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Bortezomib Etc Multiples Myelo bortezomib AND cyclophosphamide AND dexamethasone AND multi... https://www.ncbi.nlm.nih.gov/pubmed Back to top 11 von 11 16.04.2019, 14:13 4/18/2019 Advanced Search | Cochrane Library https://www.cochranel brary.com/de/advanced-search 2/2 SEARCH QUERY ('bortezomib'/exp OR bortezomib) AND ('cyclophosphamide'/exp OR cyclophosphamide) AND ('dexamethasone'/exp OR dexamethasone) AND ('multiple myeloma'/exp OR 'multiple myeloma') AND 'newly diagnosed' AND 'clinical trial' AND 'induction therapy' RECORD 1 Nicht betrachtet, da bereits in Pubmed-Recherche enthalten Efficacy and Safety of a Weekly Cyclophosphamide-Bortezomib-Dexamethasone Regimen as Induction Therapy Prior to Autologous Stem Cell Transplantation in Japanese Patients with Newly Diagnosed Multiple Myeloma: A Phase 2 Multicenter Trial Tanaka K., Toyota S., Akiyama M., Wakimoto N., Nakamura Y., Najima Y., Doki N., Kakihana K., Igarashi A., Kobayashi T., Ohashi K., Kudo D., Shinagawa A., Takano H., Fujio T., Okoshi Y., Hori M., Kumagai T., Saito T., Mukae J., Yamamoto K., Tsutsumi I., Komeno T., Yoshida C., Yamamoto M., Kojima H. Acta Haematologica (2019) 141:2 (111-118). Date of Publication: 1 Feb 2019 We assessed the efficacy and safety of weekly cyclophosphamide-bortezomib­ dexamethasone (CBD) induction prior to autologous stem cell transplantation (ASCT) in newly diagnosed Japanese patients with multiple myeloma (MM). This regimen consisted of four 28-day cycles of once-weekly oral cyclophosphamide (300 mg/m(2)), subcutaneous bortezomib (1.3 mg/m(2)), and oral dexamethasone (40 mg). Responding patients underwent stem cell collection followed by ASCT. The primary endpoint was the postinduction rate of achieving a near complete response (nCR) or better. Among the 38 enrolled patients, a complete response (CR), an nCR, a very good partial response (VGPR), and a partial response (PR) were achieved in 10.5, 2.6, 23.7, and 36.8% of cases, respectively. A grade 4 hematological adverse event (AE) was observed in 1 patient. Grade 3-4 infection, including febrile neutropenia, was observed in 4 patients (10.5%). Although 2 patients dropped out due to AE, 94.7% of the patients completed the induction phase. However, because of a poor response to induction chemotherapy (<PR in 6 patients), poor stem cell mobilization (4 patients), and a protocol violation (1 patient), only 24 patients (63.2%) proceeded to ASCT. The 2-year progression-free and overall survivals were 55.3 and 82.7%, respectively. We thus believe that the therapeutic power of weekly CBD is not strong enough as a 3-drug induction regimen despite its feasibility for most Japanese patients. OPEN URL LINK http://resolver.ebscohost.com/openurlAll/?sid=EMBASE&sid=EMBASE&issn=14219662 &id=doi:10.1159%2F000495338&atitle=Efficacy+and+Safety+of+a+Weekly+Cyclophos 86 Records downloaded - Fri 4 26 09:28:10 UTC 2019 Page 1 Dexamethasone+Regimen+as+Induction+Therapy+Prior+to+Autologous+Stem+Cell+Tr ansplantation+in+Japanese+Patients+with+Newly+Diagnosed+Multiple+Myeloma%3A+ A+Phase+2+Multicenter+Trial&stitle=Acta+Haematol.&title=Acta+Haematologica&volu me=141&issue=2&spage=111&epage=118&aulast=Tanaka&aufirst=Keisuke&auinit=K. &aufull=Tanaka+K.&coden=ACHAA&isbn=&pages=111­ 118&date=2019&auinit1=K&auinitm= RECORD 2 Nicht betrachtet, da bereits in Pubmed-Recherche enthalten A phase II study of lenalidomide consolidation and maintenance therapy after autologous PBSCT in patients with multiple myeloma Fuchida S.-I., Sunami K., Matsumoto M., Okumura H., Murayama T., Miyamoto T., Otsuka E., Fujishima N., Izumi T., Tamaki S., Hiramatsu Y., Kuroda Y., Shimazaki C., Akashi K., Harada M. International Journal of Hematology (2019) 109:1 (107-114). Date of Publication: 22 Jan 2019 The efficacy and safety of lenalidomide (LEN) consolidation therapy and subsequent LEN maintenance therapy after high-dose therapy with autologous peripheral blood stem cell transplantation (auto-PBSCT) were evaluated in patients with newly diagnosed symptomatic multiple myeloma (MM). Forty-one patients were enrolled and received high-dose dexamethasone (DEX) therapy as an initial induction. The patients who did not respond to the DEX therapy were further treated with four cycles of bortezomib plus DEX (BD) induction therapy. For patients who responded to BD, PBSC harvesting was scheduled following high-dose cyclophosphamide and filgrastim administration. After PBSC harvesting, high-dose chemotherapy of melphalan with auto-PBSCT was performed. One hundred days after auto-PBSCT, patients received consolidation therapy consisting two cycles of LEN plus low-dose DEX (Ld) and LEN maintenance therapy. Only one death occurred during mobilization therapy, but the protocol developed in this study was considered generally safe to provide. Overall response rates after consolidation and maintenance therapies were 73.7% and 81.6%, respectively. Two-year progression-free survival and overall survival were 76.3% and 92.1%, respectively. These observations suggest that LEN consolidation and maintenance therapy are effective and safe, and provide favorable response rates in patients with MM. OPEN URL LINK http://resolver.ebscohost.com/openurlAll/?sid=EMBASE&sid=EMBASE&issn=18653774 &id=doi:10.1007%2Fs12185-018-2543­ y&atitle=A+phase+II+study+of+lenalidomide+consolidation+and+maintenance+therapy +after+autologous+PBSCT+in+patients+with+multiple+myeloma&stitle=Int.