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Article: [Multiple myeloma: a focus on drugs under development].

Sunami, Kazutaka

Rinsho ketsueki] The Japanese journal of clinical hematology

2020 Volume 61, Issue 5, Page(s) 520–527

Abstract: The introduction of proteasome inhibitors and immunomodulatory and antibody drugs has dramatically improved the prognosis of multiple myeloma (MM) in the 21st century. Despite the development of such highly effective MM therapeutics, however, patients ... ...

Abstract	The introduction of proteasome inhibitors and immunomodulatory and antibody drugs has dramatically improved the prognosis of multiple myeloma (MM) in the 21st century. Despite the development of such highly effective MM therapeutics, however, patients may develop drug resistance and become refractory to standard therapies, and thus cannot be cured. New molecular targeted (venetoclax, selinexor), immunomodulatory (iberdomide), and antibody drugs (isatuximab, belantamab mafodotin), as well as bispecific T-cell engagers (BiTE) and chimeric antigen receptor T-cell (CAR T-cell) therapy, have been developed in the past 1-2 years, and promising results have been reported. In this article, we mainly review these drugs currently under development.
MeSH term(s)	Humans ; Immunotherapy ; Multiple Myeloma/drug therapy ; Proteasome Inhibitors ; T-Lymphocytes
Chemical Substances	Proteasome Inhibitors
Language	Japanese
Publishing date	2020-05-28
Publishing country	Japan
Document type	Journal Article
ZDB-ID	390900-1
ISSN	0485-1439
ISSN	0485-1439
DOI	10.11406/rinketsu.61.520
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Article: Treatment strategy in untreated transplant-eligible multiple myeloma patients.

Sunami, Kazutaka

Rinsho ketsueki] The Japanese journal of clinical hematology

2016 Volume 57, Issue 10, Page(s) 2064–2073

Abstract: Autologous stem cell transplantation (ASCT) is known to be superior to conventional chemotherapies and has been established as a standard of care for young patients with multiple myeloma. In the first decade of this century, novel agents such as ... ...

Abstract	Autologous stem cell transplantation (ASCT) is known to be superior to conventional chemotherapies and has been established as a standard of care for young patients with multiple myeloma. In the first decade of this century, novel agents such as thalidomide, bortezomib, and lenalidomide became clinically available, and several clinical trials using these drugs as induction therapies, conditioning regimens, and post-transplant consolidation and maintenance therapies have been reported, leading to increasing improvement in treatment results as compared to conventional therapies. Future changes in therapeutic strategies using these novel agents are anticipated to increase the complete response rate and prolong progression free survival and overall survival. This article describes the optimal treatment strategy for ASCT-eligible patients in Japan.
MeSH term(s)	Humans ; Multiple Myeloma/diagnosis ; Multiple Myeloma/therapy ; Patient Selection ; Stem Cell Transplantation ; Transplantation Conditioning ; Transplantation, Autologous
Language	Japanese
Publishing date	2016
Publishing country	Japan
Document type	Journal Article ; Review
ZDB-ID	390900-1
ISSN	0485-1439
ISSN	0485-1439
DOI	10.11406/rinketsu.57.2064
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Article: [Efficacy of novel agents for patients with newly diagnosed symptomatic multiple myeloma].

Sunami, Kazutaka

Rinsho ketsueki] The Japanese journal of clinical hematology

2012 Volume 53, Issue 6, Page(s) 580–586

MeSH term(s)	Antineoplastic Agents/therapeutic use ; Clinical Trials as Topic ; Humans ; Multiple Myeloma/diagnosis ; Multiple Myeloma/drug therapy ; Multiple Myeloma/surgery ; Stem Cell Transplantation ; Survival Analysis ; Transplantation, Autologous
Chemical Substances	Antineoplastic Agents
Language	Japanese
Publishing date	2012-06
Publishing country	Japan
Document type	Journal Article
ZDB-ID	390900-1
ISSN	0485-1439
ISSN	0485-1439
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Article ; Online: Autologous HSCT with novel agent-based induction and consolidation followed by lenalidomide maintenance for untreated multiple myeloma.

