Evidence map›Paper›PMID 26732066›Full record

Trial reportBritish journal of haematology2016

A phase 1/2 study of carfilzomib in Japanese patients with relapsed and/or refractory multiple myeloma.

Takashi Watanabe, Kensei Tobinai, Morio Matsumoto, Kenshi Suzuki, Kazutaka Sunami, Tadao Ishida, Kiyoshi Ando, Takaaki Chou, Shuji Ozaki, Masafumi Taniwaki and 8 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 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

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Observational
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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

18 authors.

Takashi WatanabeDepartment of Haematology, National Cancer Centre Hospital, Tokyo, Japan.
Kensei TobinaiDepartment of Haematology, National Cancer Centre Hospital, Tokyo, Japan.
Morio MatsumotoDepartment of Haematology, National Hospital Organization Nishigunma National Hospital, Shibukawa, Japan.
Kenshi SuzukiDepartment of Haematology, Japanese Red Cross Medical Centre, Tokyo, Japan.
Kazutaka SunamiDepartment of Haematology, National Hospital Organization Okayama Medical Centre, Okayama, Japan.
Tadao IshidaDepartment of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Kiyoshi AndoDepartment of Haematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Takaaki ChouDepartment of Internal Medicine, Niigata Cancer Centre Hospital, Niigata, Japan.
Shuji OzakiDepartment of Haematology, Tokushima Prefectural Central Hospital, Tokushima, Japan.
Masafumi TaniwakiDivision of Haematology and Oncology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Naokuni UikeDepartment of Haematology, National Hospital Organization Kyushu Cancer Centre, Fukuoka, Japan.
Hirohiko ShibayamaDepartment of Haematology and Oncology, Osaka University Graduate School of Medicine, Suita, Japan.
Kiyohiko HatakeDepartment of Haematology and Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Koji IzutsuDepartment of Haematology, Toranomon Hospital, Tokyo, Japan.
Takayuki IshikawaDepartment of Haematology, Kobe City Medical Centre General Hospital, Kobe, Japan.
Yoshihisa ShumiyaDepartment of Oncology Clinical Development Planning, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Tomohisa KashiharaDepartment of Oncology Clinical Development Planning, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Shinsuke IidaDepartment of Haematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We conducted a phase 1/2 study of single-agent carfilzomib in Japanese patients with relapsed/refractory multiple myeloma. Safety, pharmacokinetics and pharmacodynamics of carfilzomib were examined in phase 1. The primary endpoint in phase 2 was the overall response rate (ORR). Carfilzomib was administered in a twice-weekly, consecutive-day dosing schedule. In Phase 1, doses of 15 or 20 mg/m(2) were administered on this schedule or 20 mg/m(2) on Days 1 and 2 of Cycle 1 and then 27 mg/m(2) in the 20/27 mg/m(2) cohort. Patients had a median of five prior therapies, including bortezomib and an immunomodulatory agent. The dose level did not reach the maximum tolerated dose. The most common adverse events were haematological. Notably, carfilzomib either induced new hypertension (n = 4) or aggravated previously existing hypertension (n = 6) in 10 of 50 patients. Four of the eight patients who previously experienced peripheral neuropathy (PN) experienced a recurrence with carfilzomib use, but no new cases of PN occurred. The ORR of the 20/27 mg/m(2) 40 patient cohort was similar to that in the pivotal US study. The dose was efficacious and tolerable in heavily pre-treated Japanese patients; however, meticulous control of hypertension may be necessary for further carfilzomib use.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsCardiovascular DiseasesDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansMaleMiddle AgedMultiple MyelomaNeoplasm StagingOligopeptidesPeripheral Nervous System DiseasesRecurrenceAntineoplastic AgentscarfilzomibOligopeptidescardiovascular AEscarfilzomibhypertension peripheral neuropathymultiple myeloma

Identifiers

PMID26732066
PMCPMC4785611

What OpenQuestion holds

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Registered trials

None linked

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.