AzTrials
AzTrials

AmyloidosisPhase 3NCT03201965

A 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 Amyloid Light-chain (AL) Amyloidosis

A Phase 3 study testing Cyclophosphamide, Bortezomib and Dexamethasone, 40 mg in people with Amyloidosis, run by Janssen Research & Development, LLC at 140 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyloidosis
What is being tested?
Cyclophosphamide, Bortezomib and Dexamethasone, 40 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
140 sitesin 22 countries
Study dates
5 Oct 2017to 19 Nov 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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)
  • 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

Who cannot join

  • 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:
  • NT-ProBNP > 8500 nanogram per liter (ng/L)
  • New York Heart Association (NYHA) classification IIIB or IV heart failure
  • 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
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  • 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
  • For participants with congestive heart failure, cardiovascular-related hospitalizations within 4 weeks prior to randomization
  • 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)
  • 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
  • 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:
  • 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
  • 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

Trial locations and contacts

140 sites in 22 countries.

140 sites in 22 countries

United States29 sites

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Maryland

    Baltimore, Maryland, 21201

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5418

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Columbia University Medical Center

    New York, New York, 10032

  • Weill Cornell Medical College

    New York, New York, 10065

  • University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Oregon Health And Science University

    Portland, Oregon, 97239

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of California San Francisco

    San Francisco, California, 94143

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109-1023

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • Stanford University

    Stanford, California, 94305

  • Wake Forest University Health Sciences - Cardiovascular Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Japan12 sites

  • Fukushima Medical University Hospital

    Fukushima, 960 1295

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, 730-8619

  • Teine Keijinkai Hospital

    Hokkaido, 006-8555

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto Kuramaguchi Medical Center

    Kyoto, 603-8151

  • Shinshu University Hospital

    Matsumoto, 390 8621

  • Matsuyama Red Cross Hospital

    Matsuyama, 790-8524

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Japanese Red Cross Medical Center

    Shibuya City, 150-8935

  • Tokushima University Hospital

    Tokushima, 770-8503

Other trials in Japan

France11 sites

  • CHU Dijon

    Dijon, 21000

  • Hopital Claude Huriez

    Lille, 59037

  • CHU de Limoges - Fédération Hépatologie

    Limoges, 87000

  • Institut Paoli Calmettes

    Marseille, 13273

  • Chu Hotel Dieu

    Nantes, 44035

  • Hopital Saint Louis

    Paris, 75475

  • Centre hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • CHU De Poitiers

    Poitiers, 86000

  • CHU Rangueil

    Toulouse, 31400

  • CHU Bretonneau

    Tours, 37044

  • CHU de Nancy_ Hopital Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain10 sites

  • Inst. Cat. D'Oncologia-Badalona

    Badalona, 08916

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Clinica Univ. de Navarra

    Pamplona, 31008

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

  • Hosp. Univ. de Canarias

    San Cristóbal de La Laguna, 38320

  • Hosp. Univ. Dr. Peset

    Valencia, 46017

Other trials in Spain

Brazil8 sites

  • Hospital das Clinicas de Porto Alegre

    Porto Alegre, 90035-903

  • Sociedade Pernambucana de Combate ao Cancer

    Recife, 50040-000

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

    Rio de Janeiro, 22775 001

  • Hospital Sao Rafael

    Salvador, 41253 190

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

    São José do Rio Preto, 15090-000

  • Clinica Sao Germano

    São Paulo, 01455 010

  • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

    São Paulo, 04039-004

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-010

Other trials in Brazil

Germany7 sites

  • Charite Campus Benjamin Franklin

    Berlin, 12203

  • Heinrich-Heine-Universität Düsseldorf

    Düsseldorf, 40225

  • Universitatsklinikum Essen

    Essen, 45122

  • HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH

    Hamburg, 22767

  • Universitaetsklinikum Heidelberg Medizinische Klinik V

    Heidelberg, 69120

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

    Tübingen, 72076

  • Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii

    Würzburg, 97080

Other trials in Germany

Canada6 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Alberta Health Services

