Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma (IFM2014-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02197221

Recruitment Status : Completed

First Posted : July 22, 2014

Last Update Posted : May 23, 2022

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

Ministry of Health, France

Janssen, LP

Information provided by (Responsible Party):

University Hospital, Toulouse

Tracking Information

First Submitted Date ^ICMJE

July 18, 2014

First Posted Date ^ICMJE

July 22, 2014

Last Update Posted Date

May 23, 2022

Study Start Date ^ICMJE

January 2015

Actual Primary Completion Date

December 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

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.

Study Arms ^ICMJE

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.

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

Intervention: Drug: Melphalan

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 9;141(10):1234.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

300

Original Estimated Enrollment ^ICMJE

Same as current

Actual Study Completion Date ^ICMJE

December 31, 2018

Actual Primary Completion Date

December 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 65 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02197221

Other Study ID Numbers ^ICMJE

13 7045 01

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

University Hospital, Toulouse

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

University Hospital, Toulouse

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Ministry of Health, France
Janssen, LP

Investigators ^ICMJE

Principal Investigator:	Michel ATTAL, MD, PhD	CHU Toulouse
Principal Investigator:	Murielle ROUSSEL, MD	CHU 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	CHU 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

PRS Account

University Hospital, Toulouse

Verification Date

May 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top