+J.+Hematol .&title=International+Journal+of+Hematology&volume=109&issue=1&spage=107&epag 86 Records downloaded - Fri 4 26 09:28:10 UTC 2019 Page 2 Efficacy and safety of once-weekly cyclophosphamide-bortezomib­ dexamethasone (cbd) regimen as induction therapy prior to autologous stem cell transplantation in japanese patients with newly diagnosed multiple myeloma.-A phase 2 multicenter trial Kudo D., Komeno T., Yoshida C., Tsutsumi I.O., Ohashi K., Kakihana K., Kobayashi T., Doki N., Najima Y., Igarashi A., Hori M., Okoshi Y., Fujio T., Shinagawa A., Yamamoto M., Takano H., Kumagai T., Yamamoto K., Toyota S., Nakamura Y., Kojima H. Blood (2018) 132 Suppl. 1. Date of Publication: 1 Nov 2018 Introduction: Although a previous study with small numbers of patients (Pts) reported comparable efficacy and less toxicity of once-weekly CBD as an induction compared to twice-weekly CBD for newly diagnosed MM (NDMM) Pts (Blood 2010; 11 5:341 6-341 7), it has never been verified thereafter. Methods: This multicenter, single-arm, open­ label, phase 2 study was conducted at 1 3 institutions in Japan. Pts aged 1 5-65 years with NDMM were eligible. Additional inclusion criteria were ECOG PS 0-2 and adequate organ functions. Pts with ≥G2 peripheral neuropathy (PN) were excluded. Pts were enrolled between January 201 3 and November 201 5. Induction chemotherapy consisted of four 28-day cycles of cyclophosphamide (CPA: 300 mg/m(2), PO), bortezomib (1.3 mg/m(2), SC), and dexamethasone (40 mg/body, PO) each administered on day 1, 8, 15, and 22. Stem cells were mobilized by administering CPA plus G-CSF. High-dose therapy (HDT) prior to ASCt was performed using melphalan (200 mg/m(2)). The primary endpoint was the post-induction ≥nCR rate. Observation was stopped on August 31, 2016. Results: A total of 38 Pts with median age of 61 (47­ 65 years old) were enrolled. ISS stages were I, II, and III in 1 0, 18, and 1 0 patients, respectively. Among the 34 chromosomal data-available Pts, del 1 3 and hypoploidy were observed in 2 and 1, respectively. During the induction, only one patient developed G4 hematological AE. G3 infectious AE was observed in 4 Pts (10.5%). Three Pts (7.9%) developed G4 non-hematological AE. PN was observed in 2 Pts (all <G3). No Pts died during the induction phase. Totally, 2Pts dropped out during the induction due to non-hematological AE, and 6 Pts dropped out after the induction due to insufficient efficacy. Post-induction ORR was 73.7%, including 10.5% CR, 2.6% nCR, and 23.7% VGPR by ITt analysis. Although 30 Pts proceeded to stem cell mobilization, 6Pts dropped out (harvest failure; 4, protocol violation; 1, physician's decision; 1). Accordingly, HDT/ASCT was performed in 24 Pts (63.2%). The post-HDT/ASCT ORR was 63.2%, including 10.5% CR, 10.5% nCR, and 10.5% VGPR by ITt analysis. In the 24 Pts who completed HDT/ASCT, ≥nCR and >VGPR rates improved from 16.7% to 33.3% and from 41.7% to 50.0%, respectively (Fig.1). The median follow-up duration was 578.5 days. PFS at 1, 2, and 3 years was 78.0%, 55.3% and 48.4%, respectively, with a median PFS of 816 days. OS at 1 and 2 years was 97.3% and 82.7%, respectively (Fig.2). The median OS was not reached. The therapeutic efficacy and 86 Records downloaded - Fri 4 26 09:28:10 UTC 2019 Page 4 feasibility of the present study were compared with those in our previous study with the VAD/BD induction regimen, which contained one cycle of VAD followed by 3 cycles of twice-weekly BD (Int J Myeloma 201 5; 5:1 5-22). Although the percentage of Pts discontinuing the induction chemotherapy due to AE was lower for the CBD regimen (5.3% vs 19.5%, p=0.0894), discontinuation due to poor response showed the tendency to be more frequent (1 5.8% vs 4.9%, p=0.145). There was no significant difference in PFS or OS between these 2 studies. Conclusion: Although once-weekly CBD is a well­ tolerated standard induction chemotherapy prior to ASCt for most Japanese patients, its therapeutic power may be too low to achieve a deep response. OPEN URL LINK http://resolver.ebscohost.com/openurlAll/?sid=EMBASE&sid=EMBASE&issn=00064971 &id=doi:10.1182%2Fblood-2018-99-113788&atitle=Efficacy+and+safety+of+once­ weekly+cyclophosphamide-bortezomib­
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