Mori, Yasuo / Takizawa, Jun / Katsuoka, Yuna / Takezako, Naoki / Nagafuji, Koji / Handa, Hiroshi / Kuroda, Junya / Sunami, Kazutaka / Kamimura, Tomohiko / Ogawa, Ryosuke / Kikushige, Yoshikane / Harada, Mine / Akashi, Koichi / Miyamoto, Toshihiro

Cancer science

2024

Abstract: Triplet regimen comprising proteasome inhibitors, immunomodulatory drugs, and dexamethasone (DEX) is a recommended induction/consolidation therapy for multiple myeloma (MM) patients eligible for transplant. In this Japanese phase II study conducted from ... ...

Abstract	Triplet regimen comprising proteasome inhibitors, immunomodulatory drugs, and dexamethasone (DEX) is a recommended induction/consolidation therapy for multiple myeloma (MM) patients eligible for transplant. In this Japanese phase II study conducted from 2017 to 2019, newly diagnosed MM patients aged 20-65 received four induction cycles with bortezomib (Bor), lenalidomide (Len), and DEX (VRD), followed by Bor and high-dose melphalan with autologous stem cell rescue. Subsequently, they underwent four consolidation cycles with carfilzomib, Len, and DEX (KRD), followed by Len maintenance until disease progression. A total of 141 patients were analyzed. In an intent-to-treat population, the complete or better response post induction was 19.9%, rising to 39.7%, 58.9%, and 62.4% after transplant, consolidation, and 1-year maintenance, respectively. With a median follow-up of 38 months, the 3-year progression-free survival (PFS) rate was 83.5% and the 3-year overall survival rate was 92.5%. Severe adverse events (≥grade 3) occurred in ~30% of patients; however, there was no treatment-related mortality. These findings clearly showed the tolerability and effectiveness of this protocol. Nevertheless, patients with high-risk cytogenetics showed a trend toward lower 3-year PFS than those without (77.8% vs. 89.4%, p = 0.051), and ultra-high-risk cytogenetics (≥2 high-risk cytogenetics) had an even worse prognosis, with 61.2% 3-year PFS. To overcome this situation, a more potent treatment strategy incorporating novel agents such as the CD38-antibody should be assessed in future studies.
Language	English
Publishing date	2024-03-18
Publishing country	England
Document type	Journal Article
ZDB-ID	2115647-5
ISSN	1349-7006 ; 1349-7006
ISSN (online)	1349-7006
ISSN	1349-7006
DOI	10.1111/cas.16158
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Article: Bendamustine Plus Rituximab as Salvage Treatment for Patients with Relapsed or Refractory Low-grade B-cell Lymphoma and Mantle Cell Lymphoma: A Single-Center Retrospective Study.

Murakami, Hiroyuki / Yoshioka, Takanori / Moriyama, Takashi / Ishikawa, Tatsunori / Makita, Masanori / Sunami, Kazutaka

Acta medica Okayama

2021 Volume 75, Issue 4, Page(s) 461–469

Abstract: Bendamustine plus rituximab (B-R) is an effective therapy for relapsed or refractory (r/r) low-grade B-cell lymphoma (LGBCL) and mantle cell lymphoma (MCL); however, clinical data from Japanese patients treated with B-R therapy are limited. We ... ...

