Phase I study of once weekly treatment with bortezomib in combination with lenalidomide and dexamethasone for relapsed or refractory multiple myeloma

被引:6
作者
Totani, Haruhito [1 ]
Ri, Masaki [1 ]
Kato, Chie [1 ]
Nakashima, Takahiro [1 ]
Suzuki, Nana [1 ]
Hagiwara, Shinya [1 ]
Kanamori, Takashi [1 ]
Murakami, Satsuki [1 ]
Masuda, Arisa [1 ]
Kinoshita, Shiori [1 ]
Yoshida, Takashi [1 ]
Narita, Tomoko [1 ]
Ito, Asahi [1 ]
Kusumoto, Shigeru [1 ]
Ishida, Takashi [1 ]
Komatsu, Hirokazu [1 ]
Iida, Shinsuke [1 ]
机构
[1] Nagoya City Univ, Grad Sch Med Sci, Dept Hematol & Oncol, Mizuho Ku, 1 Kawasumi, Nagoya, Aichi 4678601, Japan
关键词
Multiple myeloma; Bortezomib; Lenalidomide; Refractory; BLd; PLUS DEXAMETHASONE; DRUG-RESISTANCE; CELLS; THALIDOMIDE; THERAPY; TRIAL; ANALOGS;
D O I
10.1007/s12185-015-1925-7
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Proteasome inhibitors (PIs) in combination with immunomodulatory drugs (IMiDs) have been shown to be effective against relapsed/refractory multiple myeloma (RRMM). To determine the optimal dosing schedule of once weekly bortezomib (BTZ) combined with lenalidomide (LEN) and dexamethasone (DEX), especially in the outpatient setting, we conducted a phase I dose escalation study. A 21-day cycle of BTZ 1.3 mg/m(2) on days 1 and 8, LEN 10 mg/day (cohort 1) or 15 mg/day (cohort 2) on days 1-14, and DEX 20 mg/day on days 1, 2, 8, and 9 was administered. Three patients were enrolled in each cohort. No dose-limiting toxicity was observed in either cohort. Although hematological toxicities estimated as > grade 3 were common, non-hematological toxicities of grade 3 or higher were rare. Two cases of newly diagnosed peripheral neuropathy (PN) were observed, while no grade 3/4 PN was observed. Two patients achieved partial response and two achieved stable disease. The recommended doses of BTZ and LEN were determined to be 1.3 mg/m(2) and 15 mg, respectively. Combination therapy of once weekly BTZ with LEN and DEX was well tolerated and shows promise as a regimen for patients with RRMM previously treated with both PIs and IMiDs.
引用
收藏
页码:316 / 321
页数:6
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