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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Janssen, LP | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib-Melphalan | Experimental | 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 | Active Comparator | Melphalan will be administered on day -2. The PBSC will be injected on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib-Melphalan | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response rates (according to IMWG 2011 criteria) | 60 days post Autologous Stem Cells Transplantation | |
| overall survival | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rates (according to IMWG 2011 criteria) | Compare response rate after ASCT and after the completion of consolidation therapy | post ASCT and consolidation therapy |
| Serious adverse event |
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Inclusion Criteria:
Must have results from their initial diagnosis available at the time of screening to confirm all the following :
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:
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| Name | Affiliation | Role |
|---|---|---|
| Michel ATTAL, MD, PhD | University Hospital, Toulouse | Principal Investigator |
| Murielle ROUSSEL, MD | University Hospital, 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 | University Hospital, Bordeaux | Principal Investigator |
| EVEILLARD, MD | CHU BREST |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Universitaire Saint Luc | Brussels | Belgium | ||||
| Grand Hôpital de Charleroi - Site Notre-Dame |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35511184 | Result | 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. |
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| Melphalan | Drug | Melphalan will be administered on day -2. The PBSC will be injected on day 0. |
|
| End of study |
| progression-free survival between the two arms | 60 months |
| MACRO, MD | University Hospital, 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 | Central Hospital, Nancy, France | Principal Investigator |
| MOREAU, Pr | Nantes University Hospital | Principal Investigator |
| LEGROS, MD | Centre Hospitalier Universitaire de 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 de Reims | Principal Investigator |
| ESCOFFRE, MD | Rennes University Hospital | 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 | Principal Investigator |
| Charleroi |
| Belgium |
| Chu Liege | Liège | Belgium |
| CHU Dinant-Godinne UCL Namur | Yvoir | Belgium |
| Hôpital Felix Guyon | Saint-Denis | ILE de LA Reunion | France |
| CH sud Réunion | Saint-Pierre | ILE de LA Reunion | France |
| CHU Amiens | Amiens | France |
| Chu Angers | Angers | France |
| CH Argenteuil Victor Dupouy | Argenteuil | France |
| CH Bayonne | Bayonne | France |
| Hôpital Jean Minjoz | Besançon | 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 | Créteil | France |
| CHRU Dijon - Hôpital des Enfants | Dijon | France |
| Centre Hospitalier Général | Dunkirk | 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 | Orléans | 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 |
| Hôpital René Huguenin | Saint-Cloud | France |
| Institut de Cancérologie de la Loire Lucien Neuwirth | Saint-Priest-en-Jarez | France |
| CHU de Toulouse | Toulouse | 31000 | France |
| Chu Tours | Tours | France |
| Centre Hospitalier de Versailles-Hôpital André Mignot | Versailles | France |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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