Evidence map›Paper›PMID 31701481›Full record

Trial reportInternational journal of hematology2020

Elotuzumab plus lenalidomide and dexamethasone for newly diagnosed multiple myeloma: a randomized, open-label, phase 2 study in Japan.

Kohmei Kubo, Mitsuo Hori, Kensuke Ohta, Hiroshi Handa, Kiyohiko Hatake, Morio Matsumoto, Shotaro Hagiwara, Kazuteru Ohashi, Chiaki Nakaseko, Kenshi Suzuki and 5 more

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

Trial report in International journal of hematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

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

  1. Pooled it
  2. Pooled it
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Emerging agents and regimens for multiple myeloma.Journal of hematology & oncology · 2020
    Review
  10. Article
  11. 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

15 authors.

Kohmei KuboDepartment of Hematology, Aomori Prefectural Central Hospital, 2-1-1 Higashi-Tsukurimichi, Aomori, 030-8553, Japan. komei.kubo@nifty.com.
Mitsuo HoriDepartment of Hematology, Ibaraki Prefectural Central Hospital, Kasama, Japan.
Kensuke OhtaDepartment of Hematology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan.
Hiroshi HandaDepartment of Hematology, Gunma University Hospital, Maebashi, Japan.
Kiyohiko HatakeDepartment of Lymphoma/Hematologic Malignancy Center, Mita Hospital, International University of Health and Welfare, Tokyo, Japan.
Morio MatsumotoDepartment of Hematology, National Hospital Organization Shibukawa Medical Center, Shibukawa, Japan.
Shotaro HagiwaraDivision of Hematology, Internal Medicine, National Center for Global Health and Medicine Hospital, Tokyo, Japan.
Kazuteru OhashiHematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Chiaki NakasekoDepartment of Hematology, Chiba University Hospital, Chiba, Japan.
Kenshi SuzukiDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Shigeki ItoDepartment of Clinical Oncology, Iwate Medical University Hospital, Morioka, Japan.
Gen KinoshitaBristol-Myers Squibb K.K., Tokyo, Japan.
Suresh G ShelatBristol-Myers Squibb, Princeton, NJ, USA.
Masafumi MiyoshiBristol-Myers Squibb K.K., Tokyo, Japan.
Naoki TakezakoDepartment of Hematology, National Hospital Organization Disaster Medical Center, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Novel therapies are needed for patients with newly diagnosed multiple myeloma (NDMM). Elotuzumab plus lenalidomide and dexamethasone (ELd) is approved for the treatment of relapsed/refractory multiple myeloma (RRMM). This phase 2 study in Japan evaluated ELd vs lenalidomide and dexamethasone (Ld) in patients with NDMM who were ineligible for stem cell transplantation. Elotuzumab infusion was accelerated to 5 mL/min by dose 3, cycle 1, allowing most subsequent infusions to be completed within 1 h. The primary endpoint was overall response rate (ORR) in the ELd arm. Secondary endpoints were the difference in ORR between treatments, and progression-free survival (PFS). Patients were randomized to ELd (n = 40) or Ld (n = 42); median number of treatment cycles was 13 (ELd) and 12 (Ld). In the ELd arm, ORR was 88% [70% confidence interval (CI) 80-93]. The estimated difference in ORR between treatments was 13% (95% CI  - 4, 30) in favor of ELd. Progression-free survival data were immature. Safety was consistent with previous findings of ELd in Japanese patients with RRMM. No infusion reactions occurred at the maximum rate of 5 mL/min, which was used in 89% of elotuzumab infusions. ELd may be an effective, well-tolerated frontline treatment for patients with NDMM ineligible for stem cell transplantation.

Indexed as

AgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneDrug Administration ScheduleFemaleHumansJapanLenalidomideMaleMiddle AgedMultiple MyelomaProgression-Free SurvivalStem Cell TransplantationTreatment OutcomeAntibodies, Monoclonal, HumanizedDexamethasoneelotuzumabLenalidomideElotuzumabMultiple myelomaNewly diagnosedStem cell transplantation-ineligible

Identifiers

PMID31701481

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.