Abstract	Bendamustine plus rituximab (B-R) is an effective therapy for relapsed or refractory (r/r) low-grade B-cell lymphoma (LGBCL) and mantle cell lymphoma (MCL); however, clinical data from Japanese patients treated with B-R therapy are limited. We retrospectively evaluated the efficacy and safety of B-R therapy in 42 patients who received B-R therapy at our hospital for r/r LGBCL and MCL. All patients received intravenous (IV) ritux-imab 375 mg/m2 on day 1 and IV bendamustine 90 mg/m2 on days 2 and 3 every 28 days for up to 6 cycles. The common histologic subtypes were follicular lymphoma (n = 29, 70%), marginal zone lymphoma (n = 6, 14%), and MCL (n = 5, 12%). The overall response rate was 93%, with 62% complete response and complete response unconfirmed. The median progression-free survival (PFS) was 38 months (95% confidence interval [CI], 24.6 to not reached [NR]), and the median overall survival (OS) was 80 months (95% CI, 60.7 to NR). Patients receiving a cumulative dose of bendamustine ≥ 720 mg/m2 showed a significantly longer PFS and OS. Grade 3/4 adverse events (≥ 10%) included neutropenia (55%), lymphopenia (69%), and nausea (24%). B-R therapy was effective and well tolerated, and the cumulative dose of bendamustine was associated with a favorable outcome.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents, Alkylating/administration & dosage ; Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/administration & dosage ; Bendamustine Hydrochloride ; Disease-Free Survival ; Female ; Humans ; Japan ; Lymphoma, B-Cell/drug therapy ; Lymphoma, Mantle-Cell/drug therapy ; Male ; Middle Aged ; Neoplasm Recurrence, Local/drug therapy ; Progression-Free Survival ; Retrospective Studies ; Rituximab ; Salvage Therapy/methods
Chemical Substances	Antineoplastic Agents, Alkylating ; Antineoplastic Agents, Immunological ; Rituximab (4F4X42SYQ6) ; Bendamustine Hydrochloride (981Y8SX18M)
Language	English
Publishing date	2021-09-12
Publishing country	Japan
Document type	Journal Article
ZDB-ID	188415-3
ISSN	0386-300X ; 0001-6152
ISSN	0386-300X ; 0001-6152
DOI	10.18926/AMO/62398
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Article ; Online: Angioimmunoblastic T-cell Lymphoma Presenting as a Methotrexate-associated Lymphoproliferative Disorder with Extreme Peripheral Blood Plasmacytosis.

Murakami, Hiroyuki / Makita, Masanori / Ishikawa, Tatsunori / Yoshioka, Takanori / Nagakita, Keina / Shinno, Yoko / Yoshino, Tadashi / Maeda, Yoshinobu / Sunami, Kazutaka

Internal medicine (Tokyo, Japan)

2022 Volume 61, Issue 17, Page(s) 2655–2660

Abstract: A 74-year-old man was admitted to our hospital because of systemic lymphadenopathy, weight loss, and a fever at night that had persisted for approximately 1 month. Blood tests revealed extreme peripheral blood plasmacytosis and hypergammaglobulinemia. A ... ...

Abstract	A 74-year-old man was admitted to our hospital because of systemic lymphadenopathy, weight loss, and a fever at night that had persisted for approximately 1 month. Blood tests revealed extreme peripheral blood plasmacytosis and hypergammaglobulinemia. A lymph node biopsy showed angioimmunoblastic T-cell lymphoma (AITL). Based on the history of methotrexate (MTX) administration, the established diagnosis was MTX-associated lymphoproliferative disorder (MTX-LPD). After MTX was discontinued, the lymphadenopathy spontaneously regressed and the plasmacytosis disappeared. He had no disease progression for three years. We found that AITL as an MTX-LPD can cause plasmacytosis, and the prognosis of this disease may not be poor.
MeSH term(s)	Aged ; Humans ; Immunoblastic Lymphadenopathy/chemically induced ; Immunoblastic Lymphadenopathy/diagnosis ; Lymphadenopathy/chemically induced ; Lymphadenopathy/complications ; Lymphoma, T-Cell/chemically induced ; Lymphoma, T-Cell/drug therapy ; Lymphoproliferative Disorders/chemically induced ; Lymphoproliferative Disorders/complications ; Lymphoproliferative Disorders/diagnosis ; Male ; Methotrexate/adverse effects
Chemical Substances	Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2022-02-08
Publishing country	Japan
Document type	Case Reports ; Journal Article
ZDB-ID	32371-8
ISSN	1349-7235 ; 0021-5120 ; 0918-2918
ISSN (online)	1349-7235
ISSN	0021-5120 ; 0918-2918
DOI	10.2169/internalmedicine.8422-21
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Article: [Antileukemic].

