Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
614 participants
INTERVENTIONAL
2006-06-30
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo group
Administration of oral placebo
placebo
oral placebo
lenalidomide group
Administration of lenalidomide
lenalidomide
oral drug
Interventions
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lenalidomide
oral drug
placebo
oral placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Intergroupe Francophone du Myelome
NETWORK
Celgene
INDUSTRY
University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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ATTAL Michel, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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ZNA Middelheim
Antwerp, , Belgium
Algemeen Centrumziekenhuis Antwerpen
Antwerp, , Belgium
UZA Antwerpen
Antwerp, , Belgium
Hôpital Saint Joseph
Arlon, , Belgium
Institut Jules Bordet
Brussels, , Belgium
UCL St Luc
Brussels, , Belgium
Hôpital Saint Joseph
Gilly, , Belgium
Hôpital Jolimont
Haine-Saint-Paul, , Belgium
Heilig Hart Ziekenhuis
Roeselare, , Belgium
UCL Mont-Godinne
Yvoir, , Belgium
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
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
CHRU Hôpital haut Lévêque
Bordeaux, , France
Hôpial Morvan
Brest, , France
Polyclinique du Parc
Caen, , France
Centre Baclesse
Caen, , France
CH
Chartres, , France
CH William Morey
Châlon-sur-Saône, , 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
Dunkirk, , 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
Institut Paoli Calmette
Marseille, , France
Hôpital Nord
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
Hôtel Dieu
Paris, , France
Hôpital Cochin
Paris, , France
CHU Hôpital St Antoine
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 Yves Le Foll
Saint-Brieuc, , France
Centre hospitalier de la Réunion
Saint-Denis, , France
Institut de Cancérologie de la Loire
Saint-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, , France
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
Sankt Gallen, , Switzerland
Spital Thun-Simmental Onkologiezentrum
Thun, , Switzerland
Institute of Oncology and Hematology Stadtspital Triemli
Zurich, , Switzerland
Countries
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References
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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. doi: 10.1200/JCO.1998.16.12.3832.
Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. doi: 10.1056/NEJMoa1114138.
Other Identifiers
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French PHRC
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0400401
Identifier Type: -
Identifier Source: org_study_id
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