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Maintenance Therapy Using Lenalidomide in Myeloma (IFM2005-02)

Primary Purpose

Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lenalidomide
placebo
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myeloma focused on measuring Myeloma, Revlimid, Maintenance therapy, Autologous Stem Cell Transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • ZNA Middelheim
  • Algemeen Centrumziekenhuis Antwerpen
  • UZA Antwerpen
  • Hôpital Saint Joseph
  • Institut Jules Bordet
  • UCL St Luc
  • Hôpital Saint Joseph
  • Hôpital Jolimont
  • Heilig Hart Ziekenhuis
  • UCL Mont-Godinne
  • CH
  • CHRU
  • CHRU Hôpital du Bocage
  • Centre hospitalier Argenteuil Victor Dupouy
  • Centre hospitalier Duffaut
  • Centre hospitalier de la côte basque
  • Hôpital Jean Minjoz
  • CH
  • Hôpital Avicenne
  • Polyclinique Bordeaux Nord Aquitaine
  • CHRU Hôpital haut Lévêque
  • Hôpial Morvan
  • Polyclinique du Parc
  • Centre Baclesse
  • CH
  • CH William Morey
  • Hôpital Antoine Béclère
  • Hôpital d'instruction des Armées Percy
  • CHRU Hôtel Dieu
  • CH Louis Pasteur
  • CHU Henri Mondor
  • CHRU Dijon
  • Centre hospitalier général
  • CHRU Hôpital Michallon
  • Centre hospitalier départemental
  • CH
  • CHRU Hôpital Claude Huriez
  • Centre hospitalier Bodelio
  • Centre Léon Bérard
  • CHU Hôpital Edouard Herriot
  • Institut Paoli Calmette
  • Hôpital Nord
  • Hôpital Notre Dame de Bon Secours
  • CHRU Hôpitaux de Brabois
  • CHRU Hôtel Dieu
  • Centre Antoine Lacassagne
  • Hôpital Archet
  • Hôpital de l'Archet
  • Hôtel Dieu
  • Hôpital Cochin
  • CHU Hôpital St Antoine
  • Centre hospitalier Lyon Sud
  • CHRU Hôpital Jean Bernard
  • Centre hospitalier de la région d'Annecy
  • Hôpital Debré
  • CHRU Hôpital de Pontchaillou
  • CHRU Hôpital Sud
  • Centre hospitalier de Roanne
  • Centre Henri Becquerel
  • Centre hospitalier de la Réunion
  • Centre hospitalier Yves Le Foll
  • Institut de Cancérologie de la Loire
  • CHRU Hôpital de Hautepierre
  • CHU Toulouse Purpan
  • CHU Toulouse Rangueil
  • CHRU Hôpital Bretonneau
  • Centre hospitalier
  • CH Chubert
  • Center of Oncology/Hematology and transfusion Medicine, Kantonsspital
  • Universitäts Spital
  • Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli
  • Inselspital
  • Hôpital cantonal
  • CHUV
  • Onkologie/Hämatologie Kantonsspital st Gallen
  • Spital Thun-Simmental Onkologiezentrum
  • Institute of Oncology and Hematology Stadtspital Triemli

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo group

lenalidomide group

Arm Description

Administration of oral placebo

Administration of lenalidomide

Outcomes

Primary Outcome Measures

Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2007
Last Updated
April 25, 2019
Sponsor
University Hospital, Toulouse
Collaborators
Intergroupe Francophone du Myelome, Celgene
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1. Study Identification

Unique Protocol Identification Number
NCT00430365
Brief Title
Maintenance Therapy Using Lenalidomide in Myeloma
Acronym
IFM2005-02
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2006 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Intergroupe Francophone du Myelome, Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Maintenance treatment of myeloma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma
Keywords
Myeloma, Revlimid, Maintenance therapy, Autologous Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
614 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Administration of oral placebo
Arm Title
lenalidomide group
Arm Type
Experimental
Arm Description
Administration of lenalidomide
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
REVLIMID
Intervention Description
oral drug
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral placebo
Primary Outcome Measure Information:
Title
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Assess the impact of Revlimid® on the post-transplant complete response rate
Time Frame
2 years
Title
Compare survival without events and overall survival of patients in the lenalidomide arm with the control
Time Frame
2 years
Title
Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.
Time Frame
3 years

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
9850028
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.
Results Reference
background
PubMed Identifier
22571202
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.
Results Reference
derived

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Maintenance Therapy Using Lenalidomide in Myeloma

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