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Promising combo therapy targets rare protein disease in major trial

NCT ID NCT03201965

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding daratumumab to standard chemotherapy (CyBorD) helps people newly diagnosed with AL amyloidosis, a rare disease where abnormal proteins build up in organs. About 416 adults took part. The goal was to see if the combination leads to better blood responses and slows organ damage. Results may offer a more effective treatment option for this serious condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

416 people

The number who actually took part.

Started

Oct 2017

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance * Measurable disease of amyloid light-chain (AL) amyloidosis as defined by at least one of the following: 1. serum monoclonal (M)-protein greater than or equal (\>=) 0.5 grams/deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation \[IFE\] performed at a central laboratory) 2. serum free light chain greater than or equal to (\>=) 50 milligram/Liter (mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) \>= 50 mg/L * One or more organs impacted by AL amyloidosis according to consensus guidelines * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 Exclusion Criteria: * Prior therapy for AL amyloidosis or multiple myeloma including medications that target CD38, with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to randomization * Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, \>= 60 percent (%) plasma cells in the bone marrow, or hypercalcemia * Evidence of significant cardiovascular conditions as specified below: 1. NT-ProBNP \> 8500 nanogram per liter (ng/L) 2. New York Heart Association (NYHA) classification IIIB or IV heart failure 3. Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (eg, prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram \[ECG\] changes) or uncorrected valvular disease and not primarily due to AL amyloid cardiomyopathy 4. Inpatient admission to a hospital for unstable angina or myocardial infarction within the last 6 months prior to first dose or percutaneous cardiac intervention with recent stent within 6 months or coronary artery bypass grafting within 6 months 5. For participants with congestive heart failure, cardiovascular-related hospitalizations within 4 weeks prior to randomization 6. Participants with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular (AV) nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillators \[ICD\] is indicated but not placed (participants who do have a pacemaker/ICD are allowed on study) 7. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \> 500 milliseconds (msec). Participants who have a pacemaker may be included regardless of calculated QTc interval 8. Supine systolic blood pressure \< 90 millimeter of mercury (mmHg), or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of \> 20 mmHg despite medical management (eg, midodrine, fludrocortisones) in the absence of volume depletion * Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted * Known to be seropositive for human immunodeficiency virus (HIV) * Any one of the following: 1. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Participants with resolved infection (ie, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded 2. Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy) * Grade 2 sensory or Grade 1 painful peripheral neuropathy

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Conditions

The condition(s) this trial relates to.

amyloidosis primary systemic amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyloidosis

Contacts and locations

Locations

  • A.O.U. Città della Salute e della Scienza

    Torino, 10126, Italy

  • Aarhus University Hospital

    Aarhus N, DK-8200, Denmark

  • Akdeniz University Medical Faculty

    Antalya, 7059, Turkey (Türkiye)

  • Alberta Health Services

    Edmonton, Alberta, T6G 1Z2, Canada

  • Alexandra General Hospital of Athens

    Athens, 11528, Greece

  • Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

    Ankara, 06590, Turkey (Türkiye)

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Assaf Ha'Rofeh Medical Center

    Ẕerifin, 70300, Israel

  • Az Groeninge

    Kortrijk, 8500, Belgium

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Boston University Medical Center

    Boston, Massachusetts, 02118, United States

  • Box Hill Hospital

    Box Hill, 3128, Australia

  • CHU Bretonneau

    Tours, 37044, France

  • CHU De Poitiers

    Poitiers, 86000, France

  • CHU Dijon

    Dijon, 21000, France

  • CHU Rangueil

    Toulouse, 31400, France

  • CHU de Limoges - Fédération Hépatologie

    Limoges, 87000, France

  • CHU de Nancy_ Hopital Brabois

    Vandœuvre-lès-Nancy, 54511, France

  • Carmel Hospital

    Haifa, 34362, Israel

  • Casa di Cura La Maddalena

    Palermo, 90146, Italy

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495, France

  • Centro de Investigación Farmacéutica Especializada

    Guadalajara, 44160, Mexico

  • Charite Campus Benjamin Franklin

    Berlin, 12203, Germany

  • Chu Hotel Dieu

    Nantes, 44035, France

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica Sao Germano

    São Paulo, 01455 010, Brazil

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418, United States

  • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

    Budapest, 1097, Hungary

  • Dep. of Hematology, Rigshospitalet

    Copenhagen, 2400, Denmark

  • Dipartimento Di Biotecnologie Cellulari Ed Ematologia-Università ''La Sapienza'',Policlinico Umberto I

    Roma, 00161, Italy

  • Dokuz Eylul Universitesi Tip Fakultesi

    Izmir, 35340, Turkey (Türkiye)

