PMID- 27738809 OWN - NLM STAT- MEDLINE DCOM- 20170526 LR - 20181203 IS - 1432-0843 (Electronic) IS - 0344-5704 (Print) IS - 0344-5704 (Linking) VI - 78 IP - 5 DP - 2016 Nov TI - A phase II trial of small-dose bortezomib, lenalidomide and dexamethasone (sVRD) as consolidation/maintenance therapy in patients with multiple myeloma. PG - 1041-1049 AB - PURPOSE: Consolidation/maintenance therapy induces deep remission in patients with multiple myeloma (MM); however, the most suitable regimen has been under investigation. The combination therapy with bortezomib, lenalidomide and dexamethasone (VRD) is a powerful regimen for relapsed/refractory as well as newly diagnosed MM as an induction therapy. However, severe adverse events (AEs) may become a problem when VRD is introduced without dose reduction as a consolidation/maintenance therapy. METHODS: In this single-arm phase II study, we evaluated the efficacy of small-dose VRD regimen (sVRD) in the consolidation/maintenance setting. Sixteen patients who had partial response (PR) or better after any induction therapy were enrolled. Patients received at least six 28-day cycles of subcutaneous bortezomib (1.3 mg/m(2) on days 1 and 15), lenalidomide (10 mg on days 1-21) and dexamethasone (40 mg on days 1, 8, 15 and 22). RESULTS: The overall response rate and the complete response (CR) rate were 100 and 43.8 %, respectively. In particular, one patient with CR and two patients with very good PR at enrollment achieved stringent CR during 6 courses of sVRD. With a median follow-up time of 29.4 months, the median progression-free survival (PFS) and overall survival (OS) were not reached, while the PFS and OS rates at 2.5 years were 66.6 and 77.3 %, respectively. Univariate analysis demonstrated that disease progression as a reason for discontinuation of sVRD had a negative impact on OS. There were no grade 3 or 4 hematologic or nonhematologic AEs. CONCLUSION: Our sVRD regimen as a consolidation/maintenance therapy was highly effective and well tolerable. FAU - Ibata, Soushi AU - Ibata S AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Sato, Tsutomu AU - Sato T AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. tsutomus@sapmed.ac.jp. FAU - Kuroda, Hiroyuki AU - Kuroda H AD - Gastroenterology and Hematology/Clinical Oncology, Internal Medicine, Steel Memorial Muroran Hospital, Muroran, Japan. FAU - Nagamachi, Yasuhiro AU - Nagamachi Y AD - Department of Hematology, Kiyota Hospital, Sapporo, Japan. FAU - Iyama, Satoshi AU - Iyama S AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Fujimi, Akihito AU - Fujimi A AD - Department of Hematology and Oncology, Oji General Hospital, Tomakomai, Japan. FAU - Kamihara, Yusuke AU - Kamihara Y AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Konuma, Yuichi AU - Konuma Y AD - Department of Hematology and Oncology, Asahikawa Red Cross Hospital, Asahikawa, Japan. FAU - Yoshida, Masahiro AU - Yoshida M AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Tatekoshi, Ayumi AU - Tatekoshi A AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Hashimoto, Akari AU - Hashimoto A AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Horiguchi, Hiroto AU - Horiguchi H AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Ono, Kaoru AU - Ono K AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Murase, Kazuyuki AU - Murase K AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Takada, Kohichi AU - Takada K AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Miyanishi, Koji AU - Miyanishi K AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Kobune, Masayoshi AU - Kobune M AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. FAU - Hirayama, Yasuo AU - Hirayama Y AD - Division of Internal Medicine, Higashi Sapporo Hospital, Sapporo, Japan. FAU - Kato, Junji AU - Kato J AD - Department of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20161013 PL - Germany TA - Cancer Chemother Pharmacol JT - Cancer chemotherapy and pharmacology JID - 7806519 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Antineoplastic Agents) RN - 0 (Antineoplastic Agents, Hormonal) RN - 4Z8R6ORS6L (Thalidomide) RN - 69G8BD63PP (Bortezomib) RN - 7S5I7G3JQL (Dexamethasone) RN - F0P408N6V4 (Lenalidomide) SB - IM MH - Aged MH - Angiogenesis Inhibitors/administration & dosage MH - Antineoplastic Agents/administration & dosage MH - Antineoplastic Agents, Hormonal/administration & dosage MH - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse effects/*therapeutic use MH - Bortezomib/administration & dosage MH - Dexamethasone/administration & dosage MH - Disease-Free Survival MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Lenalidomide MH - Male MH - Middle Aged MH - Multiple Myeloma/*drug therapy/secondary MH - Neoplasms, Second Primary/epidemiology MH - Thalidomide/administration & dosage/analogs & derivatives MH - Treatment Outcome PMC - PMC5083756 OTO - NOTNLM OT - Bortezomib OT - Consolidation/maintenance OT - Dexamethasone OT - Lenalidomide OT - Multiple myeloma OT - VRD COIS- All authors declare no conflicts of interest. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. EDAT- 2016/10/28 06:00 MHDA- 2017/05/27 06:00 PMCR- 2016/10/13 CRDT- 2016/10/15 06:00 PHST- 2016/01/26 00:00 [received] PHST- 2016/10/06 00:00 [accepted] PHST- 2016/10/28 06:00 [pubmed] PHST- 2017/05/27 06:00 [medline] PHST- 2016/10/15 06:00 [entrez] PHST- 2016/10/13 00:00 [pmc-release] AID - 10.1007/s00280-016-3163-y [pii] AID - 3163 [pii] AID - 10.1007/s00280-016-3163-y [doi] PST - ppublish SO - Cancer Chemother Pharmacol. 2016 Nov;78(5):1041-1049. doi: 10.1007/s00280-016-3163-y. Epub 2016 Oct 13.