NMDS Group logo

NMDS Group

Sponsor: Nordic MDS group

Principal investigator: Lars Möllgård

Co-principal investigator: Eva Hellström Lindberg

Primary endpoint: Hematologic response after 6 cycles of azacitidine or azacitidine+lenalidomide treatment

Co-primary endpoint: Cytogenetic response (FISH) after 6 cycles of azacitidine or azacitidine+lenalidomide treatment

Status:  Final Protocol June, 2011.

Start: Sweden; March, 2012. Denmark; August, 2012. Norway; July 2013. Finland; October 2014.

Research support: Celgene

Inclusion critera:

  • MDS (IPSS Int-2 or High) or AML (multilineage dysplasia and 20-30 % blasts) with a karyotype including del(5q).

Exclusion criteria:

  • Eligible for upfront allogeneic SCT without prior chemotherapy including azacytidine
  • Prior therapy with lenalidomide

Treatment: Patients will be randomized to azacitidine (Arm A) or azacitidine + lenalidomide (Arm B) in increasing doses for 6 cycles.

Target: 72 randomized patients

Number of patients randomized now: 72

Contact persons: 

Bengt Rasmussen, This email address is being protected from spambots. You need JavaScript enabled to view it.

Lars Möllgård, This email address is being protected from spambots. You need JavaScript enabled to view it.