Evidence map›Paper›PMID 27738809›Full record

Trial reportCancer chemotherapy and pharmacology2016

A phase II trial of small-dose bortezomib, lenalidomide and dexamethasone (sVRD) as consolidation/maintenance therapy in patients with multiple myeloma.

Soushi Ibata, Tsutomu Sato, Hiroyuki Kuroda, Yasuhiro Nagamachi, Satoshi Iyama, Akihito Fujimi, Yusuke Kamihara, Yuichi Konuma, Masahiro Yoshida, Ayumi Tatekoshi and 9 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 30% 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.

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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Review
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

19 authors at 5 institutions in 1 country.

Soushi IbataDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Tsutomu SatoDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan. tsutomus@sapmed.ac.jp.
Hiroyuki KurodaGastroenterology and Hematology/Clinical Oncology, Internal Medicine, Steel Memorial Muroran Hospital, Muroran, Japan.
Yasuhiro NagamachiDepartment of Hematology, Kiyota Hospital, Sapporo, Japan.
Satoshi IyamaDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Akihito FujimiDepartment of Hematology and Oncology, Oji General Hospital, Tomakomai, Japan.
Yusuke KamiharaDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Yuichi KonumaDepartment of Hematology and Oncology, Asahikawa Red Cross Hospital, Asahikawa, Japan.
Masahiro YoshidaDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Ayumi TatekoshiDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Akari HashimotoDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Hiroto HoriguchiDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Kaoru OnoDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Kazuyuki MuraseDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Kohichi TakadaDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Koji MiyanishiDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Masayoshi KobuneDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Yasuo HirayamaDivision of Internal Medicine, Higashi Sapporo Hospital, Sapporo, Japan.
Junji KatoDepartment of Medical Oncology and Hematology, Sapporo Medical University School of Medicine, South-1 West-16, Chuo-ku, Sapporo, Japan.
Sapporo Medical University · JPHokkaido Sapporo Kiyota High School · JPJapanese Red Cross Asahikawa Hospital · JPMuroran Institute of Technology · JPOji General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeConsolidation/maintenance therapy induces deep remission in patients with multiple myeloma (MM); however, the most suitable regimen has been under investigation. The combination therapy with bortezomib, lenalidomide and dexamethasone (VRD) is a powerful regimen for relapsed/refractory as well as newly diagnosed MM as an induction therapy. However, severe adverse events (AEs) may become a problem when VRD is introduced without dose reduction as a consolidation/maintenance therapy.

methodsIn this single-arm phase II study, we evaluated the efficacy of small-dose VRD regimen (sVRD) in the consolidation/maintenance setting. Sixteen patients who had partial response (PR) or better after any induction therapy were enrolled. Patients received at least six 28-day cycles of subcutaneous bortezomib (1.3 mg/m

resultsThe overall response rate and the complete response (CR) rate were 100 and 43.8 %, respectively. In particular, one patient with CR and two patients with very good PR at enrollment achieved stringent CR during 6 courses of sVRD. With a median follow-up time of 29.4 months, the median progression-free survival (PFS) and overall survival (OS) were not reached, while the PFS and OS rates at 2.5 years were 66.6 and 77.3 %, respectively. Univariate analysis demonstrated that disease progression as a reason for discontinuation of sVRD had a negative impact on OS. There were no grade 3 or 4 hematologic or nonhematologic AEs.

conclusionOur sVRD regimen as a consolidation/maintenance therapy was highly effective and well tolerable.

Indexed as

AgedAngiogenesis InhibitorsAntineoplastic AgentsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBortezomibDexamethasoneDisease-Free SurvivalFemaleHumansKaplan-Meier EstimateLenalidomideMaleMiddle AgedMultiple MyelomaNeoplasms, Second PrimaryAngiogenesis InhibitorsAntineoplastic AgentsAntineoplastic Agents, HormonalBortezomibDexamethasoneLenalidomideThalidomideBortezomibConsolidation/maintenanceDexamethasoneLenalidomideMultiple myelomaVRD

Identifiers

PMID27738809
PMCPMC5083756
OpenAlexW2530787370

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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.