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• W2040604017 abstract "Thalidomide, a derivate of glutamic acid, is increasingly used in patients with multiple myeloma (MM) (Singhal et al, 1999). It has proved to be active in up to one-third of patients with refractory or relapsing MM. Renal failure is a frequent complication of MM that is present in 50% of newly diagnosed patients (Kyle et al, 2003). Data regarding thalidomide pharmacokinetics and tolerance in patients with renal failure are lacking. We report our early experience regarding the use of thalidomide in seven patients with MM and variable degrees of renal insufficiency. Seven patients (three females and four males) diagnosed with MM between 1996 and 2001 received treatment with thalidomide (Laboratoire Laphal, Paris, France). Four patients received a combination of steroids and thalidomide. The main characteristics of these patients before and during treatment are summarized in Table I. Patient 7 presented with severe hyperkalaemia (>8 mmol/l) on two occasions during therapy with 400 mg/d thalidomide. However, hyperkalaemia recurred when the thalidomide dosage was tapered to 100 mg/d. The measurement of thalidomide trough plasma concentration using a high-performance liquid chromatography method as described previously (Eriksson et al, 1992) was performed in each patient on one to four occasions. Thalidomide trough plasma level ranged from 0·39 μg/ml to 1·48 μg/ml. Serial plasma thalidomide concentration measurements were performed in patient 2 during a haemodialysis session (DiCEA, Baxter, France; cellulosic membrane, surface area = 1·70 m2, ultrafiltration coefficient: 12·5). Serum thalidomide concentrations were 1·48 μg/ml at initiation of dialysis and 1·1, 0·96, 1·06 and 0·68 μg/ml at 1, 2, 3 and 4 h of dialysis respectively. The thalidomide extraction coefficient was 0·057 and the dialytic clearance was 1·73 ml/min. Data regarding the pharmacokinetics of thalidomide are particularly scarce due to the absence of a suitable intravenous formulation and the withdrawal of this drug from clinical practice for several decades. To our knowledge, no pharmacokinetics data of thalidomide have been reported previously in patients with MM, either with or without renal failure. A trough plasma thalidomide level of 0·8–1·5 μg/ml is probably a suitable target in patients with MM who have renal failure. However, there is no clear correlation between the dose of thalidomide, its plasma concentration and the clinical response in patients with MM (Kumar et al, 2003). Thus, lower trough levels (around 0·5 μg/ml), as in patients 3 and 7, may be acceptable particularly in the maintenance phase of thalidomide treatment. For plasma trough levels of 0·8–1·5 μg/ml, thalidomide tolerance is fairly good in patients with renal failure. Minor thalidomide toxic effects, mainly sedation, constipation, and nausea, occur in virtually all treated patients and may subside with time. Seven of eight patients in our series experienced minor thalidomide toxicity. More serious complications such as neutropenia and thromboembolic events were not observed in our patients. However, as recently reported (Harris et al, 2003), hyperkalaemia is a specific and serious potential complication of thalidomide in patients with renal failure. It usually occurs during the first few weeks of treatment (as in patient 7) but may occur later during the treatment with thalidomide. The mechanisms underlying the thalidomide-associated hyperkalaemia remain unclear and may be related to the lysis of MM cells or an extracellular shift of potassium. In conclusion, thalidomide is, in general, a safe treatment for relapsing or refractory myeloma in patients with renal failure. However, clinicians must be aware of the risk of severe thalidomide-associated hyperkalaemia, especially in haemodialysed patients." @default.
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• W2040604017 date "2004-02-27" @default.
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• W2040604017 title "Thalidomide in patients with multiple myeloma and renal failure" @default.
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• W2040604017 doi "https://doi.org/10.1111/j.1365-2141.2004.04875.x" @default.
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