Maintenance Therapy Using Lenalidomide in Myeloma (IFM2005-02)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Intergroupe Francophone du Myelome
Celgene Corporation
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00430365
First received: January 31, 2007
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

Maintenance treatment of myeloma.


Condition Intervention Phase
Myeloma
Drug: lenalidomide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess the impact of Revlimid® on the post-transplant complete response rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Compare survival without events and overall survival of patients in the lenalidomide arm with the control [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 614
Study Start Date: June 2006
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Administration of oral placebo
Drug: placebo
oral placebo
Experimental: 1
Administration of lenalidomide
Drug: lenalidomide
oral drug
Other Name: REVLIMID

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430365

  Hide Study Locations
Locations
Belgium
UZA Antwerpen
Antwerpen, Belgium, 2650
Algemeen Centrumziekenhuis Antwerpen
Antwerpen, Belgium, 2060
ZNA Middelheim
Antwerpen, Belgium, 2020
Hôpital Saint Joseph
Arlon, Belgium, 6700
UCL St Luc
Bruxelles, Belgium, 1200
Institut Jules Bordet
Bruxelles, Belgium, 1000
Hôpital Saint Joseph
Gilly, Belgium, 6060
Hôpital Jolimont
Haine Saint Paul, Belgium, 7100
Heilig Hart Ziekenhuis
Roeselare, Belgium, 8800
UCL Mont-Godinne
Yvoir, Belgium, 5530
France
CH
Aix-en-Provence, France, 13616
CHRU
Amiens, France, 80054
CHRU Hôpital du Bocage
Angers, France, 49033
Centre hospitalier Argenteuil Victor Dupouy
Argenteuil, France, 95100
Centre hospitalier Duffaut
Avignon, France, 84902
Centre hospitalier de la côte basque
Bayonne, France, 64109
Hôpital Jean Minjoz
Besançon, France, 25030
CH
Blois, France, 41016
Hôpital Avicenne
Bobigny, France, 93009
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
CHRU Hôpital haut Lévêque
Bordeaux - Pessac, France, 33604
Hôpial Morvan
Brest, France, 29609
Centre Baclesse
Caen, France, 14076
Polyclinique du Parc
Caen, France, 14033
CH
Chartres, France, 28018
CH William Morey
Châlon-sur-Saône, France, 71321
Hôpital Antoine Béclère
Clamart, France, 92141
Hôpital d'instruction des Armées Percy
Clamart, France, 92141
CHRU Hôtel Dieu
Clermont Ferrand, France, 63003
CH Louis Pasteur
Colmar, France, 68024
CHU Henri Mondor
Créteil, France, 94010
CHRU Dijon - Hôpital des enfants
Dijon, France, 21000
Centre hospitalier général
Dunkerque, France, 59385
CHRU Hôpital Michallon
Grenoble, France, 38043
Centre hospitalier départemental
La Roche sur Yon, France, 85025
CH
Le Mans, France, 72037
CHRU Hôpital Claude Huriez
Lille, France, 59037
Centre hospitalier Bodelio
Lorient, France, 56322
Centre Léon Bérard
Lyon, France, 69008
CHU Hôpital Edouard Herriot
Lyon, France, 69437
Institut Paoli Calmette
Marseille, France, 13273
Hôpital Nord
Marseille, France, 13915
Hôpital Notre Dame de Bon Secours
Metz, France, 57038
CHRU Hôtel Dieu
Nantes, France, 44093
Hôpital Archet
Nice, France, 06202
Hôpital de l'Archet
Nice, France, 06202
Centre Antoine Lacassagne
Nice, France, 06050
CHU Hôpital St Antoine
Paris, France, 75571
Hôtel Dieu
Paris, France, 75004
Hôpital Cochin
Paris, France, 75014
Centre hospitalier Lyon Sud
Pierre Bénite, France, 69495
CHRU Hôpital Jean Bernard
Poitiers, France, 86021
Centre hospitalier de la région d'Annecy
Pringy, France, 74374
Hôpital Debré
Reims, France, 51092
CHRU Hôpital dePontchaillou
Rennes, France, 35033
CHRU Hôpital Sud
Rennes, France, 35056
Centre hospitalier de Roanne
Roanne, France, 42328
Centre Henri Becquerel
Rouen, France, 76038
Centre hospitalier Yves Le Foll
St Brieuc, France, 22027
Centre hospitalier départemental
St Denis de la Réunion, France, 97405
Institut de Cancérologie de la Loire
St-Priest-en-Jarez, France, 42271
CHRU Hôpital de Hautepierre
Strasbourg, France, 67098
CHU Toulouse Rangueil
Toulouse, France
CHU Toulouse Purpan
Toulouse, France
CHRU Hôpital Bretonneau
Tours, France, 37044
Centre hospitalier
Troyes, France, 10003
CHRU Hôpitaux de Brabois
Vandoeuvre, France, 54511
CH Chubert
Vannes, France, 56017
Switzerland
Center of Oncology/Hematology and transfusion Medicine, Kantonsspital
Aarau, Switzerland, 5001
Universitäts Spital
Basel, Switzerland, 4031
Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli
Bellinzona, Switzerland, 6500
Inselspital
Bern, Switzerland, 3010
Hôpital cantonal
Genêve, Switzerland, 1211
CHUV
Lausanne, Switzerland, 1011
Onkologie/Hämatologie Kantonsspital st Gallen
St Gallen, Switzerland, 9007
Spital Thun-Simmental Onkologiezentrum
Thun, Switzerland, 3600
Institute of Oncology and Hematology Stadtspital Triemli
Zürich, Switzerland, 8063
Sponsors and Collaborators
University Hospital, Toulouse
Intergroupe Francophone du Myelome
Celgene Corporation
Investigators
Principal Investigator: ATTAL Michel, Pr University Hospital, Toulouse
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00430365     History of Changes
Other Study ID Numbers: 0400401, French PHRC
Study First Received: January 31, 2007
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Myeloma
Revlimid
Maintenance therapy
Autologous Stem Cell Transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014