Myelodysplastic syndrome (MDS)
Conditions
Interventions
Arm A: 12 cycles of lenalidomide, followed by lenalidomide maintenance cycles.
Arm B: 4 cycles of lenalidomide, followed by 4 cycles of lenalidomide +/- Epo
followed by 4 cycles of lenalidomide +/- Epo +/- G-CSF, followed by lenalidomide +/- Epo +/- G-CSF maintenance cycles.
Sponsors
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Postbus 2040; 3000 CA Rotterdam; Tel: +31 10 704 1560 Fax: +31 10 704 1028; e-mail: hdc@erasmusmc.nl
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with MDS classified as: RA, RARS and RAEB (with = 18 years; 4. WHO performance status 0-2; 5. Patient not previously treated with Epo/G-CSF, or failure of response or relapse after hematological improvement or disease progression to maximal RAEB-1 after previous therapy with Epo/G-CSF; 6. Serum creatinin 200 U/l or <= 200 U/l if failure of response or loss of hematological improvement or disease progression to maximal RAEB-1 after prior standard therapy with Epo/G-CSF; Epo/G-CSF should be stopped at least 1 month before randomization.
Exclusion criteria
Exclusion criteria: 1. Severe cardiac, pulmonary, neurologic, metabolic or psychiatric diseases or active malignancies; 2. Anemia due to other causes than MDS including iron, B12 and folate deficiencies, auto-immune hemolysis and/or paroxysmal noctural hemoglobinuria (PNH); 3. Hypoplastic MDS; 4. High predictive score (score 0 or 1) to respond on standard treatment with Epo/G-CSF according to guidelines; 5. Active uncontrolled infection; 6. Absolute neutrophil count (ANC) = grade 3 allergic reaction/hypersensitivity to thalidomide; 14. Prior CTCAE >= grade 3 rash/blistering while taking thalidomide 15. Prior CTCAE >= grade 3 allergic/hypersensitivity to Epo and/or G-CSF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematological improvement (HI) according to IWG 2006 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events of CTCAE >= grade 2; 2. Time-to-HI and duration-of-HI; 3. Number of given treatment cycles per patient, and especially for arm B the number of patients receiving Epo and/or G-CSF; 4. Response rate (in terms of CR, PR, including cytogenetic response according to the modified response criteria of the IWG for MDS). 5. Progression-free-survival; 6. Leukemic evolution. The risk of leukemic evolution will be calculated with competing risk death without previous evolution 7. Number of transfusions of red blood cells and duration of RBC transfusion independence. | — |
Contacts
Public ContactA.A. Loosdrecht, van de
VU University Medical Center; Department of Hematology; Postbus 7057; 1007 MB Amsterdam
Outcome results
None listed