Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma (IFM2014-02)
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| ClinicalTrials.gov Identifier: NCT02197221 |
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Recruitment Status :
Completed
First Posted : July 22, 2014
Last Update Posted : May 23, 2022
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Sponsor:
University Hospital, Toulouse
Collaborators:
Ministry of Health, France
Janssen, LP
Information provided by (Responsible Party):
University Hospital, Toulouse
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: Bortezomib-Melphalan Drug: Melphalan | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | January 2015 |
| Actual Primary Completion Date : | December 31, 2018 |
| Actual Study Completion Date : | December 31, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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Active Comparator: Melphalan
Melphalan will be administered on day -2. The PBSC will be injected on day 0.
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Drug: Melphalan
Melphalan will be administered on day -2. The PBSC will be injected on day 0. |
Primary Outcome Measures :
- Complete Response rates (according to IMWG 2011 criteria) [ Time Frame: 60 days post Autologous Stem Cells Transplantation ]
- overall survival [ Time Frame: 60 months ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197221
Locations
Show 46 study locations
Sponsors and Collaborators
University Hospital, Toulouse
Ministry of Health, France
Janssen, LP
Investigators
| 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 |
Publications of Results:
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT02197221 |
| Other Study ID Numbers: |
13 7045 01 |
| First Posted: | July 22, 2014 Key Record Dates |
| Last Update Posted: | May 23, 2022 |
| Last Verified: | May 2022 |
Additional relevant MeSH terms:
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Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders |
Immunoproliferative Disorders Immune System Diseases Bortezomib Melphalan Antineoplastic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |