Pomalidomide and dexamethasone combination with additional cyclophosphamide in relapsed/refractory multiple myeloma (AMN001)-a trial by the Asian Myeloma Network

被引：14

作者：

Soekojo, Cinnie Yentia ^{[1
]}

Kim, Kihyun ^{[2
]}

Huang, Shang-Yi ^{[3
]}

Chim, Chor-Sang ^{[4
]}

Takezako, Naoki ^{[5
]}

Asaoku, Hideki ^{[6
]}

Kimura, Hideo ^{[7
]}

Kosugi, Hiroshi ^{[8
]}

Sakamoto, Junichi ^{[9
]}

Gopalakrishnan, Sathish Kumar ^{[10
]}

Nagarajan, Chandramouli ^{[10
]}

Wei, Yuan ^{[11
]}

Moorakonda, Rajesh ^{[11
]}

Lee, Shu Ling ^{[11
]}

Lee, Je Jung ^{[12
]}

Yoon, Sung-Soo ^{[13
]}

Kim, Jin Seok ^{[14
]}

Min, Chang Ki ^{[15
]}

Lee, Jae-Hoon ^{[16
]}

Durie, Brian ^{[17
]}

Chng, Wee Joo ^{[1
]}

机构：

[1] Natl Univ Canc Inst, Singapore, Singapore

[2] Sungkyunkwan Univ, Samsung Med Ctr, Seoul, South Korea

[3] Natl Taiwan Univ, Taipei, Taiwan

[4] Univ Hong Kong, Pok Fu Lam, Hong Kong, Peoples R China

[5] Natl Hosp Org Disaster Med Ctr, Tachikawa, Tokyo, Japan

[6] Hiroshima Red Cross Hosp & Atom Bomb Survivors Ho, Hiroshima, Japan

[7] Northern Fukushima Med Ctr, Fukushima, Japan

[8] Ogaki Municipal Hosp, Ogaki, Japan

[9] Tokai Cent Hosp, Kakamigahara, Japan

[10] Singapore Gen Hosp, Singapore, Singapore

[11] Singapore Clin Res Inst, Singapore, Singapore

[12] Cheonnam Univ Hwasoon Hosp, Hwasun Gun, South Korea

[13] Seoul Natl Univ Hosp, Seoul, South Korea

[14] Yonsei Univ, Coll Med, Severance Hosp, Seoul, South Korea

[15] Seoul St Marys Hosp, Seoul, South Korea

[16] Gachon Univ, Gil Med Ctr, Seongnam Si, South Korea

[17] Cedars Sinai Med Ctr, Los Angeles, CA 90048 USA

来源：

BLOOD CANCER JOURNAL | 2019年 / 9卷 / 10期

关键词：

LOW-DOSE DEXAMETHASONE; LENALIDOMIDE; THALIDOMIDE; COHORT;

D O I：

10.1038/s41408-019-0245-1

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Pomalidomide is a third generation immunomodulatory drug which in combination with dexamethasone, has been shown to be active in relapsed/refractory multiple myeloma. However, the data in Asian patients remain limited. We conducted a prospective phase two clinical trial in major cancer centers in Singapore, South Korea, Taiwan, Japan and Hong Kong to assess the efficacy and safety of pomalidomide and dexamethasone combination (PomDex)+/- cyclophosphamide in Asian patients with relapsed/refractory multiple myeloma who failed lenalidomide and bortezomib. Patients were treated with pomalidomide (4 mg daily for 21 days every 4 weeks) and dexamethasone (40 mg weekly). If there is less than a minimal response after three cycles of PomDex, cyclophosphamide 300 mg/m(2) can be added (PomCyDex). A total of 136 patients were enrolled. The median PFS was 9 and 10.8 months for the PomDex and PomCyDex group, respectively. The median OS was 16.3 months. This regimen appears to be active across age groups and prior lines of treatment. This combination was overall well tolerated with grade 3 and 4 adverse events of mainly cytopenias. PomDex is highly active and well-tolerated in Asian patients. The addition of cyclophosphamide can improve the response and outcomes further in patients with suboptimal response to PomDex.

引用

页数：10

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