Back to resultsBortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma (IFM2014-02)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bortezomib-Melphalan
Melphalan
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
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
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
Sites / Locations
- Clinique Universitaire Saint Luc
- Grand Hôpital de Charleroi - Site Notre-Dame
- Chu Liege
- CHU Dinant-Godinne UCL Namur
- CH sud Réunion
- Hôpital Felix Guyon
- CHU Amiens
- Chu Angers
- CH Argenteuil Victor Dupouy
- CH Bayonne
- Hôpital Jean Minjoz
- Hôpital Avicenne
- Hôpital du Haut Lévêque
- CHU DE BREST Hôpital A.Morvan
- CHU CAEN
- Hôpital d'instruction des armées Percy
- CHU d'Estaing
- Hôpitaux civils de Colmar
- CHU Henri Mondor
- CHRU Dijon - Hôpital des Enfants
- Centre Hospitalier Général
- CHU Grenoble
- CHRU LILLE- Hôpital Claude Huriez
- Chu Limoges
- Centre Hospitalier Lyon sud
- Centre Léon Bérard
- Institut Paoli Calmettes
- Hôpital de Mercy - CHR Metz Thionville
- Centre Hospitalier de Mulhouse
- Chu Nancy
- Hôtel Dieu
- Hôpital Archet
- CH d'Orléans
- Hôpital Cochin
- Hôpital de la Pitié Salpêtrière
- Hôpital Saint-Louis
- Hôpital St-Antoine
- CHU - Hôpital Jean Bernard
- CHU de Reims- Hôpital R.Debré
- Hôpital de Pontchaillou
- Centre Henri Becquerel
- Hôpital René Huguenin
- Institut de Cancérologie de la Loire Lucien Neuwirth
- CHU de Toulouse
- Chu Tours
- Centre Hospitalier de Versailles-Hôpital André Mignot
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bortezomib-Melphalan
Melphalan
Arm Description
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 will be administered on day -2. The PBSC will be injected on day 0.
Outcomes
Primary Outcome Measures
Complete Response rates (according to IMWG 2011 criteria)
overall survival
Secondary Outcome Measures
Response rates (according to IMWG 2011 criteria)
Compare response rate after ASCT and after the completion of consolidation therapy
Serious adverse event
progression-free survival between the two arms
Full Information
NCT ID
NCT02197221
First Posted
July 18, 2014
Last Updated
May 17, 2022
Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France, Janssen, LP
1. Study Identification
Unique Protocol Identification Number
NCT02197221
Brief Title
Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma
Acronym
IFM2014-02
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Ministry of Health, France, Janssen, LP
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bortezomib-Melphalan
Arm Type
Experimental
Arm Description
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.
Arm Title
Melphalan
Arm Type
Active Comparator
Arm Description
Melphalan will be administered on day -2. The PBSC will be injected on day 0.
Intervention Type
Drug
Intervention Name(s)
Bortezomib-Melphalan
Intervention Description
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
Intervention Name(s)
Melphalan
Intervention Description
Melphalan will be administered on day -2. The PBSC will be injected on day 0.
Primary Outcome Measure Information:
Title
Complete Response rates (according to IMWG 2011 criteria)
Time Frame
60 days post Autologous Stem Cells Transplantation
Title
overall survival
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Response rates (according to IMWG 2011 criteria)
Description
Compare response rate after ASCT and after the completion of consolidation therapy
Time Frame
post ASCT and consolidation therapy
Title
Serious adverse event
Time Frame
End of study
Title
progression-free survival between the two arms
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel ATTAL, MD, PhD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Murielle ROUSSEL, MD
Organizational Affiliation
CHU Toulouse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ROYER, MD
Organizational Affiliation
CHU AMIENS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DIB, MD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CHAOUI, MD
Organizational Affiliation
CH ARGENTEUIL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ARAUJO, MD
Organizational Affiliation
CH BAYONNE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
FONTAN, MD
Organizational Affiliation
CH BESANCON
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BRECHIGNAC, MD
Organizational Affiliation
HOPITAL AVICENNE BOBIGNY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MARIT, Pr
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
EVEILLARD, MD
Organizational Affiliation
CHU BREST
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MACRO, MD
Organizational Affiliation
CHU CAEN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MALFUSON, MD
Organizational Affiliation
CLAMART PERCY-Hôpital Instruction des Armées
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CHALETEIX, MD
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HUMBRECHT-KRAUT, MD
Organizational Affiliation
Hopitaux Civils de Colmar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BELHADJ, MD
Organizational Affiliation
CHU Henri Mondor de Creteil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CAILLOT, MD
Organizational Affiliation
CHU DIJON
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
WETTERWALD, MD
Organizational Affiliation
CH DUNKERQUE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PEGOURIE, MD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AGAPE, MD
Organizational Affiliation
CH LA REUNION-ST DENIS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ZUNIC, MD
Organizational Affiliation
CH LA REUNION SAINT PIERRE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LELEU, MD