Inomata, Tomoko / Sunami, Kazutaka

Nihon rinsho. Japanese journal of clinical medicine

2015 Volume 73 Suppl 2, Page(s) 191–194

MeSH term(s)	Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Arsenicals/adverse effects ; Arsenicals/therapeutic use ; Benzoates/adverse effects ; Benzoates/therapeutic use ; Humans ; Leukemia/drug therapy ; Oxides/adverse effects ; Oxides/therapeutic use ; Remission Induction ; Tetrahydronaphthalenes/adverse effects ; Tetrahydronaphthalenes/therapeutic use ; Tretinoin/adverse effects ; Tretinoin/therapeutic use
Chemical Substances	Antineoplastic Agents ; Arsenicals ; Benzoates ; Oxides ; Tetrahydronaphthalenes ; tamibarotene (08V52GZ3H9) ; Tretinoin (5688UTC01R) ; arsenic trioxide (S7V92P67HO)
Language	Japanese
Publishing date	2015-02
Publishing country	Japan
Document type	Journal Article
ZDB-ID	390903-7
ISSN	0047-1852
ISSN	0047-1852
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Article: [Induction therapy of transplant-eligible patients in multiple myeloma].

Konishi, Jun / Sunami, Kazutaka

Nihon rinsho. Japanese journal of clinical medicine

2015 Volume 73, Issue 1, Page(s) 90–94

Abstract: There have been major advances in the past decade in induction therapy for transplantation-eligible multiple myeloma (MM) patients. Induction therapy followed by autologous stem cell transplantation (ASCT) is the standard treatment for younger patients ... ...

Abstract	There have been major advances in the past decade in induction therapy for transplantation-eligible multiple myeloma (MM) patients. Induction therapy followed by autologous stem cell transplantation (ASCT) is the standard treatment for younger patients with MM. A high complete response rate has been achieved by three-drug induction regimens including novel agents both before and after ASCT without substantially increasing toxicity. A favorable response to therapy is a very important prognostic factor. This chapter reviews recent results on the most commonly used and tested doublet, triplet, quadruplet combinations for the treatment of newly diagnosed transplantation-eligible myeloma and provides guidance on choosing the optimal initial treatment regimen.
MeSH term(s)	Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Autografts ; Humans ; Induction Chemotherapy/methods ; Multiple Myeloma/drug therapy ; Multiple Myeloma/therapy ; Risk Factors ; Stem Cell Transplantation
Language	Japanese
Publishing date	2015-01
Publishing country	Japan
Document type	English Abstract ; Journal Article
ZDB-ID	390903-7
ISSN	0047-1852
ISSN	0047-1852
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Article ; Online: An observational study of once-weekly carfilzomib in patients with multiple myeloma in Japan (Weekly-CAR study).

Abe, Yu / Kubonishi, Shiro / Ri, Masaki / Iino, Masaki / Sunami, Kazutaka / Ito, Tomoki / Fukaya, Masafumi / Kitano, Toshiyuki / Ikeda, Sho / Ota, Shuichi / Kuroi, Taiga / Iriyama, Noriyoshi / Jo, Tatsuro / Adachi, Masaaki / Akahane, Daigo / Kai, Tatsuyuki / Kohara, Yoichi / Kadowaki, Norimitsu / Katayama, Teruaki

Future oncology (London, England)

2024

Abstract: Background: ...

Abstract	Background:
Language	English
Publishing date	2024-02-29
Publishing country	England
Document type	Journal Article
ZDB-ID	2274956-1
ISSN	1744-8301 ; 1479-6694
ISSN (online)	1744-8301
ISSN	1479-6694
DOI	10.2217/fon-2023-0834
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Article ; Online: Phase II, Multicenter, Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Panobinostat in Combination with Bortezomib and Dexamethasone in Japanese Patients with Relapsed or Relapsed-and-Refractory Multiple Myeloma.

