Clinical trial NCT00430365: Maintenance Therapy Using Lenalidomide in Myeloma
Official 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myeloma
Keywords: Myeloma
Revlimid
Maintenance therapy
Autologous Stem Cell Transplantation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Intergroupe Francophone du Myelome
name: Celgene
First posted: 2007-02-01
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Maintenance treatment of myeloma.


Eligibility criteria: 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.

Primary outcomes:
measure: Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
timeFrame: 2 years
Secondary outcomes:
measure: Assess the impact of Revlimid® on the post-transplant complete response rate
timeFrame: 2 years
measure: Compare survival without events and overall survival of patients in the lenalidomide arm with the control
timeFrame: 2 years
measure: Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.
timeFrame: 3 years
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Antwerpen
country: Belgium
facility: Algemeen Centrumziekenhuis Antwerpen
city: Antwerpen
country: Belgium
facility: UZA Antwerpen
city: Arlon
country: Belgium
facility: Hôpital Saint Joseph
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: UCL St Luc
city: Gilly
country: Belgium
facility: Hôpital Saint Joseph
city: Haine Saint Paul
country: Belgium
facility: Hôpital Jolimont
city: Roeselare
country: Belgium
facility: Heilig Hart Ziekenhuis
city: Yvoir
country: Belgium
facility: UCL Mont-Godinne
city: Aix-en-Provence
country: France
facility: CH
city: Amiens
country: France
facility: CHRU
city: Angers
country: France
facility: CHRU Hôpital du Bocage
city: Argenteuil
country: France
facility: Centre hospitalier Argenteuil Victor Dupouy
city: Avignon
country: France
facility: Centre hospitalier Duffaut
city: Bayonne
country: France
facility: Centre hospitalier de la côte basque
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Blois
country: France
facility: CH
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Bordeaux
country: France
facility: CHRU Hôpital haut Lévêque
city: Brest
country: France
facility: Hôpial Morvan
city: Caen
country: France
facility: Polyclinique du Parc
city: Caen
country: France
facility: Centre Baclesse
city: Chartres
country: France
facility: CH
city: Châlon-sur-Saône
country: France
facility: CH William Morey
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Clamart
country: France
facility: Hôpital d'instruction des Armées Percy
city: Clermont Ferrand
country: France
facility: CHRU Hôtel Dieu
city: Colmar
country: France
facility: CH Louis Pasteur
city: Créteil
country: France
facility: CHU Henri Mondor
city: Dijon
country: France
facility: CHRU Dijon
city: Dunkerque
country: France
facility: Centre hospitalier général
city: Grenoble
country: France
facility: CHRU Hôpital Michallon
city: La Roche sur Yon
country: France
facility: Centre hospitalier départemental
city: Le Mans
country: France
facility: CH
city: Lille
country: France
facility: CHRU Hôpital Claude Huriez
city: Lorient
country: France
facility: Centre hospitalier Bodelio
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: CHU Hôpital Edouard Herriot
city: Marseille
country: France
facility: Institut Paoli Calmette
city: Marseille
country: France
facility: Hôpital Nord
city: Metz
country: France
facility: Hôpital Notre Dame de Bon Secours
city: Nancy
country: France
facility: CHRU Hôpitaux de Brabois
city: Nantes
country: France
facility: CHRU Hôtel Dieu
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Hôpital Archet
city: Nice
country: France
facility: Hôpital de l'Archet
city: Paris
country: France
facility: Hôtel Dieu
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: CHU Hôpital St Antoine
city: Pierre Bénite
country: France
facility: Centre hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHRU Hôpital Jean Bernard
city: Pringy
country: France
facility: Centre hospitalier de la région d'Annecy
city: Reims
country: France
facility: Hôpital Debré
city: Rennes
country: France
facility: CHRU Hôpital de Pontchaillou
city: Rennes
country: France
facility: CHRU Hôpital Sud
city: Roanne
country: France
facility: Centre hospitalier de Roanne
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Denis
country: France
facility: Centre hospitalier de la Réunion
city: St Brieuc
country: France
facility: Centre hospitalier Yves Le Foll
city: St-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de la Loire
city: Strasbourg
country: France
facility: CHRU Hôpital de Hautepierre
city: Toulouse
country: France
facility: CHU Toulouse Purpan
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Tours
country: France
facility: CHRU Hôpital Bretonneau
city: Troyes
country: France
facility: Centre hospitalier
city: Vannes
country: France
facility: CH Chubert
city: Aarau
country: Switzerland
facility: Center of Oncology/Hematology and transfusion Medicine, Kantonsspital
city: Basel
country: Switzerland
facility: Universitäts Spital
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli
city: Bern
country: Switzerland
facility: Inselspital
city: Genêve
country: Switzerland
facility: Hôpital cantonal
city: Lausanne
country: Switzerland
facility: CHUV
city: St Gallen
country: Switzerland
facility: Onkologie/Hämatologie Kantonsspital st Gallen
city: Thun
country: Switzerland
facility: Spital Thun-Simmental Onkologiezentrum
city: Zürich
country: Switzerland
facility: Institute of Oncology and Hematology Stadtspital Triemli
Study officials:
affiliation: University Hospital, Toulouse
name: ATTAL Michel, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.