Organizational Affiliation
CHU LILLE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JACCARD, MD
Organizational Affiliation
CHU LIMOGES
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
KARLIN, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
NICOLAS, MD
Organizational Affiliation
Centre Léon Bérard de LYON
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
STOPPA, MD
Organizational Affiliation
Institut Paoli Calmettes Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DORVAUX, MD
Organizational Affiliation
CH METZ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
EISENMANN, MD
Organizational Affiliation
CH MULHOUSE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
HULIN, MD
Organizational Affiliation
CHU NANCY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MOREAU, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LEGROS, MD
Organizational Affiliation
CHU NICE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BENBRAHIM, MD
Organizational Affiliation
CH ORLEANS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BOUSCARY, MD
Organizational Affiliation
Hôpital Cochin Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
KUHNOWSKI, MD
Organizational Affiliation
Institut Curie Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MOREL, MD
Organizational Affiliation
Hôpital la Pitié Salpêtrière Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
GARDERET, MD
Organizational Affiliation
Hôpital Saint Antoine Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ARNULF, MD
Organizational Affiliation
Hôpital Saint Louis Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LACOTTE, MD
Organizational Affiliation
CHU Poitiers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
DELMER, Pr
Organizational Affiliation
CHU REIMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ESCOFFRE, MD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LENAIN, MD
Organizational Affiliation
Centre Henri Becquerel de Rouen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
GLAISNER, MD
Organizational Affiliation
Hôpital René Huguenin - St Cloud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
AUGEL MEUNIER, MD
Organizational Affiliation
CHU ST PRIEST EN JAREZ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BENBOUBKER, MD
Organizational Affiliation
CHU Tours
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
RIGAUDEAU, MD
Organizational Affiliation
CH Versailles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Universitaire Saint Luc
City
Bruxelles
Country
Belgium
Facility Name
Grand Hôpital de Charleroi - Site Notre-Dame
City
Charleroi
Country
Belgium
Facility Name
Chu Liege
City
Liege
Country
Belgium
Facility Name
CHU Dinant-Godinne UCL Namur
City
Yvoir
Country
Belgium
Facility Name
CH sud Réunion
City
Saint Pierre
State/Province
ILE DE LA Reunion
Country
France
Facility Name
Hôpital Felix Guyon
City
St-denis
State/Province
ILE DE LA Reunion
Country
France
Facility Name
CHU Amiens
City
Amiens
Country
France
Facility Name
Chu Angers
City
Angers
Country
France
Facility Name
CH Argenteuil Victor Dupouy
City
Argenteuil
Country
France
Facility Name
CH Bayonne
City
Bayonne
Country
France
Facility Name
Hôpital Jean Minjoz
City
Besancon
Country
France
Facility Name
Hôpital Avicenne
City
Bobigny
Country
France
Facility Name
Hôpital du Haut Lévêque
City
Bordeaux
Country
France
Facility Name
CHU DE BREST Hôpital A.Morvan
City
Brest
Country
France
Facility Name
CHU CAEN
City
Caen
Country
France
Facility Name
Hôpital d'instruction des armées Percy
City
Clamart
Country
France
Facility Name
CHU d'Estaing
City
Clermont-ferrand
Country
France
Facility Name
Hôpitaux civils de Colmar
City
Colmar
Country
France
Facility Name
CHU Henri Mondor
City
Creteil
Country
France
Facility Name
CHRU Dijon - Hôpital des Enfants
City
Dijon
Country
France
Facility Name
Centre Hospitalier Général
City
Dunkerque
Country
France
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Facility Name
CHRU LILLE- Hôpital Claude Huriez
City
Lille
Country
France
Facility Name
Chu Limoges
City
Limoges
Country
France
Facility Name
Centre Hospitalier Lyon sud
City
Lyon
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
Country
France
Facility Name
Hôpital de Mercy - CHR Metz Thionville
City
Metz
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
Country
France
Facility Name
Chu Nancy
City
Nancy
Country
France
Facility Name
Hôtel Dieu
City
Nantes
Country
France
Facility Name
Hôpital Archet
City
Nice
Country
France
Facility Name
CH d'Orléans
City
Orleans
Country
France
Facility Name
Hôpital Cochin
City
Paris
Country
France
Facility Name
Hôpital de la Pitié Salpêtrière
City
Paris
Country
France
Facility Name
Hôpital Saint-Louis
City
Paris
Country
France
Facility Name
Hôpital St-Antoine
City
Paris
Country
France
Facility Name
CHU - Hôpital Jean Bernard
City
Poitiers
Country
France
Facility Name
CHU de Reims- Hôpital R.Debré
City
Reims
Country
France
Facility Name
Hôpital de Pontchaillou
City
Rennes
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Hôpital René Huguenin
City
St Cloud
Country
France
Facility Name
Institut de Cancérologie de la Loire Lucien Neuwirth
City
St-priest-en-jarez
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Chu Tours
City
Tours
Country
France
Facility Name
Centre Hospitalier de Versailles-Hôpital André Mignot
City
Versailles
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35511184
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. Erratum In: Blood. 2023 Mar 9;141(10):1234.
Results Reference
result
Learn more about this trial
Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma
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