Trial | NCT00430365  Report issue

Title

Maintenance Therapy Using Lenalidomide in Myeloma
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).

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lenalidomide ...

  • Study Participants

    614
Maintenance treatment of myeloma.
Study Started
Jun 30
2006
Primary Completion
Sep 30
2017
Study Completion
Sep 30
2018
Last Update
Apr 26
2019

Drug lenalidomide

oral drug

  • Other names: REVLIMID

Drug placebo

oral placebo

placebo group Placebo Comparator

Administration of oral placebo

lenalidomide group Experimental

Administration of lenalidomide

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.
No Results Posted