<Originals> Efficacy and safety of Clarithromycin, Lenalidomide and Dexamethasone (BiRd) therapy for Japanese relapsed or refractory multiple myeloma

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[Abstract] Object: It is difficult for the elderly, those with complications, and those who live in remote areas to visit the hospital, and as a result there are limits on the drugs they are able to use. It is therefore effective to prescribe such patients oral medications that have few adverse effects and in regimens that require few hospital visits. Clarithromycin can induce cell death by autophagy and it has a direct antitumor effect. There have been reports of the outcomes of Lenalidomide (Len) and Dexamethasone (Dex) therapy with clarithromycin (CAM) (BiRd therapy) which is administered orally and is safe on multiple myeloma (MM). However, in Japan there have been few studies. Here, we report the efficacy and safety of BiRd therapy for elderly patients with MM in our hospital. Method: We analyzed 7 patients with relapsed refractory or refractory multiple myeloma who were treated at our hospital between January 2012 and December 2014. The BiRd therapy was administered in a 28-day cycle as follows: CAM 400 mg/day for 28 days, Len 15 mg/day for 21 days, and Dex was administered in a dose of 20 mg once per week. The response criteria used were standard International Myeloma Working Group (IM-WG) Uniform Response Criteria. and adverse events were graded according to the NCI-CTCAE Ver. 4. Statistical analysis was performed using EZR. Result: The response to BiRd therapy was stringent Complete response (sCR) in 2 patients, Complete response (CR) in 1 patient, very good partial response (PR) in 3 patients, and stable disease (SD) in 1 patient. Response rates of PR or better were observed in 86% of the patients. Duration of response was median 316 days (range, 160-522 days). Median OS period was 1,907 days. Median OS following discontinuation of the study was 1,385 days. Hematological adverse events were G1-2 anemia in 3 patients and G3-4 anemia in 1 patient. G1-2 thrombocytopenia was observed in 1 patient and G3-4 thrombocytopenia was observed in 1 patient. Leukopenia of G1-2 was observed in 6 patients but G3 was not observed. Non-hematological adverse events were G1-2 liver disorder in 6 patients, G1-2 skin rash in 3 patients,and G1-2 constipation in 2 patients. G4 adverse events were fainting and duodenal ulcer in 1 patient each. Conclusion: BiRd therapy can be safely and effectively administered in the elderly patients with MM.

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