    Edmonton, Alberta, T6G 1Z2

  • London Health Sciences Center

    London, Ontario, N6A 5W9

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • University Health Network UHN Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Italy6 sites

  • Policlinico di Bari

    Bari, 70124

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

    Bologna, 40138

  • Casa di Cura La Maddalena

    Palermo, 90146

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

    Pavia, 27100

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

    Roma, 00161

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

    Torino, 10126

Other trials in Italy

Turkey (Türkiye)6 sites

  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

    Ankara, 06590

  • Akdeniz University Medical Faculty

    Antalya, 7059

  • Ondokuz Mayis Universitesi Tip Fakultesiy

    Atakum, 55270

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34093

  • Dokuz Eylul Universitesi Tip Fakultesi

    Izmir, 35340

  • Erciyes University Medical Faculty

    Talas, 38039

Other trials in Turkey (Türkiye)

China5 sites

  • Peking University First Hospital

    Beijing, 100034

  • Peking University People s Hospital

    Beijing, 100044

  • First affiliated Hospital of Zhejiang University

    Hangzhou, 310020

  • Ruijin Hospital Shanghai Jiao Tong University

    Shanghai, 200025

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

Other trials in China

Israel5 sites

  • Carmel Hospital

    Haifa, 34362

  • Hadassah Medical Center

    Jerusalem, 91120

  • Sheba Medical Center

    Ramat Gan, 52621

  • Sourasky Medical Center

    Tel Aviv, 6423906

  • Assaf Ha'Rofeh Medical Center

    Ẕerifin, 70300

Other trials in Israel

Netherlands5 sites

  • UMCG

    Groningen, 9713 GZ

  • Erasmus MC

    Rotterdam, 3015 CN

  • Haga ziekenhuis

    The Hague, 2545 AA

  • UMC Utrecht

    Utrecht, 3584 CX

  • Maxima Medisch Centrum

    Veldhoven, 5504 DB

Other trials in Netherlands

South Korea5 sites

  • Pusan National University Hospital

    Busan, 49241

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Australia4 sites

  • Box Hill Hospital

    Box Hill, 3128

  • Sir Charles Gairdner Hospital

    Nedlands, 6009

  • Westmead Hospital

    Westmead, 2145

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Belgium4 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • UZ Gent

    Ghent, 9000

  • Az Groeninge

    Kortrijk, 8500

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

Other trials in Belgium

Denmark3 sites

  • Aarhus University Hospital

    Aarhus N, DK-8200

  • Dep. of Hematology, Rigshospitalet

    Copenhagen, 2400

  • Odense Universitets Hospital

    Odense, 5000

Other trials in Denmark

Hungary3 sites

  • Semmelweis Egyetem I.Belgyogyaszati Klinika

    Budapest, 1083

  • Semmelweis Egyetem I.Belgyogyaszati Klinika

    Budapest, 1088

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

    Budapest, 1097

Other trials in Hungary

Poland3 sites

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500

  • SKPP UM w Poznaniu

    Poznan, 60-569

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02 776

Other trials in Poland

Greece2 sites

  • Alexandra General Hospital of Athens

    Athens, 11528

  • University General Hospital of Rio

    Pátrai, 26500

Other trials in Greece

Mexico2 sites

  • Centro de Investigación Farmacéutica Especializada

    Guadalajara, 44160

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

Other trials in Mexico

Sweden2 sites

  • South Elvsborg Hospital

    Borås, 501 82

  • Skanes universitetssjukhus

    Lund, 221 85

Other trials in Sweden

United Kingdom2 sites

  • University Hospitals Birmingham NHS Trust,

    Birmingham, B15 2TH

  • University College Hospital

    London, NW1 2PG

Other trials in United Kingdom

About this study

Official title: 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

The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

Read the detailed description

Participant involved in study for approx. 8 years duration includes Screening Phase (complete clinical evaluation will be done), Treatment Phase (monitoring of adverse events (AEs), laboratory abnormalities and clinical response), Post-Treatment Observation Phase (disease evaluations will be done) and a Long-term Follow-up Phase (Subsequent anticancer treatment, response to subsequent treatment, date of progression and survival status will be obtained every 16 weeks).The primary hypothesis is that daratumumab in combination with CyBorD will improve the overall complete hematological response rate compared to CyBorD alone in AL amyloidosis participants. Safety will be assessed by AEs, laboratory test results, electrocardiogram, vital sign measurements, physical examination, and Eastern Cooperative Oncology Group (ECOG) performance status.

