Evidence map›Paper›PMID 32244252›Full record

Trial reportBlood2020

Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA.

Giovanni Palladini, Efstathios Kastritis, Mathew S Maurer, Jeffrey Zonder, Monique C Minnema, Ashutosh D Wechalekar, Arnaud Jaccard, Hans C Lee, Naresh Bumma, Jonathan L Kaufman and 10 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Blood, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 95 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 1 pooled it
13.0field-weighted citation impact, top 1% 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
NCT04943302 phase2withdrawnnot on this mapstarted 2022, after this paper: background citation

Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis

TypeinterventionalSponsorTufts Medical CenterRan2022 to 2026Enrolled0ConditionsAmyloidosis, Light Chain (AL) AmyloidosisArmsBendamustine Hydrochloride, Isatuximab
NCT07021677 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia - A Phase 2 Study

TypeinterventionalSponsorTata Memorial CentreRan2023 to 2026Enrolled18ConditionsT Acute Lymphoblastic LeukemiaArmsDaratumumab Injection
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 1 synthesis or guideline pooled it, 207 citations in OpenAlex.

  1. Global epidemiology of amyloid light-chain amyloidosis.Orphanet journal of rare diseases · 2022
    Pooled it
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  17. Cardiac amyloidosis: Innovations in diagnosis and treatment.European heart journal supplements : journal of the European Society of Cardiology · 2025
    Article
  18. Review
  19. Onconephrology.Advances in kidney disease and health · 2025
    Review
  20. Article

35 more citing papers are in PubMed but not listed here.

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

20 authors at 17 institutions in 6 countries.

Giovanni PalladiniAmyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy.
Efstathios KastritisDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Mathew S MaurerColumbia University Irving Medical Center, New York, NY.
Jeffrey ZonderBarbara Ann Karmanos Cancer Institute, Detroit, MI.
Monique C MinnemaDepartment of Hematology, University Medical Center Utrecht, Utrecht, The Netherlands.
Ashutosh D WechalekarDivision of Medicine, Faculty of Medical Sciences, University College London, London, United Kingdom.
Arnaud JaccardCentre Hospitalier Universitaire and Reference Center for AL Amyloidosis, Limoges, France.
Hans C LeeDivision of Cancer Medicine, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.
Naresh BummaDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, OH.
Jonathan L KaufmanWinship Cancer Institute, Emory University, Atlanta, GA.
Eva MedvedovaOregon Health & Science University, Portland, OR.
Tibor KovacsovicsDivision of Hematology and Hematologic Malignancies, University of Utah School of Medicine, and the Huntsman Cancer Institute, Salt Lake City, UT.
Michael RosenzweigDepartment of Hematology and Hematopoietic Cell Transplantation, Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope, Duarte, CA.
Vaishali SanchorawalaDepartment of Medicine and Amyloidosis Center, Boston University School of Medicine and Boston Medical Center, Boston, MA.
Xiang QinJanssen Research & Development, LLC, Spring House, PA.
Sandra Y VaseyJanssen Research & Development, LLC, Spring House, PA.
Brendan M WeissJanssen Research & Development, LLC, Spring House, PA.
Jessica VermeulenJanssen Research & Development, Leiden, The Netherlands; and.
Giampaolo MerliniAmyloidosis Research and Treatment Center, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, Pavia, Italy.
Raymond L ComenzoDivision of Hematology/Oncology, John C. Davis Myeloma and Amyloid Program, Tufts Medical Center, Boston, MA.
Janssen (United States) · USUniversity of Pavia · ITBoston University · USCentre Hospitalier Universitaire de Limoges · FRCity of Hope · USColumbia University Irving Medical Center · USEmory University · USFaculty (United Kingdom) · GBJanssen (Netherlands) · NLNational and Kapodistrian University of Athens · GROregon Health & Science University · USThe Barbara Ann Karmanos Cancer Institute · USThe Ohio State University · USThe University of Texas MD Anderson Cancer Center · USTufts Medical Center · USUniversity Medical Center Utrecht · NLUniversity of Utah · US

Funding

Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
NCATS NIH HHS UL1 TR003167
6 · The paper itself

Abstract

Although no therapies are approved for light chain (AL) amyloidosis, cyclophosphamide, bortezomib, and dexamethasone (CyBorD) is considered standard of care. Based on outcomes of daratumumab in multiple myeloma (MM), the phase 3 ANDROMEDA study (NCT03201965) is evaluating daratumumab-CyBorD vs CyBorD in newly diagnosed AL amyloidosis. We report results of the 28-patient safety run-in. Patients received subcutaneous daratumumab (DARA SC) weekly in cycles 1 to 2, every 2 weeks in cycles 3 to 6, and every 4 weeks thereafter for up to 2 years. CyBorD was given weekly for 6 cycles. Patients had a median of 2 involved organs (kidney, 68%; cardiac, 61%). Patients received a median of 16 (range, 1-23) treatment cycles. Treatment-emergent adverse events were consistent with DARA SC in MM and CyBorD. Infusion-related reactions occurred in 1 patient (grade 1). No grade 5 treatment-emergent adverse events occurred; 5 patients died, including 3 after transplant. Overall hematologic response rate was 96%, with a complete hematologic response in 15 (54%) patients; at least partial response occurred in 20, 22, and 17 patients at 1, 3, and 6 months, respectively. Renal response occurred in 6 of 16, 7 of 15, and 10 of 15 patients, and cardiac response occurred in 6 of 16, 6 of 13, and 8 of 13 patients at 3, 6, and 12 months, respectively. Hepatic response occurred in 2 of 3 patients at 12 months. Daratumumab-CyBorD was well tolerated, with no new safety concerns versus the intravenous formulation, and demonstrated robust hematologic and organ responses. This trial was registered at www.clinicaltrials.gov as #NCT03201965.

Indexed as

Acute Kidney InjuryAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsBortezomibCellulitisCyclophosphamideDexamethasoneFemaleFollow-Up StudiesHumansImmunoglobulin Heavy ChainsImmunoglobulin Light-chain AmyloidosisImmunoglobulin Light ChainsAntibodies, MonoclonalBortezomibCyclophosphamidedaratumumabDexamethasoneImmunoglobulin Heavy ChainsImmunoglobulin Light Chains

Identifiers

PMID32244252
PMCPMC7332897
OpenAlexW3014227371

What OpenQuestion holds

Textmetadata
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.