myelodysplastic syndrome MedDRA version: 21.1 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LENALIDOMIDE
CAS Number: 191732-72-6
Current Sponsor code: n.a.
Concentration unit: mg milligram(s)
Concentration type: equ
Sponsors
HOVON Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with MDS classified as - RA, RARS and RAEB (with 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: - Severe cardiac, pulmonary, neurologic, metabolic or psychiatric diseases or active malignancies. - Anemia due to other causes than MDS including iron, B12 and folate deficiencies, auto-immune hemolysis and/or paroxysmal noctural hemoglobinuria (PNH) - Hypoplastic MDS - High predictive score (score 0 or 1) to respond on standard treatment with Epo/G-CSF according to guidelines - Active uncontrolled infection - Absolute neutrophil count (ANC) < 0.5x109/l - Patients dependent on platelet transfusions or with platelet counts < 25x109/l or patients with active bleeding - Patients treated with biological response modifiers (i.e. growth factors, immunosuppressive agents and/or chemotherapy) within 1 month prior to randomization - Lactating women - Prior treatment with lenalidomide - Prior CTCAE = grade 3 allergic reaction/hypersensitivity to thalidomide - Prior CTCAE = grade 3 rash/blistering while taking thalidomide - Prior CTCAE = grade 3 allergic/hypersensitivity to Epo and/or G-CSF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of lenalidomide (RevlimidTM) in low/int-1 risk MDS with or without a treatment with Epo (NeoRecormonTM)/G-CSF (NeupogenTM) in terms of hematological improvement (HI) as defined by the modified response criteria of the IWG for MDS.;Secondary Objective: - To evaluate the safety and tolerability of lenalidomide (RevlimidTM) in low/int-1 risk MDS with or without Epo (NeoRecormonTM)/G-CSF (NeupogenTM) - Time-to-HI and duration-of-HI - The number of given treatment cycles per patient and for arm B the number of patients receiving Epo and/or G-CSF - The response rate (in terms of CR, PR, including cytogenetic response according to the modified response criteria of the IWG for MDS) - Progression-Free-Survival (i.e. time from registration to disease progression, including progression to leukemia, or death from any cause) - Transfusion requirements of red blood cells ;Primary end point(s): -Primary endpoint • Hematological improvement (HI) according to IWG 2006 criteria ;Timepoint(s) of evaluation of this end point: Hematological improvement (HI) will be assessed on day 1 of every cycle starting form day 1 of cycle 2. HI will be assessed for each cell line. Dependent on the relevant pre-treatment parameter e.g. Hb, platelet count or ANC, HI will be assessed and responses must last at least for 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints • Adverse events of CTCAE = grade 2 (see appendix E) • Time-to-HI and duration-of-HI (i.e. time from HI to relapse after HI or death from any cause) • Number of given treatment cycles per patient, and especially for arm B the number of patients receiving Epo and/or G-CSF • Response rate (in terms of CR, PR, including cytogenetic response according to the modified response criteria of the IWG for MDS [40], appendix C) • Progression-free-survival, i.e. time from registration to relapse, disease progression (as defined in appendix C) or death from any cause • Leukemic evolution. The risk of leukemic evolution will be calculated with competing risk death without previous evolution • Number of transfusions of red blood cells and duration of RBC transfusion independence ;Timepoint(s) of evaluation of this end point: Hematological improvement (HI) will be assessed on day 1 of every cycle starting form day 1 of cycle 2. Disease and cytogenetic response should be assessed at month 6 and 12 or at any indication (e.g. off treatment or (signs of) progressive disease). | — |
Countries
Netherlands
Contacts
Public ContactHOVON Data Center
Erasmus MC
Outcome results
None listed