  • Erasmus MC

    Rotterdam, 3015 CN, Netherlands

  • Erciyes University Medical Faculty

    Talas, 38039, Turkey (Türkiye)

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310020, China

  • Fukushima Medical University Hospital

    Fukushima, 960 1295, Japan

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    São José do Rio Preto, 15090-000, Brazil

  • HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH

    Hamburg, 22767, Germany

  • Hadassah Medical Center

    Jerusalem, 91120, Israel

  • Haga ziekenhuis

    The Hague, 2545 AA, Netherlands

  • Heinrich-Heine-Universität Düsseldorf

    Düsseldorf, 40225, Germany

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, 730-8619, Japan

  • Hopital Claude Huriez

    Lille, 59037, France

  • Hopital Saint Louis

    Paris, 75475, France

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hosp. Univ. Dr. Peset

    Valencia, 46017, Spain

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034, Spain

  • Hosp. Univ. de Canarias

    San Cristóbal de La Laguna, 38320, Spain

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-010, Brazil

  • Hospital Sao Rafael

    Salvador, 41253 190, Brazil

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460, Mexico

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903, Brazil

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Inst. Cat. D'Oncologia-Badalona

    Badalona, 08916, Spain

  • Institut Jules Bordet

    Anderlecht, 1070, Belgium

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

    São Paulo, 04039-004, Brazil

  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

    Rio de Janeiro, 22775 001, Brazil

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02 776, Poland

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093, Turkey (Türkiye)

  • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

    Bologna, 40138, Italy

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935, Japan

  • Kanazawa University Hospital

    Kanazawa, 920 8641, Japan

  • Kumamoto University Hospital

    Kumamoto, 860-8556, Japan

  • Kyoto Kuramaguchi Medical Center

    Kyoto, 603-8151, Japan

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • London Health Sciences Center

    London, Ontario, N6A 5W9, Canada

  • Matsuyama Red Cross Hospital

    Matsuyama, 790-8524, Japan

  • Maxima Medisch Centrum

    Veldhoven, 5504 DB, Netherlands

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Nagoya City University Hospital

    Nagoya, 467 8602, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192, Japan

  • Odense Universitets Hospital

    Odense, 5000, Denmark

  • Ondokuz Mayis Universitesi Tip Fakultesiy

    Atakum, 55270, Turkey (Türkiye)

  • Oregon Health And Science University

    Portland, Oregon, 97239, United States

  • Peking University First Hospital

    Beijing, 100034, China

  • Peking University People s Hospital

    Beijing, 100044, China

  • Policlinico di Bari

    Bari, 70124, Italy

  • Princess Alexandra Hospital

    Woolloongabba, 4102, Australia

  • Pusan National University Hospital

    Busan, 49241, South Korea

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025, China

  • SKPP UM w Poznaniu

    Poznan, 60-569, Poland

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023, United States

  • Semmelweis Egyetem I.Belgyogyaszati Klinika

    Budapest, 1083, Hungary

  • Semmelweis Egyetem I.Belgyogyaszati Klinika

    Budapest, 1088, Hungary

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Shinshu University Hospital

    Matsumoto, 390 8621, Japan

  • Sir Charles Gairdner Hospital

    Nedlands, 6009, Australia

  • Skanes universitetssjukhus

    Lund, 221 85, Sweden

  • Sociedade Pernambucana de Combate ao Cancer

    Recife, 50040-000, Brazil

  • Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • South Elvsborg Hospital

    Borås, 501 82, Sweden

  • Stanford University

    Stanford, California, 94305, United States

  • Teine Keijinkai Hospital

    Hokkaido, 006-8555, Japan

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000, China

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Tokushima University Hospital

    Tokushima, 770-8503, Japan

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • UMC Utrecht

    Utrecht, 3584 CX, Netherlands

  • UMCG

    Groningen, 9713 GZ, Netherlands

  • UZ Gent

    Ghent, 9000, Belgium

  • Universitaetsklinikum Heidelberg Medizinische Klinik V

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

    Tübingen, 72076, Germany

  • Universitair Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • Universitatsklinikum Essen

    Essen, 45122, Germany

  • University College Hospital

    London, NW1 2PG, United Kingdom

  • University General Hospital of Rio

    Pátrai, 26500, Greece

  • University Health Network UHN Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • University Hospitals Birmingham NHS Trust,

    Birmingham, B15 2TH, United Kingdom

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii

    Würzburg, 97080, Germany

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences - Cardiovascular Medicine

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School Of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Westmead Hospital

    Westmead, 2145, Australia

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.