PMID- 27096106 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20160420 LR - 20201001 IS - 2162-3619 (Print) IS - 2162-3619 (Electronic) IS - 2162-3619 (Linking) VI - 5 DP - 2015 TI - A multicenter phase 2 study of pomalidomide plus dexamethasone in patients with relapsed and refractory multiple myeloma: the Japanese MM-011 trial. PG - 11 LID - 10.1186/s40164-016-0040-7 [doi] LID - 11 AB - BACKGROUND: The immunomodulatory agent pomalidomide in combination with low-dose dexamethasone has demonstrated efficacy and safety for the treatment of relapsed and refractory multiple myeloma (RRMM) in phase 2 and 3 trials. However, these trials enrolled very few Asian patients. METHODS: This phase 2 study investigated pomalidomide plus low-dose dexamethasone in 36 Japanese patients with RRMM after >/=2 prior therapies. RESULTS: Patients enrolled in the study had a relatively high disease burden (81 % Durie-Salmon stage II or III) and were heavily pretreated (median, 6.5 prior antimyeloma regimens). The overall response rate was 42 % (1 patient with complete response and 14 with partial response), with an additional 44 % (16 patients) achieving stable disease (SD). Response rates in patients aged 65 years were 47 and 35 %, respectively. None of the five patients with extramedullary disease achieved a response, with three of them maintaining SD of short duration. Median progression-free survival was 10.1 months after a 7.7-month median follow-up, and the median overall survival was not reached. The most frequent grade >/=3 adverse events (AEs) were neutropenia (64 %), anemia (42 %), and thrombocytopenia (31 %). The most frequent nonhematologic grade >/=3 AEs were pneumonia and decreased appetite (8 % each). Adverse events in patients aged >65 years were similar to those in patients aged /=3 pneumonia. CONCLUSIONS: Collectively, the results of this study demonstrate that pomalidomide plus low-dose dexamethasone is an effective and safe treatment for Japanese patients with RRMM, although careful attention needs to be paid to serious infections. TRIAL REGISTRATION: Clinicaltrials.gov NCT02011113. FAU - Ichinohe, Tatsuo AU - Ichinohe T AD - Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima 734-8553 Japan. FAU - Kuroda, Yoshiaki AU - Kuroda Y AD - Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3 Kasumi, Minami-Ku, Hiroshima 734-8553 Japan. FAU - Okamoto, Shinichiro AU - Okamoto S AD - Key University Hospital, 35 Shinanomachi, Shinjuku-Ku, Tokyo 160-8582 Japan. FAU - Matsue, Kosei AU - Matsue K AD - Kameda Medical Center, 929 Higashi-chou, Kamogawa, Chiba 296-8602 Japan. FAU - Iida, Shinsuke AU - Iida S AD - Nagoya City University Hospital, 1 Kawasumi, Mizuho-chou, Mizuho-Ku, Nagoya 467-8601 Japan. FAU - Sunami, Kazutaka AU - Sunami K AD - Okayama Medical Center, 1711-1, Tamasu, Kita-Ku, Okayama 701-1154 Japan. FAU - Komeno, Takuya AU - Komeno T AD - Mito Medical Center, 280 Sakuranosato, Ibarakimachi, Higashi-Ibaraki-Gun, Ibaraki 311-3193 Japan. FAU - Suzuki, Kenshi AU - Suzuki K AD - Japanese Red Cross Medical Center, 4-1-22 Hiroo, Shibuya-Ku, Tokyo 150-8935 Japan. FAU - Ando, Kiyoshi AU - Ando K AD - Tokai University Hospital, 143 Shimokasuya, Isehara, Kanagawa 259-1193 Japan. FAU - Taniwaki, Masafumi AU - Taniwaki M AD - University Hospital Kyoto Prefectural University of Medicine, Kawaramachi-Hirokoji, Kamigyo-Ku, Kyoto 602-8566 Japan. FAU - Tobinai, Kensei AU - Tobinai K AD - National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-Ku, Tokyo 104-0045 Japan. FAU - Chou, Takaaki AU - Chou T AD - Niigata Cancer Center Hospital, 2-15-3 Kawagishimachi, Chuo-Ku, Niigata, 951-8133 Japan. FAU - Kaneko, Hitomi AU - Kaneko H AD - Osaka Red Cross Hospital, 5-30 Fudegasaki-cho, Tennouji-Ku, Osaka 543-8555 Japan. FAU - Iwasaki, Hiromi AU - Iwasaki H AD - Kyushu University Hospital, 3-1-1 Maidashi, Higashi-Ku, Fukuoka 812-8582 Japan. FAU - Uemura, Chie AU - Uemura C AD - Celgene, 1-21-1 Toyama, Shinjuku-Ku, Tokyo 162-8655 Japan. FAU - Tamakoshi, Hiromi AU - Tamakoshi H AD - Celgene, 1-21-1 Toyama, Shinjuku-Ku, Tokyo 162-8655 Japan. FAU - Zaki, Mohamed H AU - Zaki MH AD - Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901 USA. FAU - Doerr, Thomas AU - Doerr T AD - Celgene Corporation, 86 Morris Avenue, Summit, NJ 07901 USA. FAU - Hagiwara, Shotaro AU - Hagiwara S AD - National Center for Global Health and Medicine Hospital, 15: 2-7-2 Marunouchi, Chiyoda-Ku, Tokyo 100-7010 Japan. LA - eng SI - ClinicalTrials.gov/NCT02011113 PT - Journal Article DEP - 20160418 PL - England TA - Exp Hematol Oncol JT - Experimental hematology & oncology JID - 101590676 PMC - PMC4835896 OTO - NOTNLM OT - Asian OT - Japan OT - Phase 2 OT - Plasmacytoma OT - Pomalidomide OT - Relapsed/refractory multiple myeloma EDAT- 2015/01/01 00:00 MHDA- 2015/01/01 00:01 PMCR- 2016/04/18 CRDT- 2016/04/21 06:00 PHST- 2016/02/23 00:00 [received] PHST- 2016/04/08 00:00 [accepted] PHST- 2016/04/21 06:00 [entrez] PHST- 2015/01/01 00:00 [pubmed] PHST- 2015/01/01 00:01 [medline] PHST- 2016/04/18 00:00 [pmc-release] AID - 40 [pii] AID - 10.1186/s40164-016-0040-7 [doi] PST - epublish SO - Exp Hematol Oncol. 2016 Apr 18;5:11. doi: 10.1186/s40164-016-0040-7. eCollection 2015.