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

Multiple Myeloma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197221
• Other study ID #: 13 7045 01
• Status: Completed
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Belgium	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
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	CH sud Réunion	Saint Pierre	ILE DE LA Reunion
France	Hôpital René Huguenin	St Cloud
France	Hôpital Felix Guyon	St-denis	ILE DE LA Reunion
France	Institut de Cancérologie de la Loire Lucien Neuwirth	St-priest-en-jarez
France	CHU de Toulouse	Toulouse
France	Chu Tours	Tours
France	Centre Hospitalier de Versailles-Hôpital André Mignot	Versailles

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Janssen, LP, Ministry of Health, France

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (1)

Roussel M, Lauwers-Cances V, Macro M, Leleu X, Royer B, Hulin C, Karlin L, Perrot A, Touzeau C, Chrétien 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, Bre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response rates (according to IMWG 2011 criteria)		60 days post Autologous Stem Cells Transplantation
Primary	overall survival		60 months
Secondary	Response rates (according to IMWG 2011 criteria)	Compare response rate after ASCT and after the completion of consolidation therapy	post ASCT and consolidation therapy
Secondary	Serious adverse event		End of study
Secondary	progression-free survival between the two arms		60 months