Conditions
Amyloidosis
Being tested
Cyclophosphamide, Bortezomib, Dexamethasone, 40 mg, Daratumumab
Medical subject headings
Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    Participants will receive 300 mg/m^2 of cyclophosphamide as an oral or IV dose.

  • BortezomibDrug

    Participants will receive 1.3 mg/m^2 of bortezomib as an subcutaneous (SC) injection.

  • Dexamethasone, 40 mgDrug

    Participants of CyBorD alone arm will receive 40 mg dexamethasone orally or IV dose. Participants of CyBorD plus daratumumab arm will receive dexamethasone 20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing to make a total of 40 mg.

  • DaratumumabDrug

    Participants will receive 1800 mg of daratumumab subcutaneously.

Study groups in NCT03201965
Study groupRoleWhat they receive
CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)Active comparatorParticipants will receive dexamethasone (40 milligrams [mg] orally or intravenous [IV] dose), followed by cyclophosphamide (300 milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.
Receives: Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone, 40 mg
CyBorD plus DaratumumabExperimentalParticipants will receive dexamethasone (20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.
Receives: Drug: Daratumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Overall Complete Hematologic Response (CHR)

    Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. CHR: normalization of free light chain levels and ratio, negative serum, and urine immunofixation. If involved free light chain (iFLC) is less than (<) upper limit of normal (ULN) and serum and urine Immunofixation electrophoresis (IFE) are negative, then neither a normal uninvolved free light chain (uFLC) level nor a normal free light chain (FLC) ratio are required for complete response (CR).

    Measured: Up to 2.4 years

Secondary outcomes (16)

  1. Major Organ Deterioration Progression-Free Survival (MOD-PFS)

    MOD-PFS was defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurred first. Per international amyloidosis consensus criteria (IACC), hematologic progression was defined as satisfying any one of the following criteria: 1) From CHR, abnormal free light chain ratio (light chain must be double and >ULN); 2) From CHR/VGPR/PR, 50 percent (%) increase in serum M-protein to >0.5 grams per deciliter (g/dL) or 50% increase in urine M-protein to 200 milligrams (mg)/day; 3) free light chain increase of 50% to 100 milligrams (mg)/Liter (L).

    Measured: From date of first randomization (Day -3) upto 6.5 years

  2. Overall Survival (OS)

    Overall survival (OS) was measured from the date of randomization to the date of the participant's death.

    Measured: From date of first randomization (Day -3) up to 7.1 years

  3. Organ Response Rate (OrRR) at 6 Months: Cardiac Response

    The Organ Response Rate (OrRR) for heart was defined as the percentage of participants with baseline involvement of the heart who achieved a confirmed organ response in the heart. Cardiac response was defined as as a decrease of >30% in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and greater than (>)300 nanogram/Litre (ng/L).

    Measured: Month 6

  4. Organ Response Rate (OrRR) at 6 Months: Renal Response

    The OrRR for kidney was defined as the percentage of participants with baseline involvement of the kidney who achieved a confirmed renal response in the kidney. Renal response was defined as more than equal to (≥) 30% decrease in proteinuria or proteinuria decreased to <0.5 grams (g)/24 hours in the absence of renal progression.

    Measured: Month 6

  5. Organ Response Rate (OrRR) at 6 Months: Liver Response

    The OrRR for liver was defined as the percentage of participants with baseline involvement of the liver who achieved a confirmed liver response in the liver. Liver response was defined as 50% decrease in abnormal alkaline phosphatase value.