Suzuki, Kenshi / Sunami, Kazutaka / Matsumoto, Morio / Maki, Akio / Shimada, Fumika / Suzuki, Kazuyuki / Shimizu, Kazuyuki

Acta haematologica

2020 Volume 144, Issue 3, Page(s) 264–274

Abstract: Introduction: Panobinostat, bortezomib, and dexamethasone combination therapy demonstrated progression-free survival (PFS) benefit over bortezomib and dexamethasone alone in the PANORAMA-1 study in relapsed/refractory multiple myeloma (MM). Here, we ... ...

Abstract	Introduction: Panobinostat, bortezomib, and dexamethasone combination therapy demonstrated progression-free survival (PFS) benefit over bortezomib and dexamethasone alone in the PANORAMA-1 study in relapsed/refractory multiple myeloma (MM). Here, we present data from a phase II study (NCT02290431) of this combination in Japanese patients with relapsed or relapsed-and-refractory MM. Methods: Patients received 3-week cycles of 20-mg oral panobinostat (weeks 1 and 2), 1.3-mg/m2 subcutaneous bortezomib (days 1, 4, 8, and 11), and 20-mg oral dexamethasone (day of and the day following bortezomib administration) for a total of 8 cycles (24 weeks; treatment phase 1). Patients with treatment benefit had an option to enter the extension phase to receive 6-week (42-day) cycles of panobinostat (weeks 1, 2, 4, and 5) plus bortezomib (days 1, 8, 22, and 29) and dexamethasone (day of and the day following bortezomib treatment) for 24 weeks. The primary objective was complete response (CR) + near CR (nCR) rate after treatment phase 1 as per the modified European Society for Blood and Marrow Transplantation criteria. Results: Of the 31 patients, 4 (12.9%) completed the treatment and 27 (87.1%) discontinued; 17 (54.8%) entered the extension phase. In total, 24 patients (77.4%) entered the survival follow-up phase and followed until study closure when the last patient was treated for 1 year after treatment phase 1. The CR + nCR rate was 48.4% (90% CI: 33.6-63.2). The overall response rate (CR + nCR + partial response) was 80.6%. The median PFS, duration of response, time to response, and time to progression were 15.3, 22.7, 1.4, and 15.3 months, respectively. All patients experienced adverse events (AEs), with diarrhea (80.6%), decreased appetite (58.1%), and thrombocytopenia (54.8%) being the most frequent, regardless of relationship to the study treatment. Thrombocytopenia (48.4%), fatigue (25.8%), diarrhea (22.6%), neutrophil count decrease (22.6%), platelet count decrease (22.6%), and lymphocyte count decrease (22.6%) were the most frequent grade 3/4 AEs. Conclusion: The study met the primary objective with 48.4% CR + nCR rate. The AEs associated with the combination treatment were safely managed using the existing AE management guidelines, including dose interruption/modification and/or supportive medical intervention. This treatment regimen is an effective option with a favorable benefit/risk profile for Japanese patients with relapsed/refractory MM.
MeSH term(s)	Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Bortezomib/administration & dosage ; Bortezomib/pharmacokinetics ; Dexamethasone/administration & dosage ; Dexamethasone/pharmacokinetics ; Diarrhea/etiology ; Drug Administration Schedule ; Half-Life ; Humans ; Japan ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Multiple Myeloma/drug therapy ; Multiple Myeloma/mortality ; Multiple Myeloma/pathology ; Neoplasm Staging ; Panobinostat/administration & dosage ; Panobinostat/pharmacokinetics ; Progression-Free Survival ; Recurrence ; Remission Induction ; Thrombocytopenia/etiology
Chemical Substances	Bortezomib (69G8BD63PP) ; Dexamethasone (7S5I7G3JQL) ; Panobinostat (9647FM7Y3Z)
Language	English
Publishing date	2020-12-04
Publishing country	Switzerland
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	80008-9
ISSN	1421-9662 ; 0001-5792
ISSN (online)	1421-9662
ISSN	0001-5792
DOI	10.1159/000508529
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