Maintenance Therapy Using Lenalidomide in Myeloma
IFM2005-02
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).
2 other identifiers
interventional
614
3 countries
77
Brief Summary
Maintenance treatment of myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2006
Longer than P75 for phase_3
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 31, 2007
CompletedFirst Posted
Study publicly available on registry
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedApril 26, 2019
April 1, 2019
11.3 years
January 31, 2007
April 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
2 years
Secondary Outcomes (3)
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
Study Arms (2)
placebo group
PLACEBO COMPARATORAdministration of oral placebo
lenalidomide group
EXPERIMENTALAdministration of lenalidomide
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- Intergroupe Francophone du Myelomecollaborator
- Celgenecollaborator
Study Sites (77)
ZNA Middelheim
Antwerp, 2020, Belgium
Algemeen Centrumziekenhuis Antwerpen
Antwerp, 2060, Belgium
UZA Antwerpen
Antwerp, 2650, Belgium
Hôpital Saint Joseph
Arlon, 6700, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
UCL St Luc
Brussels, 1200, Belgium
Hôpital Saint Joseph
Gilly, 6060, Belgium
Hôpital Jolimont
Haine-Saint-Paul, 7100, Belgium
Heilig Hart Ziekenhuis
Roeselare, 8800, Belgium
UCL Mont-Godinne
Yvoir, 5530, Belgium
CH
Aix-en-Provence, 13616, France
CHRU
Amiens, 80054, France
CHRU Hôpital du Bocage
Angers, 49033, France
Centre hospitalier Argenteuil Victor Dupouy
Argenteuil, 95100, France
Centre hospitalier Duffaut
Avignon, 84902, France
Centre hospitalier de la côte basque
Bayonne, 64109, France
Hôpital Jean Minjoz
Besançon, 25030, France
CH
Blois, 41016, France
Hôpital Avicenne
Bobigny, 93009, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300, France
CHRU Hôpital haut Lévêque
Bordeaux, 33604, France
Hôpial Morvan
Brest, 29609, France
Polyclinique du Parc
Caen, 14033, France
Centre Baclesse
Caen, 14076, France
CH
Chartres, 28018, France
CH William Morey
Châlon-sur-Saône, 71321, France
Hôpital Antoine Béclère
Clamart, 92141, France
Hôpital d'instruction des Armées Percy
Clamart, 92141, France
CHRU Hôtel Dieu
Clermont-Ferrand, 63003, France
CH Louis Pasteur
Colmar, 68024, France
CHU Henri Mondor
Créteil, 94010, France
CHRU Dijon
Dijon, 21000, France
Centre hospitalier général
Dunkirk, 59385, France
CHRU Hôpital Michallon
Grenoble, 38043, France
Centre hospitalier départemental
La Roche-sur-Yon, 85025, France
CH
Le Mans, 72037, France
CHRU Hôpital Claude Huriez
Lille, 59037, France
Centre hospitalier Bodelio
Lorient, 56322, France
Centre Léon Bérard
Lyon, 69008, France
CHU Hôpital Edouard Herriot
Lyon, 69437, France
Institut Paoli Calmette
Marseille, 13273, France
Hôpital Nord
Marseille, 13915, France
Hôpital Notre Dame de Bon Secours
Metz, 57038, France
CHRU Hôpitaux de Brabois
Nancy, 54511, France
CHRU Hôtel Dieu
Nantes, 44093, France
Centre Antoine Lacassagne
Nice, 06050, France
Hôpital Archet
Nice, 06202, France
Hôpital de l'Archet
Nice, 06202, France
Hôtel Dieu
Paris, 75004, France
Hôpital Cochin
Paris, 75014, France
CHU Hôpital St Antoine
Paris, 75571, France
Centre hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHRU Hôpital Jean Bernard
Poitiers, 86021, France
Centre hospitalier de la région d'Annecy
Pringy, 74374, France
Hôpital Debré
Reims, 51092, France
CHRU Hôpital de Pontchaillou
Rennes, 35033, France
CHRU Hôpital Sud
Rennes, 35056, France
Centre hospitalier de Roanne
Roanne, 42328, France
Centre Henri Becquerel
Rouen, 76038, France
Centre hospitalier Yves Le Foll
Saint-Brieuc, 22027, France
Centre hospitalier de la Réunion
Saint-Denis, 97405, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271, France
CHRU Hôpital de Hautepierre
Strasbourg, 67098, France
CHU Toulouse Purpan
Toulouse, France
CHU Toulouse Rangueil
Toulouse, France
CHRU Hôpital Bretonneau
Tours, 37044, France
Centre hospitalier
Troyes, 10003, France
CH Chubert
Vannes, 56017, France
Center of Oncology/Hematology and transfusion Medicine, Kantonsspital
Aarau, 5001, Switzerland
Universitäts Spital
Basel, 4031, Switzerland
Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli
Bellinzona, 6500, Switzerland
Inselspital
Bern, 3010, Switzerland
Hôpital cantonal
Genêve, 1211, Switzerland
CHUV
Lausanne, 1011, Switzerland
Onkologie/Hämatologie Kantonsspital st Gallen
Sankt Gallen, 9007, Switzerland
Spital Thun-Simmental Onkologiezentrum
Thun, 3600, Switzerland
Institute of Oncology and Hematology Stadtspital Triemli
Zurich, 8063, Switzerland
Related Publications (2)
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.
PMID: 9850028BACKGROUNDAttal 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.
PMID: 22571202DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ATTAL Michel, Pr
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2007
First Posted
February 1, 2007
Study Start
June 1, 2006
Primary Completion
September 1, 2017
Study Completion
September 1, 2018
Last Updated
April 26, 2019
Record last verified: 2019-04