Myeloma Clinical Trial
— IFM2005-02Official title:
Relevance of Maintenance Therapy Using Lenalidomide (Revimid®) After Autologous Stem Cell Transplantation Patients Under the Age Of 65. (Open, Randomised, Multi-centric Trial Versus Placebo).
| Verified date | April 2019 |
| Source | University Hospital, Toulouse |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Maintenance treatment of myeloma.
| Status | Completed |
| Enrollment | 614 |
| Est. completion date | September 2018 |
| Est. primary completion date | September 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - No signs of progression after transplant - Effective contraception if necessary (oral contraception for females and barrier methods of contraception for sexually active males) - No active severe infection - Satisfactory restoration of the haematological parameters defined by: PN >1,000/mm3 and Platelets > 75,000/mm3 - Bilirubin < 35 umol/l and GOT/GPT/PAL<3N - Creatinine < 160 umol/l. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Algemeen Centrumziekenhuis Antwerpen | Antwerpen | |
| Belgium | UZA Antwerpen | Antwerpen | |
| Belgium | ZNA Middelheim | Antwerpen | |
| Belgium | Hôpital Saint Joseph | Arlon | |
| Belgium | Institut Jules Bordet | Bruxelles | |
| Belgium | UCL St Luc | Bruxelles | |
| Belgium | Hôpital Saint Joseph | Gilly | |
| Belgium | Hôpital Jolimont | Haine Saint Paul | |
| Belgium | Heilig Hart Ziekenhuis | Roeselare | |
| Belgium | UCL Mont-Godinne | Yvoir | |
| France | CH | Aix-en-Provence | |
| France | CHRU | Amiens | |
| France | CHRU Hôpital du Bocage | Angers | |
| France | Centre hospitalier Argenteuil Victor Dupouy | Argenteuil | |
| France | Centre hospitalier Duffaut | Avignon | |
| France | Centre hospitalier de la côte basque | Bayonne | |
| France | Hôpital Jean Minjoz | Besançon | |
| France | CH | Blois | |
| France | Hôpital Avicenne | Bobigny | |
| France | CHRU Hôpital haut Lévêque | Bordeaux | |
| France | Polyclinique Bordeaux Nord Aquitaine | Bordeaux | |
| France | Hôpial Morvan | Brest | |
| France | Centre Baclesse | Caen | |
| France | Polyclinique du Parc | Caen | |
| France | CH William Morey | Châlon-sur-Saône | |
| France | CH | Chartres | |
| France | Hôpital Antoine Béclère | Clamart | |
| France | Hôpital d'instruction des Armées Percy | Clamart | |
| France | CHRU Hôtel Dieu | Clermont Ferrand | |
| France | CH Louis Pasteur | Colmar | |
| France | CHU Henri Mondor | Créteil | |
| France | CHRU Dijon | Dijon | |
| France | Centre hospitalier général | Dunkerque | |
| France | CHRU Hôpital Michallon | Grenoble | |
| France | Centre hospitalier départemental | La Roche sur Yon | |
| France | CH | Le Mans | |
| France | CHRU Hôpital Claude Huriez | Lille | |
| France | Centre hospitalier Bodelio | Lorient | |
| France | Centre Léon Bérard | Lyon | |
| France | CHU Hôpital Edouard Herriot | Lyon | |
| France | Hôpital Nord | Marseille | |
| France | Institut Paoli Calmette | Marseille | |
| France | Hôpital Notre Dame de Bon Secours | Metz | |
| France | CHRU Hôpitaux de Brabois | Nancy | |
| France | CHRU Hôtel Dieu | Nantes | |
| France | Centre Antoine Lacassagne | Nice | |
| France | Hôpital Archet | Nice | |
| France | Hôpital de l'Archet | Nice | |
| France | CHU Hôpital St Antoine | Paris | |
| France | Hôpital Cochin | Paris | |
| France | Hôtel Dieu | Paris | |
| France | Centre hospitalier Lyon Sud | Pierre Bénite | |
| France | CHRU Hôpital Jean Bernard | Poitiers | |
| France | Centre hospitalier de la région d'Annecy | Pringy | |
| France | Hôpital Debré | Reims | |
| France | CHRU Hôpital de Pontchaillou | Rennes | |
| France | CHRU Hôpital Sud | Rennes | |
| France | Centre hospitalier de Roanne | Roanne | |
| France | Centre Henri Becquerel | Rouen | |
| France | Centre hospitalier de la Réunion | Saint-Denis | |
| France | Centre hospitalier Yves Le Foll | St Brieuc | |
| France | Institut de Cancérologie de la Loire | St-Priest-en-Jarez | |
| France | CHRU Hôpital de Hautepierre | Strasbourg | |
| France | CHU Toulouse Purpan | Toulouse | |
| France | CHU Toulouse Rangueil | Toulouse | |
| France | CHRU Hôpital Bretonneau | Tours | |
| France | Centre hospitalier | Troyes | |
| France | CH Chubert | Vannes | |
| Switzerland | Center of Oncology/Hematology and transfusion Medicine, Kantonsspital | Aarau | |
| Switzerland | Universitäts Spital | Basel | |
| Switzerland | Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli | Bellinzona | |
| Switzerland | Inselspital | Bern | |
| Switzerland | Hôpital cantonal | Genêve | |
| Switzerland | CHUV | Lausanne | |
| Switzerland | Onkologie/Hämatologie Kantonsspital st Gallen | St Gallen | |
| Switzerland | Spital Thun-Simmental Onkologiezentrum | Thun | |
| Switzerland | Institute of Oncology and Hematology Stadtspital Triemli | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Toulouse | Celgene, Intergroupe Francophone du Myelome |
Belgium, France, Switzerland,
Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response. | 2 years | ||
| Secondary | Assess the impact of Revlimid® on the post-transplant complete response rate | 2 years | ||
| Secondary | Compare survival without events and overall survival of patients in the lenalidomide arm with the control | 2 years | ||
| Secondary | Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy. | 3 years |
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