drugset / Trial / NCT00430365
Maintenance Therapy Using Lenalidomide in Myeloma
Phase 3
Completed
614 enrolled
University Hospital, Toulouse
Celgene Corporation · collabIntergroupe Francophone du Myelome · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Maintenance treatment of myeloma.
Timeline
- Start
- 2006-06
- Primary completion
- 2017-09
- Completion
- 2018-09
Outcome
Met primary endpoint
paper Lenalidomide maintenance therapy improved median progression-free survival (41 months, vs. 23 months with placebo; hazard ratio, 0.50; P<0.001). PMID 22571202 ↗
Publications
- Background 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 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 15 mg | Oral |