NCT00424229

Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]

Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (planned)
• Sponsor: Groupe Francophone des Myelodysplasies · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System \[IPSS\]) MDS with a deletion (del) 5q\[31\]

Detailed description

Subjects meeting all inclusion and exclusion criteria will receive lenalidomide lenalidomide will be administered at 10 mg (two 5 mg capsules) once daily on Days 1-21, every 4 weeks. Bone marrow aspirate (baseline and during the course of the study at week 8, 16, 32, 52 and when clinically indicated/for assessment of disease progression) evaluations Subjects may participate in the study for up to 52 weeks ( in patients still responding after 52 weeks, the drug wil continue to be supplied).

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	LENALIDOMIDE

Timeline

• Start date: 2006-10-01
• Completion: 2008-10-01
• First posted: 2007-01-18
• Last updated: 2007-03-12

Locations

11 sites across 1 country: France