France

CHU de Toulouse

Toulouse, , France

Chu Tours

Tours, , France

Centre Hospitalier de Versailles-Hôpital André Mignot

Versailles, , France

Countries

Belgium; France

References

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.

Reference Type: RESULT

PMID: 35511184 (View on PubMed)

Other Identifiers

13 7045 01

Identifier Type: -

Identifier Source: org_study_id