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

May 17, 2022 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Clinique Universitaire Saint LUC
      • Charleroi, Belgium
        • Grand Hôpital de Charleroi - Site Notre-Dame
      • Liege, Belgium
        • CHU Liège
      • Yvoir, Belgium
        • CHU Dinant-Godinne UCL Namur
  • France
      • Amiens, France
        • CHU Amiens
      • Angers, France
        • CHU Angers
      • Argenteuil, France
        • CH Argenteuil Victor Dupouy
      • Bayonne, France
        • CH Bayonne
      • Besancon, France
        • Hôpital Jean Minjoz
      • Bobigny, France
        • Hopital Avicenne
      • Bordeaux, France
        • Hôpital du Haut Lévêque
      • Brest, France
        • CHU DE BREST Hôpital A.Morvan
      • Caen, France
        • CHU Caen
      • Clamart, France
        • Hôpital d'instruction des armées Percy
      • Clermont-ferrand, France
        • CHU d'Estaing
      • Colmar, France
        • Hôpitaux civils de Colmar
      • Creteil, France
        • CHU Henri Mondor
      • Dijon, France
        • CHRU Dijon - Hôpital des Enfants
      • Dunkerque, France
        • Centre Hospitalier Général
      • Grenoble, France
        • Chu Grenoble
      • Lille, France
        • CHRU Lille- Hopital Claude Huriez
      • Limoges, France
        • CHU Limoges
      • Lyon, France
        • Centre Léon Bérard
      • Lyon, France
        • Centre Hospitalier LYON SUD
      • Marseille, France
        • Institut Paoli Calmettes
      • Metz, France
        • Hôpital de Mercy - CHR Metz Thionville
      • Mulhouse, France
        • Centre Hospitalier de Mulhouse
      • Nancy, France
        • CHU Nancy
      • Nantes, France
        • Hôtel Dieu
      • Nice, France
        • Hôpital Archet
      • Orleans, France
        • CH d'Orleans
      • Paris, France
        • Hôpital de la Pitié Salpêtrière
      • Paris, France
        • Hôpital Saint-Louis
      • Paris, France
        • Hôpital Cochin
      • Paris, France
        • Hôpital St-Antoine
      • Poitiers, France
        • CHU - Hôpital Jean Bernard
      • Reims, France
        • CHU de Reims- Hôpital R.Debré
      • Rennes, France
        • Hôpital de Pontchaillou
      • Rouen, France
        • Centre Henri Becquerel
      • St Cloud, France
        • Hopital René Huguenin
      • St-priest-en-jarez, France
        • Institut de Cancérologie de la Loire Lucien Neuwirth
      • Toulouse, France, 31000
        • CHU de Toulouse
      • Tours, France
        • CHU Tours
      • Versailles, France
        • Centre Hospitalier de Versailles-Hôpital André Mignot
    • ILE DE LA Reunion
      • Saint Pierre, ILE DE LA Reunion, France
        • CH Sud Réunion
      • St-denis, ILE DE LA Reunion, France
        • Hôpital Félix Guyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Active Comparator: Melphalan
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
overall survival
Time Frame: 60 months
60 months
Complete Response rates (according to IMWG 2011 criteria)
Time Frame: 60 days post Autologous Stem Cells Transplantation
60 days post Autologous Stem Cells Transplantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
post ASCT and consolidation therapy
Serious adverse event
Time Frame: End of study
End of study
progression-free survival between the two arms
Time Frame: 60 months
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Toulouse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France
Janssen, LP

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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, Hôpital 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, Hôpitaux 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 BERARD 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, CHU Nantes
  • Principal Investigator: LEGROS, MD, CHU NICE
  • Principal Investigator: BENBRAHIM, MD, CH Orléans
  • Principal Investigator: BOUSCARY, MD, Hôpital Cochin Paris
  • Principal Investigator: KUHNOWSKI, MD, Institut Curie Paris
  • Principal Investigator: MOREL, MD, Hôpital La Pitié Salpétrière 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13 7045 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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