期刊
BRITISH JOURNAL OF HAEMATOLOGY
卷 162, 期 2, 页码 202-209出版社
WILEY
DOI: 10.1111/bjh.12361
关键词
relapsed/refractory multiple myeloma; lenalidomide; bendamustine; prednisolone; phase 1 study
类别
资金
- Celgene
- Mundipharma
- Amgen
This phase 1 dose finding study tested a combination of lenalidomide, bendamustine and prednisolone (RBP) in 21 patients in five cohorts with advanced multiple relasped/refractory myeloma (MM) to determine the maximum tolerable dose (MTD) of the combination. The first cohort received a starting dose of lenalidomide 10mg/d, days 1-21, bendamustine 60mg/m(2)/d, days 1-2, and prednisolone 100mg/d, days 1-4. Dose escalation was done in cohorts of three to six patients with lenalidomide dose increasing to 15, 20 and 25mg, and after reaching 25mg/d, bendamustine was increased to 75mg/m(2). A total of 21 patients were enrolled and all completed at least two cycles. Two patients developed dose-limiting haemotoxicity: one patient on lenalidomide 25mg/d and bendamustine 60mg/m(2) and another patient at the highest dose level (lenalidomide 25mg/d and bendamustine 75mg/m(2)). The MTD was not reached. Sixteen patients (76%) responded after at least two cycles of RBP with one stringent complete response (CR), one near CR, five very good partial response and nine partial response. After a median observation time of 16months, progression-free survival at 18months was 48% and overall survival was 64%. In conclusion, RBP with lenalidomide 25mg/d, days 1-21 and bendamustine 75mg/m(2) days 1-2 is well tolerated in patients with relapsed/refractory MM.
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