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

NCT02197221 | Completed Phase 3

• 1 other identifier: 13 7045 01
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 46

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

Outcome Measures

Primary Outcomes (2)

• Complete Response rates (according to IMWG 2011 criteria)

  60 days post Autologous Stem Cells Transplantation

• overall survival

  60 months

Secondary Outcomes (3)

• Response rates (according to IMWG 2011 criteria)

  post ASCT and consolidation therapy

• Serious adverse event

  End of study

• progression-free survival between the two arms

  60 months

Study Arms (2)

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.

Drug: Bortezomib-Melphalan

Melphalan

ACTIVE COMPARATOR

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

Drug: Melphalan

Interventions

Bortezomib-Melphalan 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.

Bortezomib-Melphalan

Melphalan DRUG

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

Melphalan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Progressive disease
• Females participants pregnant or breast-feeding
• A known infection by the human immunodeficiency virus
• An active viral hepatitis B or C
• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Ministry of Health, France: collaborator
• Janssen, LP: collaborator

Study Sites (46)

Clinique Universitaire Saint Luc

Brussels, Belgium

Location

Grand Hôpital de Charleroi - Site Notre-Dame

Charleroi, Belgium

Location

Chu Liege

Liège, Belgium

Location

CHU Dinant-Godinne UCL Namur

Yvoir, Belgium

Location

Hôpital Felix Guyon

Saint-Denis, ILE de LA Reunion, France

Location

CH sud Réunion

Saint-Pierre, ILE de LA Reunion, France

Location

CHU Amiens

Amiens, France

Location

Chu Angers

Angers, France

Location

CH Argenteuil Victor Dupouy

Argenteuil, France

Location

CH Bayonne

Bayonne, France

Location

Hôpital Jean Minjoz

Besançon, France

Location

Hôpital Avicenne

Bobigny, France

Location

Hôpital du Haut Lévêque

Bordeaux, France

Location

CHU DE BREST Hôpital A.Morvan

Brest, France

Location

CHU CAEN

Caen, France

Location

Hôpital d'instruction des armées Percy

Clamart, France

Location

CHU d'Estaing

Clermont-Ferrand, France

Location

Hôpitaux civils de Colmar

Colmar, France

Location

CHU Henri Mondor

Créteil, France

Location

CHRU Dijon - Hôpital des Enfants

Dijon, France

Location

Centre Hospitalier Général

Dunkirk, France

Location

CHU Grenoble

Grenoble, France

Location

CHRU LILLE- Hôpital Claude Huriez

Lille, France

Location

Chu Limoges

Limoges, France

Location

Centre Hospitalier Lyon sud

Lyon, France

Location

Centre Léon Bérard

Lyon, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Hôpital de Mercy - CHR Metz Thionville

Metz, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, France

Location

Chu Nancy

Nancy, France

Location

Hôtel Dieu

Nantes, France

Location

Hôpital Archet

Nice, France

Location

CH d'Orléans

Orléans, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital de la Pitié Salpêtrière

Paris, France

Location

Hôpital Saint-Louis

Paris, France

Location

Hôpital St-Antoine

Paris, France

Location

CHU - Hôpital Jean Bernard

Poitiers, France

Location

CHU de Reims- Hôpital R.Debré

Reims, France

Location

Hôpital de Pontchaillou

Rennes, France

Location

Centre Henri Becquerel

Rouen, France

Location

Hôpital René Huguenin

Saint-Cloud, France

Location

Institut de Cancérologie de la Loire Lucien Neuwirth

Saint-Priest-en-Jarez, France

Location

CHU de Toulouse

Toulouse, 31000, France

Location

Chu Tours

Tours, France

Location

Centre Hospitalier de Versailles-Hôpital André Mignot

Versailles, France

Location

Related Publications (1)

• 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.

