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AzTrials

Multiple MyelomaPhase 3IFM2014-02NCT02197221

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

A Phase 3 study testing Bortezomib-Melphalan and Melphalan in people with Multiple Myeloma, run by University Hospital, Toulouse at 46 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Bortezomib-Melphalan and Melphalan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
46 sitesin 2 countries
Study dates
Jan 2015to 31 Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

France42 sites

  • CHU Amiens

    Amiens

  • Chu Angers

    Angers

  • CH Argenteuil Victor Dupouy

    Argenteuil

  • CH Bayonne

    Bayonne

  • Hôpital Jean Minjoz

    Besançon

  • Hôpital Avicenne

    Bobigny

  • Hôpital du Haut Lévêque

    Bordeaux

  • CHU DE BREST Hôpital A.Morvan

    Brest

  • CHU CAEN

    Caen

  • Hôpital d'instruction des armées Percy

    Clamart

  • CHU d'Estaing

    Clermont-Ferrand

  • Hôpitaux civils de Colmar

    Colmar

  • CHU Henri Mondor

    Créteil

  • CHRU Dijon - Hôpital des Enfants

    Dijon

  • Centre Hospitalier Général

    Dunkirk

  • CHU Grenoble

    Grenoble

  • CHRU LILLE- Hôpital Claude Huriez

    Lille

  • Chu Limoges

    Limoges

  • Centre Hospitalier Lyon sud

    Lyon

  • Centre Léon Bérard

    Lyon

  • Institut Paoli Calmettes

    Marseille

  • Hôpital de Mercy - CHR Metz Thionville

    Metz

  • Centre Hospitalier de Mulhouse

    Mulhouse

  • Chu Nancy

    Nancy

  • Hôtel Dieu

    Nantes

  • Hôpital Archet

    Nice

  • CH d'Orléans

    Orléans

  • Hôpital Cochin

    Paris

  • Hôpital de la Pitié Salpêtrière

    Paris

  • Hôpital Saint-Louis

    Paris

  • Hôpital St-Antoine

    Paris

  • CHU - Hôpital Jean Bernard

    Poitiers

  • CHU de Reims- Hôpital R.Debré

    Reims

  • Hôpital de Pontchaillou

    Rennes

  • Centre Henri Becquerel

    Rouen

  • Hôpital René Huguenin

    Saint-Cloud

  • Hôpital Felix Guyon

    Saint-Denis, ILE de LA Reunion

  • CH sud Réunion

    Saint-Pierre, ILE de LA Reunion

  • Institut de Cancérologie de la Loire Lucien Neuwirth

    Saint-Priest-en-Jarez

  • CHU de Toulouse

    Toulouse, 31000

  • Chu Tours

    Tours

  • Centre Hospitalier de Versailles-Hôpital André Mignot

    Versailles

Other trials in France

Belgium4 sites

  • Clinique Universitaire Saint Luc

    Brussels

  • Grand Hôpital de Charleroi - Site Notre-Dame

    Charleroi

  • Chu Liege

    Liège

  • CHU Dinant-Godinne UCL Namur

    Yvoir

Other trials in Belgium

About this study

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

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.

Being tested
Bortezomib-Melphalan, Melphalan
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bortezomib-MelphalanDrug

    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.

  • MelphalanDrug

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

Study groups in NCT02197221
Study groupRoleWhat they receive
Bortezomib-MelphalanExperimentalBortezomib will be administered on days: -6, -3 +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.
Receives: Drug: Bortezomib-Melphalan
MelphalanActive comparatorMelphalan will be administered on day -2. The PBSC will be injected on day 0.
Receives: Drug: Melphalan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response rates (according to IMWG 2011 criteria)

    Measured: 60 days post Autologous Stem Cells Transplantation

  2. overall survival

    Measured: 60 months

Secondary outcomes (3)

  1. Response rates (according to IMWG 2011 criteria)

    Compare response rate after ASCT and after the completion of consolidation therapy

    Measured: post ASCT and consolidation therapy

  2. Serious adverse event

    Measured: End of study

  3. progression-free survival between the two arms

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2014 (estimated)
  2. Study startJan 2015
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02197221
Sponsor's protocol ID
13 7045 01
Acronym
IFM2014-02
Status last verified
May 2022
First submitted
18 Jul 2014
Last updated
23 May 2022
Results posted
No
Data monitoring committee
No

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.

    PubMed 35511184

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bortezomib-Melphalan and Melphalan in people with Multiple Myeloma, run by University Hospital, Toulouse at 46 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response rates (according to IMWG 2011 criteria) (time frame: 60 days post Autologous Stem Cells Transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02197221, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.

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