    Measured: Month 6

  6. Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months

    CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. CHR: normalization of free light chain levels and ratio, negative serum, and urine immunofixation. If involved free light chain is < ULN and serum and urine IFE are negative, then neither a normal uninvolved free light chain (uFLC) level nor a normal free light chain (FLC) ratio are required for Complete Response (CR).

    Measured: Month 6

  7. Time to Complete Hematologic Response (CHR)

    Time to CHR was defined as time between the date of randomization and first efficacy evaluation at which the participant has met all criteria for hematologic CR. CHR was primarily defined by negative immunofixation results and normalized free light chain (FLC) parameters.

    Measured: From date of first randomization (Day -3) up to 6.5 years

  8. Time to Cardiac Response

    Time to cardiac response was defined as the time between the date of randomization and the first efficacy evaluation at which the participant had cardiac response.

    Measured: From date of first randomization (Day -3) up to 6.5 years

  9. Time to Liver Response

    Time to liver response was defined as the time between the date of randomization and the first efficacy evaluation at which the participant had liver response.

    Measured: From date of first randomization (Day -3) up to 6.5 years

  10. Time to Renal Response

    Time to renal response was defined as the time between the date of randomization and the first efficacy evaluation at which the participant had renal response.

    Measured: From date of first randomization (Day -3) up to 6.5 years

  11. Time to Subsequent Non-cross Resistant Anti-plasma Cell Therapy

    Time to subsequent non-cross resistant anti-plasma cell therapy was defined as the time from the date of randomization to the start date of subsequent non-cross resistant, anti-plasma cell therapy.

    Measured: From date of first randomization (Day -3) up to 6.5 years

  12. Duration of Complete Hematologic Response (CHR)

    Duration of CHR was defined as the time between the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive diseased. CHR was primarily defined by negative immunofixation results and normalized FLC parameters.

    Measured: From date of first randomization (Day -3) up to 6.5 years

  13. Hematologic Very Good Partial Response (VGPR) or Better Rate

    Hematologic VGPR or Better Rate was defined as percentage of participants who achieved hematologic Complete response (CR) or VGPR. VGPR was defined as the difference between involved iFLC and uFLC after treatment for baseline difference between iFLC and uFLC (dFLC) >50 milligrams per liter (mg/L): Reduction in the dFLC <40 mg/L. For Baseline dFLC < 50 mg/L: more than (>) 90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. CR was negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5% PCs in bone marrow.

    Measured: From date of first randomization (Day -3) up to 6.5 years

  14. Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue

    The EORTC-QLQ-C30 a 30-question tool was used to assess the overall quality of life (QoL) in cancer patients. It included 30 items resulting in 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 Global health status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores were transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms.

    Measured: Baseline (Day -28), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96

  15. Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)

    The SF-36 Health Survey was a generic measure of health status. The SF-36 consisted of 36 questions that yield an eight-scale (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) profile of functional health and well-being, as well as 2 physical and mental health summary measures and a preference-based health utility index. The physical component summary (PCS), the mental component summary (MCS), and the 8 domain scores range from zero (0) to 100, with higher scores representing higher level of functioning.

    Measured: Baseline (Day -28), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96

  16. Change From Baseline in EORTC QLQ-C30 Global Health Status Score

    The EORTC-QLQ-C30 a 30-question tool was used to assess the overall QoL in cancer patients. It included 30 items resulting in 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 GHS scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores were transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms.

