Evidence map›Paper›PMID 30937622›Full record

Trial reportInternational journal of clinical oncology2019

Bortezomib-based strategy with autologous stem cell transplantation for newly diagnosed multiple myeloma: a phase II study by the Japan Study Group for Cell Therapy and Transplantation (JSCT-MM12).

Kazutaka Sunami, Morio Matsumoto, Shin-Ichi Fuchida, Eijiro Omoto, Hiroyuki Takamatsu, Yoko Adachi, Ilsong Choi, Naohito Fujishima, Toru Kiguchi, Toshihiro Miyamoto and 10 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Kazutaka SunamiDepartment of Hematology, National Hospital Organization Okayama Medical Center, 1711-1 Tamasu, Kita-ku, Okayama, 701-1192, Japan. kazusuna@pop12.odn.ne.jp.ORCID http://orcid.org/0000-0002-8229-7439
Morio MatsumotoDepartment of Hematology, National Hospital Organization Shibukawa Medical Center, 383 Shirai, Shibukawa, Gunma, 377-0280, Japan.
Shin-Ichi FuchidaDepartment of Hematology, Japan Community Health Care Organization Kyoto Kuramaguchi Medical Center, 27 Shimofusa-cho, Koyama, Kita-ku, Kyoto, 603-8151, Japan.
Eijiro OmotoDepartment of Hematology, Yamagata Prefectural Central Hospital, 1800 Aoyagi, Yamagata, 990-2292, Japan.
Hiroyuki TakamatsuDepartment of Hematology/Respiratory Medicine, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, 13-1 Takaramachi, Kanazawa, Ishikawa, 920-8641, Japan.
Yoko AdachiDepartment of Internal Medicine, Japan Community Health Care Organization Kobe Central Hospital, 2-1-1 Soyama-cho, Kita-ku, Kobe, Hyogo, 651-1145, Japan.
Ilsong ChoiDepartment of Hematology, National Hospital Organization Kyushu Cancer Center, 3-1-1, Notame, Minami-ku, Fukuoka, 811-1395, Japan.
Naohito FujishimaDivision of Blood Transfusion, Akita University Hospital, 1-1-1 Hondo, Akita, 010-8543, Japan.
Toru KiguchiDepartment of Hematology, Chugoku Central Hospital, 148-13 Kamiiwanari, Miyuki-cho, Fukuyama, Hiroshima, 720-0001, Japan.
Toshihiro MiyamotoMedicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Akio MaedaDepartment of Hematology, Hyogo Cancer Center, 13-70 Kitaoji-cho, Akashi, Hyogo, 673-8558, Japan.
Junji SuzumiyaInnovative Cancer Center/Oncology-Hematology, Shimane University Hospital, 89-1 Enya, Izumo, Shimane, 693-8501, Japan.
Ryosuke YamamuraDepartment of Hematology, Osaka Saiseikai Nakatsu Hospital, 2-10-39 Shibata, Kitaku, Osaka, 530-0012, Japan.
Koji NagafujiDivision of Hematology and Oncology, Department of Medicine, Kurume University School of Medicine, 67 Asahicho, Kurume, Fukuoka, 830-0011, Japan.
Tomonori NakazatoDepartment of Hematology, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8555, Japan.
Yoshiaki KurodaDepartment of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8553, Japan.
Toshiaki YujiriThird Department of Internal Medicine, Yamaguchi University School of Medicine, 1-1-1 Minamikogushi, Ube, Yamaguchi, 755-8505, Japan.
Yasushi TakamatsuDivision of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0006, Japan.
Mine HaradaKaratsu Higashimatsuura Medical Association, 2566-11 Chiyodacho, Karatsu, Saga, 847-0041, Japan.
Koichi AkashiMedicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Japan Study Group for Cell Therapy and Transplantation (JSCT) organized a phase II study to evaluate the efficacy and safety of a treatment protocol (JSCT-MM12) for multiple myeloma (MM) patients who were previously untreated and transplantation-eligible. Since bortezomib-based therapy is known to be effective for MM, the protocol is intensified more than the previous protocol (JSCT-MM10) and comprised the subsequent treatments: bortezomib + cyclophosphamide + dexamethasone (VCD) induction; bortezomib + high-dose-melphalan (B-HDM) conditioning with autologous stem cell transplantation (ASCT); bortezomib + thalidomide + dexamethasone (VTD) consolidation; and lenalidomide (LEN) maintenance.

methodsSixty-four symptomatic patients aged between 20 and 65 years were enrolled for treatment and received three cycles of VCD, followed by cyclophosphamide administration for autologous stem cell harvest and B-HDM/ASCT, and subsequently two cycles of VTD, after that LEN for 1 year.

resultsComplete response (CR)/stringent CR (sCR) rates for induction, ASCT, consolidation, and maintenance therapies were 20, 39, 52, and 56%, respectively. The grade 3/4 toxicities (≥ 10%) with VCD treatment included neutropenia (27%), anemia (19%), and thrombocytopenia (11%). There was no treatment-related mortality. After median follow-up of 41 months, estimated 3-year progression-free survival (PFS) and overall survival (OS) rates were 64% and 88%, respectively. The high-risk group revealed lower CR/sCR, PFS, and OS than the standard-risk group.

conclusionsThe study revealed that the treatment protocol consisting of VCD induction, B-HDM/ASCT followed by VTD consolidation, and LEN maintenance could produce highly beneficial responses and favorable tolerability in newly diagnosed MM. However, future study is required for improving treatment in the high-risk group.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBortezomibCombined Modality TherapyCyclophosphamideDexamethasoneFemaleHumansJapanLenalidomideMaleMelphalanMiddle AgedMultiple MyelomaNeoadjuvant TherapyBortezomibCyclophosphamideDexamethasoneLenalidomideMelphalanThalidomideAutologous stem cell transplantationBortezomibConsolidationLenalidomideMaintenanceThalidomide

Identifiers

PMID30937622

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.