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About
The purpose of this study is to determine the safety of lenalidomide and markers for disease progression in the treatment of IPSS low- or intermediate-1 risk MDS with isolated del5q.
Full description
Lenalidomide has been successfully used in patients with MDS in several studies. A small proportion of patients with MDS and del(5q) developed leukemia while treated with Lenalidomide. Up to now it is unknown what patients are at risk to progress while being treated with Lenalidomid. Therefore it is planned to examine not only the traditional clinical parameters like disease status and proportion of blasts, but also cytogenetic findings, gene expression, antiangiogenic effect, marrow fibrosis, mesenchymal stem cell as well as mitochondrial DNA mutation at baseline and in the course of the study performed by central laboratories. Moreover, long-term data are required, e.g., with regard to the development of AML. Therefore, it is planned to collect data from all patients with MDS and del 5q (isolated, blast count <5%) in whom treatment with lenalidomide is the best therapeutic option according to the investigator's assessment in a structured fashion.
Enrollment
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Inclusion criteria
Must understand and voluntarily sign an informed consent form
Age ≥ 18 years at the time of signing the informed consent form.
Must be able to adhere to the study visit schedule and other protocol requirements
Cytologically/histologically confirmed diagnosis of MDS with del 5q (isolated, blast count <5%), IPSS low or intermediate-1.
Transfusion dependency with at least 1 concentrates of erythrocytes within 8 weeks prior to first administration of study drug.
Start of treatment with lenalidomide is the best therapeutic option for the patient according to the investigator's assessment There are - apart from individual cases with erythropoetin level lower than 500 U/l and allogeneic transplantation for younger patients - no authorized alternative treatment options. Chemotherapy with low dose cytosine arabinoside may result in hematologic improvement. However, concerning the risk-benefit-assessment this chemotherapy is more unfavorable than lenalidomide due to cytopenia and mutagenic effects.
Female subjects of childbearing potential must:
(*) Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of VTE continues for 4 to 6 weeks after stopping combined oral contraception.
(**) Prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection
Male subjects must
All subjects must
Exclusion criteria
Pregnant or lactating females
IPSS intermediate-2 or high-risk
Proliferative (WBC ≥ 12 x 109/L) CMML
Any of the following laboratory abnormalities:
Prior ≥ grade-2 NCI CTCAE allergic reaction to thalidomide
Prior desquamating (blistering) rash while taking thalidomide
Neuropathy ≥ grade 2
Clinically significant anemia owing 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)
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
Concomitant use of androgens (exception: treatment of hypogonadism)
Concomitant use of specific treatments for MDS
Known HIV-1 positivity
Participation in another clinical study in the 4 weeks prior to enrollment or during this study
Prior treatment with lenalidomide
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/she participates in the study.
Primary purpose
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Interventional model
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91 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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