Pomalidomide alone or in combination with dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma

Cancer Science

Kosei Matsue⁶  Hiromi Iwasaki⁴  Takaaki Chou²  Kensei Tobinai⁷  Kazutaka Sunami³  Yoshiaki Ogawa⁸  Mari Kurihara⁵  Shuichi Midorikawa⁵  Mohamed Zaki¹  Thomas Doerr¹ 

[1] Celgene Corporation, Summit, New Jersey, USA;Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan;Department of Hematology, National Hospital Organization, Okayama Medical Center, Okayama, Japan;Center for Cellular and Molecular Medicine, Kyushu University Hospital, Fukuoka, Japan;Celgene KK, Tokyo, Japan;Division of Hematology/Oncology, Department of Medicine, Kameda Medical Center, Kamogawa, Japan;Department of Hematology, National Cancer Center Hospital, Tokyo, Japan;Department of Hematology/Oncology, Tokai University School of Medicine, Isehara, Japan

关键词: Clinical trial;    dexamethasone;    multiple myeloma;    pharmacokinetics;    pomalidomide;   

DOI  :  10.1111/cas.12772

来源: Wiley

【 摘 要 】

Abstract

This phase 1, open-label, dose-escalation study investigated the tolerated dose (recommended dose), safety, efficacy, and pharmacokinetics of pomalidomide alone or pomalidomide plus low-dose dexamethasone in Japanese patients with refractory or relapsed and refractory multiple myeloma. Twelve patients were enrolled. Patients received pomalidomide 2 mg (Cohort 1) or 4 mg (Cohort 2) orally on day 1 and days 3–21 of a 28-day cycle. The tolerated dose of pomalidomide was determined to be 4 mg given on days 1–21 of a 28-day cycle. Efficacy outcomes with pomalidomide plus low-dose dexamethasone were consistent with those of previous studies. Responses (partial response or better) were achieved by three patients (25%; 1 [17%] in Cohort 1 and 2 [33%] in Cohort 2), and the median time to response was 6.4 months overall (9.0 months for Cohort 1 and 4.2 months for Cohort 2). The median progression-free survival was 5.5 months overall (5.1 months for Cohort 1 and not reached for Cohort 2). The most frequently occurring grade ≥3 adverse events were neutropenia (67%), anemia (25%), lymphopenia (25%), and pneumonia (25%), consistent with previous studies of pomalidomide plus low-dose dexamethasone in refractory or relapsed and refractory multiple myeloma. Further investigation of pomalidomide is recommended for Japanese patients with refractory or relapsed and refractory multiple myeloma. This study was registered with ClinicalTrials.gov (NCT01568294).

【 授权许可】

CC BY-NC-ND   
© 2015 The Authors. Cancer Science published by Wiley Publishing Asia Pty Ltd on behalf of Japanese Cancer Association.

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