NMDSG07A. A multicentre phase II study of the efficacy and safety of lenalidomide in high-risk myeloid disease (high-risk MDS and AML) with a karyotype including del(5q) or monosomy 5 (NMDSG07A). Published.
Sponsor : Nordic MDS group
Principal investigator: Eva Hellström-Lindberg, Lars Möllgård
Primary endpoints: Cytogenetic respons (FISH) after 16 weeks
Status: Final protcol May 9, 2007. Closed for inclusion November, 2009.
Start: October, 2007.
Research support: Nordic Cancer Union, Celgene
Inclusion criteria:
- MDS (IPSS Int-2 or High) or AML (de novo or secondary) with a karyotype including del(5q) or monosomy 5.
Patients could be included if:
- At diagnosis and not considered eligible for induction chemotherapy.
- Refractory to induction therapy
- Relapse and not considered eligible for reinduction.
- Relapse after allogeneic stem cell transplantation and not considered sutiable for reinduciton chmotherapy or other conventional therapy.
Exclusion criteria:
- Patients who are eligible for curative treatment
- Prior therapy with lenalidomide
Treatment: Oral Lenalidomide in increasing doses for 16 weeks
Contact person: Lars Möllgård, lars.mollgard@karolinska.se
Article: Clinical effect of increasing doses of lenalidomide in high-risk myelodysplastic syndrome and acute myeloid leukemia with chromosome 5 abnormalities. Möllgård L, Saft L, Treppendahl MB, Dybedal I, Nørgaard JM, Astermark J, Ejerblad E, Garelius H, Dufva IH, Jansson M, Jädersten M, Kjeldsen L, Linder O, Nilsson L, Vestergaard H, Porwit A, Grønbæk K, Hellström-Lindberg E. 2011, Haematologica; https://www.ncbi.nlm.nih.gov/pubmed/?term=21719884.