Evidence map›Paper›PMID 36862168›Full record

Trial reportAnnals of hematology2023

Daratumumab plus bortezomib, cyclophosphamide, and dexamethasone in Asian patients with newly diagnosed AL amyloidosis: subgroup analysis of ANDROMEDA.

Kenshi Suzuki, Ashutosh D Wechalekar, Kihyun Kim, Chihiro Shimazaki, Jin Seok Kim, Takayuki Ikezoe, Chang-Ki Min, Fude Zhou, Zhen Cai, Xiaonong Chen and 12 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of hematology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.8field-weighted citation impact, top 15% 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.

NCT03201965 phase3completednot on this map

A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

TypeinterventionalSponsorJanssen Research & Development, LLCRan2017 to 2024Enrolled416ConditionsAmyloidosisArmsCyclophosphamide, Bortezomib, Dexamethasone, 40 mg, Daratumumab
NCT06297681 unknown statusnot on this mapstarted 2024, after this paper: background citation

A Cross-sectional Study on the Efficacy and Safety of the Combination of Daratumumab+Bortezomib+Dexamethasone Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease

TypeobservationalSponsorBeijing Chao Yang HospitalRan2024 to 2025Enrolled40ConditionsM-protein Related Cardiac DiseaseArmsDaratumumab + Bortezomib + Dexamethasone + Dapagliflozin
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

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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

22 authors at 18 institutions in 7 countries.

Kenshi SuzukiDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Ashutosh D WechalekarDivision of Medicine, Faculty of Medical Sciences, University College London and the Royal Free London NHS Foundation Trust, London, UK.
Kihyun KimDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Chihiro ShimazakiDepartment of Hematology, Japan Community Health Care Organization, Kyoto Kuramaguchi Medical Center, Kyoto, Japan.
Jin Seok KimYonsei University College of Medicine, Severance Hospital, Seoul, Korea.
Takayuki IkezoeDepartment of Hematology, Fukushima Medical School, Fukushima, Japan.
Chang-Ki MinSeoul St. Mary's Hospital, Seoul, Korea.
Fude ZhouDepartment of Medicine, Peking University First Hospital, Renal Division, Beijing, China.
Zhen CaiCollege of Medicine, The First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China.
Xiaonong ChenDepartment of Nephrology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China.
Shinsuke IidaDepartment of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Nagoya, Japan.
Nagaaki KatohDepartment of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine, Matsumoto, Nagano, Japan.
Tomoaki FujisakiMatsuyama Red Cross Hospital, Matsuyama, Japan.
Ho-Jin ShinDepartment of Internal Medicine, Pusan National University Hospital, Busan, South Korea.
NamPhuong TranJanssen Research & Development, LLC, Los Angeles, CA, USA.
Xiang QinJanssen Research & Development, LLC, Spring House, PA, USA.
Sandra Y VaseyJanssen Research & Development, LLC, Spring House, PA, USA.
Brenda TrompJanssen Biologics B.V., Leiden, The Netherlands.
Brendan M WeissJanssen Research & Development, LLC, Spring House, PA, USA.
Raymond L ComenzoDivision of Hematology/Oncology, John C. Davis Myeloma and Amyloid Program, Tufts Medical Center, Boston, MA, USA.
Efstathios KastritisDepartment of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
Jin LuCollaborative Innovation Center of Hematology, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing, China. jin1lu@sina.com.ORCID http://orcid.org/0000-0001-5004-2741
Janssen (United States) · USPeking University · CNFirst Affiliated Hospital Zhejiang University · CNFukushima Medical University · JPJanssen (Netherlands) · NLJapanese Red Cross Medical Center · JPKyoto Medical Center · JPMatsuyama Red Cross Hospital · JPNagoya City University · JPNational and Kapodistrian University of Athens · GRPusan National University Hospital · KRRoyal Free London NHS Foundation Trust · GBSamsung Medical Center · KRShanghai Jiao Tong University · CNShinshu University · JPThe Catholic University of Korea Seoul St. Mary's Hospital · KRTufts Medical Center · USYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Subcutaneous daratumumab plus bortezomib/cyclophosphamide/dexamethasone (VCd; D-VCd) improved outcomes versus VCd for patients with newly diagnosed immunoglobulin light-chain (AL) amyloidosis in the phase 3 ANDROMEDA study. We report a subgroup analysis of Asian patients (Japan; Korea; China) from ANDROMEDA. Among 388 randomized patients, 60 were Asian (D-VCd, n = 29; VCd, n = 31). At a median follow-up of 11.4 months, the overall hematologic complete response rate was higher for D-VCd versus VCd (58.6% vs. 9.7%; odds ratio, 13.2; 95% confidence interval [CI], 3.3-53.7; P < 0.0001). Six-month cardiac and renal response rates were higher with D-VCd versus VCd (cardiac, 46.7% vs. 4.8%; P = 0.0036; renal, 57.1% vs. 37.5%; P = 0.4684). Major organ deterioration progression-free survival (MOD-PFS) and major organ deterioration event-free survival (MOD-EFS) were improved with D-VCd versus VCd (MOD-PFS: hazard ratio [HR], 0.21; 95% CI, 0.06-0.75; P = 0.0079; MOD-EFS: HR, 0.16; 95% CI, 0.05-0.54; P = 0.0007). Twelve deaths occurred (D-VCd, n = 3; VCd, n = 9). Twenty-two patients had baseline serologies indicating prior hepatitis B virus (HBV) exposure; no patient experienced HBV reactivation. Although grade 3/4 cytopenia rates were higher than in the global safety population, the safety profile of D-VCd in Asian patients was generally consistent with the global study population, regardless of body weight. These results support D-VCd use in Asian patients with newly diagnosed AL amyloidosis. ClinicalTrials.gov Identifier: NCT03201965.

Indexed as

Immunoglobulin Light-chain AmyloidosisMultiple MyelomaAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBortezomibCyclophosphamideDexamethasoneHumansAntibodies, MonoclonalBortezomibCyclophosphamidedaratumumabDexamethasoneAsianBody weightDaratumumabEfficacyLight-chain amyloidosisSafety

Identifiers

PMID36862168
PMCPMC9998577
OpenAlexW4322757994

What OpenQuestion holds

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LicenceCC BY
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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.