Evidence map›Paper›PMID 30701467›Full record

Trial reportInternational journal of hematology2019

Thalidomide maintenance therapy in Japanese myeloma patients: a multicenter, phase II clinical trial (COMET study).

Hirokazu Murakami, Tetsuhiro Kasamatsu, Jun Murakami, Toru Kiguchi, Takeshi Kanematsu, Daisuke Ogawa, Hiroyuki Takamatsu, Hiroshi Handa, Shuji Ozaki, Hirokazu Miki and 6 more

Erratum issuedAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Hirokazu MurakamiDepartment of Laboratory Sciences, Gunma University Graduate School of Health Sciences, Maebashi, Japan. hmura@gunma-u.ac.jp.
Tetsuhiro KasamatsuDepartment of Laboratory Sciences, Gunma University Graduate School of Health Sciences, Maebashi, Japan.
Jun MurakamiDepartment of Hematology, Toyama University Hospital, Toyama, Japan.
Toru KiguchiDepartment of Hematology, Chugoku Central Hospital, Fukuyama, Japan.
Takeshi KanematsuDepartment of Clinical Laboratory, Nagoya University Hospital, Nagoya, Japan.
Daisuke OgawaDepartment of Hematology, Nagasaki Prefectural Shimabara Hospital, Shimabara, Japan.
Hiroyuki TakamatsuDepartment of Hematology, Kanazawa University Hospital, Kanazawa, Japan.
Hiroshi HandaDepartment of Hematology, Gunma University, Maebashi, Japan.
Shuji OzakiDepartment of Hematology, Tokushima Prefectural Central Hospital, Tokushima, Japan.
Hirokazu MikiDivision of Transfusion Medicine and Cell Therapy, Tokushima University Hospital, Tokushima, Japan.
Takeshi TakahashiDepartment of Hematology, Gifu Municipal Hospital, Gifu, Japan.
Takaaki TakeoDepartment of Hematology, Yokkaichi Municipal Hospital, Yokkaichi, Japan.
Tatsuya YamauchiDepartment of Hematology, Toki Municipal General Hospital, Toki, Japan.
Takanobu MorishitaDepartment of Hematology, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Japan.
Hiroshi KosugiDepartment of Hematology, Ogaki Municipal Hospital, Ogaki, Japan.
Kazuyuki ShimizuDepartment of Hematology/Oncology, Higashi Nagoya National Hospital, Nagoya, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A prospective, multicenter, phase II study was performed to assess the efficacy and safety of thalidomide maintenance therapy at different doses in Japanese multiple myeloma (MM) patients. This study included 34 patients (median age, 74 years) who were previously treated with not more than three prior therapies and whose response status was evaluated as at least stable disease. They were randomized into Group A (no maintenance; 12 patients), Group B (50 mg thalidomide maintenance; 12 patients), and Group C (100 mg thalidomide maintenance; 10 patients), respectively. Thalidomide maintenance therapy resulted in improved depth of response in three cases (13.6%) and sustained response after induction therapy in eight cases (36.4%). Two-year progression-free survival (PFS) was 25.0%, 33.3%, and 77.8% in Groups A, B, and C, respectively, and was significantly higher in Group C than in Group A (p = 0.005). There was no difference in the incidence of hematological or non-hematological adverse events between Groups B and C. The current study demonstrates that maintenance with daily thalidomide at 100 mg, but not 50 mg, improved depth of response and prolonged PFS, and that this treatment was feasible for use in Japanese MM patients.

Indexed as

Maintenance ChemotherapyAsian PeopleDisease-Free SurvivalHumansJapanMultiple MyelomaProspective StudiesSurvival RateThalidomideThalidomideAdverse eventsEfficacyMaintenanceMultiple myelomaThalidomide

Identifiers

PMID30701467

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.