TY - JOUR
T1 - Pomalidomide and dexamethasone combination with additional cyclophosphamide in relapsed/refractory multiple myeloma (AMN001)—a trial by the Asian Myeloma Network
AU - Soekojo, Cinnie Yentia
AU - Kim, Kihyun
AU - Huang, Shang Yi
AU - Chim, Chor Sang
AU - Takezako, Naoki
AU - Asaoku, Hideki
AU - Kimura, Hideo
AU - Kosugi, Hiroshi
AU - Sakamoto, Junichi
AU - Gopalakrishnan, Sathish Kumar
AU - Nagarajan, Chandramouli
AU - Wei, Yuan
AU - Moorakonda, Rajesh
AU - Lee, Shu Ling
AU - Lee, Je Jung
AU - Yoon, Sung Soo
AU - Kim, Jin Seok
AU - Min, Chang Ki
AU - Lee, Jae Hoon
AU - Durie, Brian
AU - Chng, Wee Joo
N1 - Funding Information:
Pomalidomide was provided in-kind by Celgene. This trial was supported, in part, by the Epidemiological and Clinical Research Information Network (ECRIN) in the Japanese section.
Publisher Copyright:
© 2019, The Author(s).
PY - 2019/10/1
Y1 - 2019/10/1
N2 - 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/m2 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.
AB - 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/m2 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.
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U2 - 10.1038/s41408-019-0245-1
DO - 10.1038/s41408-019-0245-1
M3 - Article
C2 - 31594919
AN - SCOPUS:85073056680
SN - 2044-5385
VL - 9
JO - Blood Cancer Journal
JF - Blood Cancer Journal
IS - 10
M1 - 83
ER -
