Evidence map›Paper›PMID 32297407›Full record

Trial reportCancer science2020

Pomalidomide-bortezomib-dexamethasone in relapsed or refractory multiple myeloma: Japanese subset analysis of OPTIMISMM.

Kazutaka Sunami, Kosei Matsue, Kenshi Suzuki, Naoki Takezako, Atsushi Shinagawa, Sanae Sakurai, Hiromi Tamakoshi, Tsvetan Biyukov, Teresa Peluso, Paul Richardson

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Cancer science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. 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

10 authors.

Kazutaka SunamiDepartment of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.ORCID https://orcid.org/0000-0002-8229-7439
Kosei MatsueDepartment of Hematology, Kameda Medical Center, Chiba, Japan.ORCID https://orcid.org/0000-0002-8669-9865
Kenshi SuzukiDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Naoki TakezakoDepartment of Hematology, National Hospital Organization Disaster Medical Center, Tokyo, Japan.
Atsushi ShinagawaDepartment of Hemato-Oncology, Hitachi General Hospital, Ibaraki, Japan.
Sanae SakuraiDepartment of Clinical Research & Development Study, Celgene KK, a Bristol-Myers Squibb Company, Tokyo, Japan.
Hiromi TamakoshiDepartment of Clinical Research & Development Study, Celgene KK, a Bristol-Myers Squibb Company, Tokyo, Japan.
Tsvetan BiyukovDepartment of Clinical R&D Management, Celgene International Sàrl, a Bristol-Myers Squibb Company, Boudry, Switzerland.
Teresa PelusoDepartment of Clinical R&D Management, Celgene International Sàrl, a Bristol-Myers Squibb Company, Boudry, Switzerland.
Paul RichardsonDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.

Funding

Bristol-Myers Squibb CompanyCelgene
6 · The paper itself

Abstract

In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib and dexamethasone (PVd) significantly improved the progression-free survival (PFS) and the overall response rate (ORR) vs bortezomib and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma. All patients were previously treated with lenalidomide (70% refractory to lenalidomide) and had received one to three prior regimens. Here we report the first efficacy and safety analysis of PVd vs Vd in Japanese patients with relapsed or refractory multiple myeloma. Seventeen patients enrolled in the OPTIMISMM trial in Japan. With a median follow-up of 14.8 months, the median PFS was 17.6 months with PVd (n = 12) vs 4.4 months with Vd (n = 5), and the ORR was 100% vs 60.0%, respectively. The safety profile was as expected for PVd. Toxicities were managed with dose reductions and interruptions, and no patients discontinued PVd due to treatment-emergent adverse events. These results are consistent with those in the overall OPTIMISMM patient population and confirm the clinical benefit of PVd in Japanese patients.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBortezomibDexamethasoneDrug Resistance, NeoplasmFemaleHumansJapanMaleMiddle AgedMultiple MyelomaNeoplasm Recurrence, LocalProgression-Free SurvivalThalidomideTreatment OutcomeBortezomibDexamethasonepomalidomideThalidomideJapanlenalidomide refractoryOPTIMISMMpomalidomiderelapsed or refractory multiple myeloma

Identifiers

PMID32297407
PMCPMC7293071

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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.