Phase 3 study - Lenalidomide in Patients with Myelodysplastic Syndrome

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Compare The Efficacy And Safety Of Lenalidomide (Revlimid®) Versus Placebo In Subjects With Transfusion-Dependent Anemia Due To IPSS Low Or Intermediate-1 Risk Myelodysplastic Syndromes Without Deletion 5q[31] And Unresponsive Or Refractory To Erythropoiesis-Stimulating Agents

• IRAS ID

  32061

• Contact name

  Paresh Vyas

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2009-011513-24

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  A PHASE 3 STUDY IN SUBJECTS WITH MYELODYSPLASTIC SYNDROMES (MDS) TO COMPARE THE SAFETY AND EFFICACY OF LENALIDOMIDE VERSUS PLACEBO.This is a Phase III, multicentre, double-blind, randomised, placebo-controlled, parallel-group study that compares the efficacy and safety of oral lenalidomide therapy to that of placebo in subjects with transfusion-dependent anaemia due to Myelodysplastic Syndromes (MDS). MDS is a group of diseases in which the production of blood cells by the bone marrow is disrupted. The result is often transfusion-dependant anaemia, an increased risk of infection or haemorrhage, and a potential to progress to acute myeloid leukaemia (AML). In the UK, approximately 3,250 people per year are diagnosed with MDS, and the median age is 70 years. The development of transfusion dependency significantly worsens the survival of patients with MDS. In addition, long-term transfusion dependence has other clinical and economic consequences, including potentially negative impact on patients?? quality of life. This study will investigate whether the study drug will reduce the need for blood transfusions.The expected duration of the study is 6 years, consisting of a 2 year enrolment period, blinded lenalidomide or placebo treatment for up to one year after the last subject is randomised, and an additional 3 years to complete the follow-up period. The study will end after follow-up has been completed for all patients. It is anticipated that enrolment and active treatment for this study will be completed by 31 Dec 2012. Additional information about the health of the study subjects may be collected until 31 Dec 2015.Efficacy assessments will be based on the number and type of blood transfusions administered, complete blood count and peripheral blood smears, bone marrow aspirate or biopsy and patient reported outcome assessments (quality of life questionnaire).Approximately 375 subjects worldwide (Australia, Canada, Europe, Japan, US and perhaps other regions) will take part in this research study (250 subjects on the lenalidomide arm, 125 subjects on the placebo arm).

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/115

• Date of REC Opinion

  29 Jan 2010

• REC opinion

  Further Information Favourable Opinion