Evidence map›Paper›PMID 26914369›Full record

Trial reportCancer science2016

Lenalidomide and low-dose dexamethasone in Japanese patients with newly diagnosed multiple myeloma: A phase II study.

Kenshi Suzuki, Atsushi Shinagawa, Toshiki Uchida, Masafumi Taniwaki, Hirokazu Hirata, Kenichi Ishizawa, Kosei Matsue, Yoshiaki Ogawa, Takayuki Shimizu, Maki Otsuka and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01698801 (A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% of its field
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.

NCT01698801 phase2completednot on this map

A Phase 2, Multicenter, Open-label, Single Arm Study of Lenalidomide (CC-5013) in Combination With Low-dose Dexamethasone in Japanese Patients With Previously Untreated Multiple Myeloma

TypeinterventionalSponsorCelgeneRan2012 to 2018Enrolled26ConditionsMultiple MyelomaArmsLenalidomide, dexamethasone
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. 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

21 authors at 16 institutions in 1 country.

Kenshi SuzukiJapanese Red Cross Medical Center, Tokyo, Japan.
Atsushi ShinagawaHitachi General Hospital, Hitachi, Japan.
Toshiki UchidaJapanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
Masafumi TaniwakiUniversity Hospital, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Hirokazu HirataDepartment of Hematology, Kansai Electric Power Hospital, Osaka, Japan.
Kenichi IshizawaDepartment of Hematology and Cell Therapy, Yamagata University Faculty of Medicine, Yamagata, Japan.
Kosei MatsueKameda General Hospital, Kamogawa, Japan.
Yoshiaki OgawaTokai University Hospital, Isehara, Japan.
Takayuki ShimizuDivision of Hematology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
Maki OtsukaNational Hospital Organization Kagoshima Medical Center, Kagoshima, Japan.
Morio MatsumotoNational Hospital Organization Nishigunma National Hospital, Shibukawa, Japan.
Shinsuke IidaNagoya City University Hospital, Nagoya, Japan.
Yasuhito TeruiThe Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Itaru MatsumuraFaculty of Medicine, Kinki University Hospital, Osakasayama, Japan.
Takashi IkedaShizuoka Cancer Center, Sunto, Japan.
Naoki TakezakoNational Hospital Organization Disaster Medical Center, Tachikawa, Japan.
Yumi OgakiCelgene K.K., Tokyo, Japan.
Shuichi MidorikawaCelgene K.K., Tokyo, Japan.
Vanessa HouckCelgene Corporation, Summit, NJ, USA.
Annette Ervin-HaynesCelgene Corporation, Summit, NJ, USA.
Takaaki ChouNiigata Cancer Center Hospital, Niigata, Japan.
National Hospital Organization · JPHitachi General Hospital · JPJapanese Red Cross Medical Center · JPJapanese Red Cross Nagoya Daini Hospital · JPKameda Medical Center · JPKansai Electric Power Hospital · JPKeio University · JPKindai University Hospital · JPNagoya City University Hospital · JPNational Disaster Medical Center · JPNiigata Cancer Center Hospital · JPShizuoka Cancer Center · JPThe Cancer Institute Hospital · JPTokai University Hospital · JPUniversity Hospital Kyoto Prefectural University of Medicine · JPYamagata University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the FIRST trial (MM-020), lenalidomide plus low-dose dexamethasone (Rd) reduced the risk of disease progression or death compared with combination melphalan-prednisone-thalidomide. As the FIRST trial did not include any Japanese patients, the efficacy and safety of continuous treatment with Rd was evaluated in 26 Japanese patients with newly diagnosed multiple myeloma (NDMM) in a single-arm, multicenter, open-label phase II trial (MM-025). Patients received lenalidomide on days 1-21 of each 28-day cycle, with a starting dose of 25 mg/day (dose adjusted for renal impairment), and 40 mg/day dexamethasone (dose adjusted for age) on days 1, 8, 15 and 22 of each 28-day cycle until disease progression or discontinuation for any reason. In the efficacy evaluable population, overall response rate was 87.5%, including 29.2% of patients who achieved a complete response/very good partial response. Median durations of response, progression-free survival and overall survival have not been reached. The most common grade 3-4 adverse events were neutropenia (23%) and anemia (19%). The efficacy and safety of Rd were consistent with data from larger studies, including the FIRST trial, thereby supporting the use of Rd continuous in Japanese patients with NDMM who are ineligible for stem cell transplantation.

Indexed as

AgedAged, 80 and overDexamethasoneDisease ProgressionFemaleHumansJapanKaplan-Meier EstimateLenalidomideMaleMiddle AgedMultiple MyelomaSurvival AnalysisThalidomideDexamethasoneLenalidomideThalidomideDexamethasoneJapanJapaneselenalidomidemultiple myeloma

Identifiers

PMID26914369
PMCPMC4970832
OpenAlexW2287798315

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.