    Measured: Baseline (Day -28), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start5 Oct 2017
  3. Primary completion14 Feb 2020
  4. Study completion19 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03201965
Sponsor's protocol ID
CR108193
Other IDs
54767414AMY3001, 2016-001737-27, 2024-511967-26-00, 2016
Status last verified
Nov 2025
First submitted
27 Jun 2017
Last updated
26 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kastritis E, Palladini G, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Sanchorawala V, Mollee P, Lu J, Schonland SO, Gatt ME, Suzuki K, Kim K, Cibeira MT, Bhutani M, Beksac M, Libby EN, Valent J, Hungria V, Rosenzweig MA, Bumma N, Huart A, Dimopoulos MA, Bhutani D, Waxman A, Goodman S, Zonder JA, Lam S, Song KW, Hansen T, Manier S, Roeloffzen WWH, Jamroziak K, Kwok F, Shimazaki C, Kim JS, Crusoe EQ, Tran N, Wang J, Chen Y, Vasey SY, Schecter JM, Vermeulen J, Comenzo R, Merlini G. Daratumumab-Bortezomib-Cyclophosphamide-Dexamethasone in Newly Diagnosed Amyloidosis: ANDROMEDA Final Survival Analysis. Blood. 2026 May 12:blood.2025032099. doi: 10.1182/blood.2025032099. Online ahead of print.

    PubMed 42118698

  • Suzuki K, Wechalekar AD, Kim K, Shimazaki C, Kim JS, Ikezoe T, Min CK, Zhou F, Cai Z, Chen X, Iida S, Katoh N, Fujisaki T, Shin HJ, Tran N, Qin X, Vasey SY, Tromp B, Weiss BM, Comenzo RL, Kastritis E, Lu J. Daratumumab plus bortezomib, cyclophosphamide, and dexamethasone in Asian patients with newly diagnosed AL amyloidosis: subgroup analysis of ANDROMEDA. Ann Hematol. 2023 Apr;102(4):863-876. doi: 10.1007/s00277-023-05090-z. Epub 2023 Mar 2.

    PubMed 36862168

  • Minnema MC, Dispenzieri A, Merlini G, Comenzo RL, Kastritis E, Wechalekar AD, Grogan M, Witteles R, Ruberg FL, Maurer MS, Tran N, Qin X, Vasey SY, Weiss BM, Vermeulen J, Jaccard A. Outcomes by Cardiac Stage in Patients With Newly Diagnosed AL Amyloidosis: Phase 3 ANDROMEDA Trial. JACC CardioOncol. 2022 Nov 15;4(4):474-487. doi: 10.1016/j.jaccao.2022.08.011. eCollection 2022 Nov.

    PubMed 36444227

  • Kastritis E, Palladini G, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Sanchorawala V, Gibbs S, Mollee P, Venner CP, Lu J, Schonland S, Gatt ME, Suzuki K, Kim K, Cibeira MT, Beksac M, Libby E, Valent J, Hungria V, Wong SW, Rosenzweig M, Bumma N, Huart A, Dimopoulos MA, Bhutani D, Waxman AJ, Goodman SA, Zonder JA, Lam S, Song K, Hansen T, Manier S, Roeloffzen W, Jamroziak K, Kwok F, Shimazaki C, Kim JS, Crusoe E, Ahmadi T, Tran N, Qin X, Vasey SY, Tromp B, Schecter JM, Weiss BM, Zhuang SH, Vermeulen J, Merlini G, Comenzo RL; ANDROMEDA Trial Investigators. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis. N Engl J Med. 2021 Jul 1;385(1):46-58. doi: 10.1056/NEJMoa2028631.

    PubMed 34192431

  • Palladini G, Kastritis E, Maurer MS, Zonder J, Minnema MC, Wechalekar AD, Jaccard A, Lee HC, Bumma N, Kaufman JL, Medvedova E, Kovacsovics T, Rosenzweig M, Sanchorawala V, Qin X, Vasey SY, Weiss BM, Vermeulen J, Merlini G, Comenzo RL. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood. 2020 Jul 2;136(1):71-80. doi: 10.1182/blood.2019004460.

    PubMed 32244252

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclophosphamide, Bortezomib and Dexamethasone, 40 mg in people with Amyloidosis, run by Janssen Research & Development, LLC at 140 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Japan, France, Spain, Brazil and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Overall Complete Hematologic Response (CHR) (time frame: Up to 2.4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03201965, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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