MyelomaPhase 3IFM2005-02NCT00430365
Maintenance Therapy Using Lenalidomide in Myeloma
A Phase 3 study testing lenalidomide in people with Myeloma, run by University Hospital, Toulouse at 77 sites in 3 countries.
Trial summary
Maintenance treatment of myeloma. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myeloma
- What is being tested?
- lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 614 participants
- Where
- 77 sitesin 3 countries
- Study dates
- Jun 2006to Sep 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
77 sites in 3 countries.
77 sites in 3 countries
France58 sites
CH
Aix-en-Provence, 13616
CHRU
Amiens, 80054
CHRU Hôpital du Bocage
Angers, 49033
Centre hospitalier Argenteuil Victor Dupouy
Argenteuil, 95100
Centre hospitalier Duffaut
Avignon, 84902
Centre hospitalier de la côte basque
Bayonne, 64109
Hôpital Jean Minjoz
Besançon, 25030
CH
Blois, 41016
Hôpital Avicenne
Bobigny, 93009
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
CHRU Hôpital haut Lévêque
Bordeaux, 33604
Hôpial Morvan
Brest, 29609
Polyclinique du Parc
Caen, 14033
Centre Baclesse
Caen, 14076
CH William Morey
Châlon-sur-Saône, 71321
CH
Chartres, 28018
Hôpital Antoine Béclère
Clamart, 92141
Hôpital d'instruction des Armées Percy
Clamart, 92141
CHRU Hôtel Dieu
Clermont-Ferrand, 63003
CH Louis Pasteur
Colmar, 68024
CHU Henri Mondor
Créteil, 94010
CHRU Dijon
Dijon, 21000
Centre hospitalier général
Dunkirk, 59385
CHRU Hôpital Michallon
Grenoble, 38043
Centre hospitalier départemental
La Roche-sur-Yon, 85025
CH
Le Mans, 72037
CHRU Hôpital Claude Huriez
Lille, 59037
Centre hospitalier Bodelio
Lorient, 56322
Centre Léon Bérard
Lyon, 69008
CHU Hôpital Edouard Herriot
Lyon, 69437
Institut Paoli Calmette
Marseille, 13273
Hôpital Nord
Marseille, 13915
Hôpital Notre Dame de Bon Secours
Metz, 57038
CHRU Hôpitaux de Brabois
Nancy, 54511
CHRU Hôtel Dieu
Nantes, 44093
Centre Antoine Lacassagne
Nice, 06050
Hôpital Archet
Nice, 06202
Hôpital de l'Archet
Nice, 06202
Hôtel Dieu
Paris, 75004
Hôpital Cochin
Paris, 75014
CHU Hôpital St Antoine
Paris, 75571
Centre hospitalier Lyon Sud
Pierre-Bénite, 69495
CHRU Hôpital Jean Bernard
Poitiers, 86021
Centre hospitalier de la région d'Annecy
Pringy, 74374
Hôpital Debré
Reims, 51092
CHRU Hôpital de Pontchaillou
Rennes, 35033
CHRU Hôpital Sud
Rennes, 35056
Centre hospitalier de Roanne
Roanne, 42328
Centre Henri Becquerel
Rouen, 76038
Centre hospitalier Yves Le Foll
Saint-Brieuc, 22027
Centre hospitalier de la Réunion
Saint-Denis, 97405
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42271
CHRU Hôpital de Hautepierre
Strasbourg, 67098
CHU Toulouse Purpan
Toulouse
CHU Toulouse Rangueil
Toulouse
CHRU Hôpital Bretonneau
Tours, 37044
Centre hospitalier
Troyes, 10003
CH Chubert
Vannes, 56017
Belgium10 sites
ZNA Middelheim
Antwerp, 2020
Algemeen Centrumziekenhuis Antwerpen
Antwerp, 2060
UZA Antwerpen
Antwerp, 2650
Hôpital Saint Joseph
Arlon, 6700
Institut Jules Bordet
Brussels, 1000
UCL St Luc
Brussels, 1200
Hôpital Saint Joseph
Gilly, 6060
Hôpital Jolimont
Haine-Saint-Paul, 7100
Heilig Hart Ziekenhuis
Roeselare, 8800
UCL Mont-Godinne
Yvoir, 5530
Switzerland9 sites
Center of Oncology/Hematology and transfusion Medicine, Kantonsspital
Aarau, 5001
Universitäts Spital
Basel, 4031
Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli
Bellinzona, 6500
Inselspital
Bern, 3010
Hôpital cantonal
Genêve, 1211
CHUV
Lausanne, 1011
Onkologie/Hämatologie Kantonsspital st Gallen
Sankt Gallen, 9007
Spital Thun-Simmental Onkologiezentrum
Thun, 3600
Institute of Oncology and Hematology Stadtspital Triemli
Zurich, 8063
About this study
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).
Maintenance treatment of myeloma.
- Conditions
- Myeloma
- Being tested
- lenalidomide, placebo
- Keywords
- Myeloma, Revlimid, Maintenance therapy, Autologous Stem Cell Transplantation
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Also called REVLIMID
oral drug
placeboDrug
oral placebo
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | Administration of oral placebo Receives: Drug: placebo |
| lenalidomide group | Experimental | Administration of lenalidomide Receives: Drug: lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
Measured: 2 years
Secondary outcomes (3)
Assess the impact of Revlimid® on the post-transplant complete response rate
Measured: 2 years
Compare survival without events and overall survival of patients in the lenalidomide arm with the control
Measured: 2 years
Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startJun 2006
- Primary completionSep 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Intergroupe Francophone du Myelome, Celgene
- Responsible party
- Sponsor
- Investigators
- ATTAL Michel, Pr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430365
- Sponsor's protocol ID
- 0400401
- Other IDs
- 2005-001554-24, 2005
- Acronym
- IFM2005-02
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2007
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9850028Attal 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.
PubMed 22571202
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00430365
- Acronym / sponsor ID
- IFM2005-02 / 0400401
- Conditions
- Myeloma
- Keywords
- Myeloma, Revlimid, Maintenance therapy, Autologous Stem Cell Transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Intergroupe Francophone du Myelome, Celgene
- Study start
- Jun 2006 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Maintenance treatment of myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Drug: placeboAdministration of oral placebo |
| lenalidomide group | Experimental | Drug: lenalidomideAdministration of lenalidomide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenalidomideAlso: REVLIMIDoral drug | Drug | lenalidomide group |
| placebooral placebo | Drug | placebo group |
Primary outcome
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response.
Time frame: 2 years
3 secondary outcomes
Assess the impact of Revlimid® on the post-transplant complete response rate
Time frame: 2 years
Compare survival without events and overall survival of patients in the lenalidomide arm with the control
Time frame: 2 years
Evaluate the long-term tolerance of Revlimid® in post-transplant maintenance therapy.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 9850028Combination 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 publication: PubMed 22571202Attal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ATTAL Michel, Pr principal investigator
University Hospital, Toulouse
77 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lenalidomide in people with Myeloma, run by University Hospital, Toulouse at 77 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in France, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the efficacy of Revlimid® at prolonging the duration of the post-transplant response. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00430365, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.