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Treatment of Patients with Multiple Myeloma with Ibandronate and Correlation with Type I Collagen Degradation Product

Treatment of Patients with Multiple Myeloma with Ibandronate and Correlation with Type I Collagen Degradation Product

Blood 100(11): Abstract No 1547, November 16

The bisphosphonate ibandronate (IB) is found to reduce, significantly, the occurrence of osteolytic bone lesions in a murine model of myeloma bone disease. The carboxy-terminal telopeptide of type I collagen (ICTP) is a serum marker of bone metastasis in patients (pts) with solid tumors and can be used as a serum marker of bone metabolism in multiple myeloma (MM). The aim of the current study is to investigate the efficacy and safety of IB treatment in MM pts with osteolytic lesions and also evaluate serum ICTP levels post IB treatment. Sixteen MM pts with osteolytic lesions, 6 M and 10 F, with a median age of 72 years (range 47-86 ) were treated with IB at a dose of 4 mg, administered by IV infusion over 1h, every 4 weeks for at least 12 months. IB was administered approximately one week after the end of the patient's chemotherapy. None of the pts had renal or hepatic dysfunction or metabolic bone disease. Pts were clinically evaluated before, during and after IB administration for possible occurrence of side effects. Routine serum chemical screening including beta-2 microglobulin (beta2-m), calcium and alkaline phosphate and radiographic evaluation of osteolytic lesions were performed during the study. Serum samples were taken before each IB administration and stored frozen until used for measurement of ICTP levels with b-CrossLaps/serum immunoassay. Clinical improvement of skeletal pains was observed after the first cycle of IB treatment with total pain relief during the third month. Radiographic evaluation after six months of treatment showed partial remission of osteolytic bone lesions. There were no major side effects after IB administration except for mild vomiting in two pts. Haematologic, hepatic or renal dysfunction were not detected except for transient hypocalcaemia and hypophosphataemia in 5 pts (31%). High mean serum ICTP levels were documented only in 3/16 pts ( 1,513 +-0,31 ng/ml ) while the remainder of pts had levels within normal limits ( 0,392 +- 0,31 ng/ml). High serum ICTP levels were correlated with progressive osteolytic bone disease and elevated serum levels of beta2-m, hypercalcaemia, bad performance status and stage of disease. Treatment with IB, in these fore mentioned 3 pts, resulted in reducing the high ICTP levels in normal limits even after the first cycle of treatment ( pre: 1,513 +-0,31 ng/ml, post: 0,881 +- 0,38 ng/ml ). If the decrease of serum ICTP levels caused by IB treatment is confirmed, in future trials, with a greater number of pts, serum ICTP levels can be used as a prognostic index in MM. Treatment of MM pts with osteolytic lesions with IOTABETA is well tolerated and probably may decrease serum ICTP levels.

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Accession: 035980568

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