Myelodysplastic syndrome (MDS) is a clonal disease of the bone marrow stem cells. The disease is frequent/asociated with cytopenia and/or blastosis. an evolution to an acute leukemia is not frequent (30%). Treatments are very disapointing especially for high risk MDS. The pronossis mainly depens on blastosis, cytopenia and cytogenetic abnormalities but the disease is typically uncurable ( expect BMT).
Conditions
Interventions
Trade Name: Lenalidomide
Product Name: Lenalidomide
Pharmaceutical Form: Capsule*
INN or Proposed INN: 2933.79
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Groupe Français des myélodysplasies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years at the time of signing the informed consent form 2. Must understand and voluntarily sign an informed consent form 3. Must be able to adhere to the study visit schedule and other protocol requirements 4. Concurrent corticosteroids used for medical conditions other than MDS allowed provided subject is on a stable or decreasing dose for = 1 week prior to study entry 5. Prior thalidomide allowed 6. Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC 25,000u/L 9. Absolute Neutrophil count > 500u/L ? (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating females. 2. Prior therapy with lenalidomide 3. Proliferative (WBC = 13,000/mL) chronic myelomonocytic leukemia (CMML) 4. Prior = grade-2 NCI CTCAE (v 3.0) allergic reaction to thalidomide 5. Prior desquamating (blistering) rash while taking thalidomide 6. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for = 3 years 7. Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days 8. Less than 6 months since prior allogeneic bone marrow transplantation 9. Less than 3 months since prior autologous bone marrow or stem cell transplantation 10. Recombinant human erythropoietin (rHuEPO) therapy received within 28 days 11. Use of androgens other than for treating hypogonadism 12. Known HIV-1 positivity 13. Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study 14. Any of the following laboratory abnormalities: ? Serum creatinine > 2.0 mg/dL (177 mmol/L) ? Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN) ? Serum total bilirubin > 1.5 mg/dL,: 15. Subjects with = grade-2 neuropathy 16. Clinically significant anemia due to iron, B12, or folate deficiencies, or autoimmune or hereditary hemolysis or gastrointestinal bleeding (the subject must have a marrow aspirate that is evaluable for storage iron)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate response to lenalidomide (according to IWG criteria) in adult MDS with deletion (del) 5q[31] cytogenetic abnormality and intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS ;Secondary Objective: Evaluate duration of response, progression to AML, survival and safety of lenalidomide in subjects with intermediate-2-risk or high risk MDS associated with a del 5q [31].;Primary end point(s): Primary: i ncidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response. Secondary: Duration of responses ie :CR, PR, major HI, ( HI-E, HI-N,or HI-P),and cytogenetic response) from response achievement Time to progression to AML from inclusion Survival from inclusion Safety (type, frequency, and severity [National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0] of adverse events (AEs), and relationship of AEs to lenalidomide. | — |
Countries
Belgium
Outcome results
None listed