Maintenance Therapy Using Lenalidomide in Myeloma

Phase 3

Completed

• Conditions: Myeloma
• Interventions: Drug: placebo; Drug: lenalidomide

• Registration Number: NCT00430365
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

Maintenance treatment of myeloma.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Primary Completion: 2017-09
• Study Completion: 2018-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 614

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	placebo	Administration of oral placebo
lenalidomide group	lenalidomide	Administration of lenalidomide

Primary Outcome Measures

Name	Time	Method
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.	2 years

Secondary Outcome Measures

Name	Time	Method
Assess the impact of Revlimid® on the post-transplant complete response rate	2 years
Compare survival without events and overall survival of patients in the lenalidomide arm with the control	2 years
Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.	3 years

Trial Locations

Locations (72)

CHRU Hôpital Bretonneau; 🇫🇷 Tours, France

Centre hospitalier; 🇫🇷 Troyes, France

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

Algemeen Centrumziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

UZA Antwerpen; 🇧🇪 Antwerpen, Belgium

Hôpital Saint Joseph; 🇧🇪 Gilly, Belgium

CH; 🇫🇷 Le Mans, France

CHRU; 🇫🇷 Amiens, 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

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Hôpial Morvan; 🇫🇷 Brest, France

Polyclinique du Parc; 🇫🇷 Caen, France

CH William Morey; 🇫🇷 Châlon-sur-Saône, France

Centre Baclesse; 🇫🇷 Caen, France

Hôpital d'instruction des Armées Percy; 🇫🇷 Clamart, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

CHRU Hôtel Dieu; 🇫🇷 Nantes, France

CH Louis Pasteur; 🇫🇷 Colmar, France

CHU Henri Mondor; 🇫🇷 Créteil, France

CHRU Dijon; 🇫🇷 Dijon, France

Centre hospitalier général; 🇫🇷 Dunkerque, France

Centre hospitalier départemental; 🇫🇷 La Roche sur Yon, France

CHRU Hôpital Claude Huriez; 🇫🇷 Lille, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CHU Hôpital Edouard Herriot; 🇫🇷 Lyon, France

Hôpital Nord; 🇫🇷 Marseille, France

CHRU Hôpitaux de Brabois; 🇫🇷 Nancy, France

Hôpital Archet; 🇫🇷 Nice, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Hôpital de l'Archet; 🇫🇷 Nice, 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 hospitalier de la Réunion; 🇫🇷 Saint-Denis, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre hospitalier Yves Le Foll; 🇫🇷 St Brieuc, France

CHRU Hôpital de Hautepierre; 🇫🇷 Strasbourg, France

CHU Toulouse Purpan; 🇫🇷 Toulouse, France

CHU Toulouse Rangueil; 🇫🇷 Toulouse, 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; 🇨🇭 St Gallen, Switzerland

Spital Thun-Simmental Onkologiezentrum; 🇨🇭 Thun, Switzerland

Institute of Oncology and Hematology Stadtspital Triemli; 🇨🇭 Zürich, Switzerland

CHRU Hôpital du Bocage; 🇫🇷 Angers, France

Hôpital Avicenne; 🇫🇷 Bobigny, France

CHRU Hôpital haut Lévêque; 🇫🇷 Bordeaux, France

CHRU Hôpital Michallon; 🇫🇷 Grenoble, France

Centre hospitalier Bodelio; 🇫🇷 Lorient, France

Institut Paoli Calmette; 🇫🇷 Marseille, France

Hôpital Notre Dame de Bon Secours; 🇫🇷 Metz, France

Institut de Cancérologie de la Loire; 🇫🇷 St-Priest-en-Jarez, France

CHU Hôpital St Antoine; 🇫🇷 Paris, France

Hôpital Jolimont; 🇧🇪 Haine Saint Paul, Belgium

UCL Mont-Godinne; 🇧🇪 Yvoir, Belgium

Institut Jules Bordet; 🇧🇪 Bruxelles, Belgium

Heilig Hart Ziekenhuis; 🇧🇪 Roeselare, Belgium

UCL St Luc; 🇧🇪 Bruxelles, Belgium