  PMID: 35511184 RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Michel ATTAL, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

• Murielle ROUSSEL, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

• ROYER, MD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

• DIB, MD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

• CHAOUI, MD

  CH ARGENTEUIL

  PRINCIPAL INVESTIGATOR

• ARAUJO, MD

  CH BAYONNE

  PRINCIPAL INVESTIGATOR

• FONTAN, MD

  CH BESANCON

  PRINCIPAL INVESTIGATOR

• BRECHIGNAC, MD

  HOPITAL AVICENNE BOBIGNY

  PRINCIPAL INVESTIGATOR

• MARIT, Pr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• EVEILLARD, MD

  CHU BREST

  PRINCIPAL INVESTIGATOR

• MACRO, MD

  CHU CAEN

  PRINCIPAL INVESTIGATOR

• MALFUSON, MD

  CLAMART PERCY-Hôpital Instruction des Armées

  PRINCIPAL INVESTIGATOR

• CHALETEIX, MD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

• HUMBRECHT-KRAUT, MD

  Hopitaux Civils de Colmar

  PRINCIPAL INVESTIGATOR

• BELHADJ, MD

  CHU Henri Mondor de Creteil

  PRINCIPAL INVESTIGATOR

• CAILLOT, MD

  CHU DIJON

  PRINCIPAL INVESTIGATOR

• WETTERWALD, MD

  CH DUNKERQUE

  PRINCIPAL INVESTIGATOR

• PEGOURIE, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• AGAPE, MD

  CH LA REUNION-ST DENIS

  PRINCIPAL INVESTIGATOR

• ZUNIC, MD

  CH LA REUNION SAINT PIERRE

  PRINCIPAL INVESTIGATOR

• LELEU, MD

  CHU LILLE

  PRINCIPAL INVESTIGATOR

• JACCARD, MD

  CHU LIMOGES

  PRINCIPAL INVESTIGATOR

• KARLIN, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

• NICOLAS, MD

  Centre Léon Bérard de LYON

  PRINCIPAL INVESTIGATOR

• STOPPA, MD

  Institut Paoli Calmettes, Marseille

  PRINCIPAL INVESTIGATOR

• DORVAUX, MD

  CH METZ

  PRINCIPAL INVESTIGATOR

• EISENMANN, MD

  CH Mulhouse

  PRINCIPAL INVESTIGATOR

• HULIN, MD

  CHU NANCY

  PRINCIPAL INVESTIGATOR

• MOREAU, Pr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• LEGROS, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

• BENBRAHIM, MD

  CH ORLEANS

  PRINCIPAL INVESTIGATOR

• BOUSCARY, MD

  Hôpital Cochin Paris

  PRINCIPAL INVESTIGATOR

• KUHNOWSKI, MD

  Institut Curie Paris

  PRINCIPAL INVESTIGATOR

• MOREL, MD

  Hôpital la Pitié Salpêtrière Paris

  PRINCIPAL INVESTIGATOR

• GARDERET, MD

  Hôpital Saint Antoine Paris

  PRINCIPAL INVESTIGATOR

• ARNULF, MD

  Hôpital Saint Louis Paris

  PRINCIPAL INVESTIGATOR

• LACOTTE, MD

  CHU Poitiers

  PRINCIPAL INVESTIGATOR

• DELMER, Pr

  CHU REIMS

  PRINCIPAL INVESTIGATOR

• ESCOFFRE, MD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• LENAIN, MD

  Centre Henri Becquerel de Rouen

  PRINCIPAL INVESTIGATOR

• GLAISNER, MD

  Hôpital René Huguenin - St Cloud

  PRINCIPAL INVESTIGATOR

• AUGEL MEUNIER, MD

  CHU ST PRIEST EN JAREZ

  PRINCIPAL INVESTIGATOR

• BENBOUBKER, MD

  CHU Tours

  PRINCIPAL INVESTIGATOR

• RIGAUDEAU, MD

  CH Versailles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: January 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

FR (42); BE (4)