CompletedNCT02197221IFM2014-02Updated May 23, 2022

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

A Phase 3 interventional study of Bortezomib-Melphalan and Melphalan in Multiple Myeloma, sponsored by University Hospital, Toulouse. Completed at 46 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-23.

Sponsored by University Hospital, Toulouse · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 300
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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 studied

Multiple Myeloma

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In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's enrollment of 300 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 300 participants (actual)

Study arms

Experimental
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: Bortezomib-Melphalan
Active comparator
Melphalan
Melphalan will be administered on day -2. The PBSC will be injected on day 0.
Drug: Melphalan

Interventions

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

What researchers measure

Primary outcomes

Complete Response rates (according to IMWG 2011 criteria)
Time frame: 60 days post Autologous Stem Cells Transplantation
overall survival
Time frame: 60 months

Secondary outcomes

Response rates (according to IMWG 2011 criteria)
Compare response rate after ASCT and after the completion of consolidation therapy
Time frame: post ASCT and consolidation therapy
Serious adverse event
Time frame: End of study
progression-free survival between the two arms
Time frame: 60 months

Study locations

46 sites

Clinique Universitaire Saint Luc
Bruxelles, Belgium
Grand Hôpital de Charleroi - Site Notre-Dame
Charleroi, Belgium
Chu Liege
Liege, Belgium
CHU Dinant-Godinne UCL Namur
Yvoir, Belgium
CH sud Réunion
Saint Pierre, ILE DE LA Reunion, France
Hôpital Felix Guyon
St-denis, 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
Besancon, 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
Creteil, France
CHRU Dijon - Hôpital des Enfants
Dijon, France
Centre Hospitalier Général
Dunkerque, 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
Orleans, 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
St Cloud, France
Institut de Cancérologie de la Loire Lucien Neuwirth
St-priest-en-jarez, France
CHU de Toulouse
Toulouse, 31000, France
Chu Tours
Tours, France
Centre Hospitalier de Versailles-Hôpital André Mignot
Versailles, France

References and documents

Publications

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. Erratum In: Blood. 2023 Mar 09;141(10):1234. doi: 10.1182/blood.2023019751. PubMed 35511184 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02197221
Lead sponsor: University Hospital, Toulouse
Collaborators: Ministry of Health, France, Janssen, LP
Responsible party: Sponsor
First posted: Jul 22, 2014
Start date: Jan 2015
Primary completion: Dec 31, 2018
Completion: Dec 31, 2018
Last update: May 23, 2022

Study contacts

Michel ATTAL, MD, PhD

principal investigator · CHU Toulouse

Murielle ROUSSEL, MD

principal investigator · CHU Toulouse

ROYER, MD

principal investigator · CHU AMIENS

DIB, MD

principal investigator · University Hospital, Angers

CHAOUI, MD

principal investigator · CH ARGENTEUIL

ARAUJO, MD

principal investigator · CH BAYONNE

FONTAN, MD

principal investigator · CH BESANCON

BRECHIGNAC, MD

principal investigator · HOPITAL AVICENNE BOBIGNY

MARIT, Pr

principal investigator · CHU Bordeaux

EVEILLARD, MD

principal investigator · CHU BREST

MACRO, MD

principal investigator · CHU CAEN

MALFUSON, MD

principal investigator · CLAMART PERCY-Hôpital Instruction des Armées

CHALETEIX, MD

principal investigator · University Hospital, Clermont-Ferrand

HUMBRECHT-KRAUT, MD

principal investigator · Hopitaux Civils de Colmar

BELHADJ, MD

principal investigator · CHU Henri Mondor de Creteil

CAILLOT, MD

principal investigator · CHU DIJON

WETTERWALD, MD

principal investigator · CH DUNKERQUE

PEGOURIE, MD

principal investigator · University Hospital, Grenoble

AGAPE, MD

principal investigator · CH LA REUNION-ST DENIS

ZUNIC, MD

principal investigator · CH LA REUNION SAINT PIERRE

LELEU, MD

principal investigator · CHU LILLE

JACCARD, MD

principal investigator · CHU LIMOGES

KARLIN, MD

principal investigator · Hospices Civils de Lyon

NICOLAS, MD

principal investigator · Centre Léon Bérard de LYON

STOPPA, MD

principal investigator · Institut Paoli Calmettes Marseille

DORVAUX, MD

principal investigator · CH METZ

EISENMANN, MD

principal investigator · CH Mulhouse

HULIN, MD

principal investigator · CHU NANCY

MOREAU, Pr

principal investigator · Nantes University Hospital

LEGROS, MD

principal investigator · CHU NICE

BENBRAHIM, MD

principal investigator · CH ORLEANS

BOUSCARY, MD

principal investigator · Hôpital Cochin Paris

KUHNOWSKI, MD

principal investigator · Institut Curie Paris

MOREL, MD

principal investigator · Hôpital la Pitié Salpêtrière Paris

GARDERET, MD

principal investigator · Hôpital Saint Antoine Paris

ARNULF, MD

principal investigator · Hôpital Saint Louis Paris

LACOTTE, MD

principal investigator · CHU Poitiers

DELMER, Pr

principal investigator · CHU REIMS

ESCOFFRE, MD

principal investigator · CHU Rennes

LENAIN, MD

principal investigator · Centre Henri Becquerel de Rouen

GLAISNER, MD

principal investigator · Hôpital René Huguenin - St Cloud

AUGEL MEUNIER, MD

principal investigator · CHU ST PRIEST EN JAREZ

BENBOUBKER, MD

principal investigator · CHU Tours

RIGAUDEAU, MD

principal investigator · CH Versailles

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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