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

November 12, 2025 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
416

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Box Hill, Australia, 3128
        • Box Hill Hospital
      • Nedlands, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Westmead, Australia, 2145
        • Westmead Hospital
      • Woolloongabba, Australia, 4102
        • Princess Alexandra Hospital
  • Belgium
      • Anderlecht, Belgium, 1070
        • Institut Jules Bordet
      • Ghent, Belgium, 9000
        • UZ Gent
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven
  • Brazil
      • Porto Alegre, Brazil, 90035-903
        • Hospital das Clinicas de Porto Alegre
      • Recife, Brazil, 50040-000
        • Sociedade Pernambucana de Combate ao Cancer
      • Rio de Janeiro, Brazil, 22775 001
        • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
      • Salvador, Brazil, 41253 190
        • Hospital Sao Rafael
      • São José do Rio Preto, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
      • São Paulo, Brazil, 05403-010
        • Hospital das Clinicas da Faculdade de Medicina da USP
      • São Paulo, Brazil, 01455 010
        • Clinica Sao Germano
      • São Paulo, Brazil, 04039-004
        • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J E Child Comprehensive Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Alberta Health Services
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Center
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network UHN Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
  • China
      • Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, China, 100044
        • Peking University People s Hospital
      • Hangzhou, China, 310020
        • First Affiliated Hospital of Zhejiang University
      • Shanghai, China, 200025
        • Ruijin Hospital Shanghai Jiao Tong University
      • Wenzhou, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
  • Denmark
      • Aarhus N, Denmark, DK-8200
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2400
        • Dep. of Hematology, Rigshospitalet
      • Odense, Denmark, 5000
        • Odense Universitets Hospital
  • France
      • Dijon, France, 21000
        • CHU Dijon
      • Lille, France, 59037
        • Hopital Claude Huriez
      • Limoges, France, 87000
        • CHU de Limoges - Fédération Hépatologie
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Nantes, France, 44035
        • Chu Hotel Dieu
      • Paris, France, 75475
        • Hopital Saint Louis
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon-Sud
      • Poitiers, France, 86000
        • Chu de Poitiers
      • Toulouse, France, 31400
        • CHU Rangueil
      • Tours, France, 37044
        • Chu Bretonneau
      • Vandœuvre-lès-Nancy, France, 54511
        • CHU de Nancy_ Hopital Brabois
  • Germany
      • Berlin, Germany, 12203
        • Charite Campus Benjamin Franklin
      • Düsseldorf, Germany, 40225
        • Heinrich-Heine-Universität Düsseldorf
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Hamburg, Germany, 22767
        • HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg Medizinische Klinik V
      • Tübingen, Germany, 72076
        • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
  • Greece
      • Athens, Greece, 11528
        • Alexandra General Hospital of Athens
      • Pátrai, Greece, 26500
        • University General Hospital of Rio
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem I.Belgyogyaszati Klinika
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem I.Belgyogyaszati Klinika
      • Budapest, Hungary, 1097
        • Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
  • Israel
      • Haifa, Israel, 34362
        • Carmel Hospital
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Ramat Gan, Israel, 52621
        • Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center
      • Ẕerifin, Israel, 70300
        • Assaf Ha'Rofeh Medical Center
  • Italy
      • Bari, Italy, 70124
        • Policlinico di Bari
      • Bologna, Italy, 40138
        • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
      • Palermo, Italy, 90146
        • Casa di Cura La Maddalena
      • Pavia, Italy, 27100
        • Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo
      • Roma, Italy, 00161
        • Dipartimento Di Biotecnologie Cellulari Ed Ematologia-Università ''La Sapienza'',Policlinico Umberto I
      • Torino, Italy, 10126
        • A.O.U. Città della Salute e della Scienza
  • Japan
      • Fukushima, Japan, 960 1295
        • Fukushima Medical University Hospital
      • Hiroshima, Japan, 730-8619
        • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
      • Hokkaido, Japan, 006-8555
        • Teine Keijinkai Hospital
      • Kanazawa, Japan, 920 8641
        • Kanazawa University Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kyoto, Japan, 603-8151
        • Kyoto Kuramaguchi Medical Center
      • Matsumoto, Japan, 390 8621
        • Shinshu University Hospital
      • Matsuyama, Japan, 790-8524
        • Matsuyama Red Cross Hospital
      • Nagoya, Japan, 467 8602
        • Nagoya City University Hospital
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
      • Shibuya City, Japan, 150-8935
        • Japanese Red Cross Medical Center
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital
  • Mexico
      • Guadalajara, Mexico, 44160
        • Centro de Investigación Farmacéutica Especializada
      • Monterrey, Mexico, 64460
        • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • UMCG
      • Rotterdam, Netherlands, 3015 CN
        • Erasmus MC
      • The Hague, Netherlands, 2545 AA
        • Haga ziekenhuis
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht
      • Veldhoven, Netherlands, 5504 DB
        • Maxima Medisch Centrum
  • Poland
      • Chorzów, Poland, 41-500
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
      • Poznan, Poland, 60-569
        • SKPP UM w Poznaniu
      • Warsaw, Poland, 02 776
        • Instytut Hematologii i Transfuzjologii
  • South Korea
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St Marys Hospital
  • Spain
      • Badalona, Spain, 08916
        • Inst. Cat. D'Oncologia-Badalona
      • Barcelona, Spain, 08036
        • Hosp Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hosp Univ Vall D Hebron
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28034
        • Hosp. Univ. Ramon Y Cajal
      • Madrid, Spain, 28040
        • Hosp Univ Fund Jimenez Diaz
      • Pamplona, Spain, 31008
        • Clinica Univ. de Navarra
      • Salamanca, Spain, 37007
        • Hosp Clinico Univ de Salamanca
      • San Cristóbal de La Laguna, Spain, 38320
        • Hosp. Univ. de Canarias
      • Valencia, Spain, 46017
        • Hosp. Univ. Dr. Peset
  • Sweden
      • Borås, Sweden, 501 82
        • South Elvsborg Hospital
      • Lund, Sweden, 221 85
        • Skanes universitetssjukhus
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06590
        • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
      • Antalya, Turkey (Türkiye), 7059
        • Akdeniz University Medical Faculty
      • Atakum, Turkey (Türkiye), 55270
        • Ondokuz Mayis Universitesi Tip Fakultesiy
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul University Istanbul Medical Faculty
      • Izmir, Turkey (Türkiye), 35340
        • Dokuz Eylul Universitesi Tip Fakultesi
      • Talas, Turkey (Türkiye), 38039
        • Erciyes University Medical Faculty
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Trust,
      • London, United Kingdom, NW1 2PG
        • University College Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute Emory University
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston University Medical Center
      • Boston, Massachusetts, United States, 02215-5418
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences - Cardiovascular Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas, MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)
Participants 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.
Drug: Cyclophosphamide
Participants will receive 300 mg/m^2 of cyclophosphamide as an oral or IV dose.
Drug: Bortezomib
Participants will receive 1.3 mg/m^2 of bortezomib as an subcutaneous (SC) injection.
Drug: Dexamethasone, 40 mg
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.
Experimental: CyBorD plus Daratumumab
Participants 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.
Drug: Daratumumab
Participants will receive 1800 mg of daratumumab subcutaneously.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Overall Complete Hematologic Response (CHR)
Time Frame: Up to 2.4 years
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).
Up to 2.4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Organ Deterioration Progression-Free Survival (MOD-PFS)
Time Frame: From date of first randomization (Day -3) upto 6.5 years
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).
From date of first randomization (Day -3) upto 6.5 years
Overall Survival (OS)
Time Frame: From date of first randomization (Day -3) up to 7.1 years
Overall survival (OS) was measured from the date of randomization to the date of the participant's death.
From date of first randomization (Day -3) up to 7.1 years
Organ Response Rate (OrRR) at 6 Months: Cardiac Response
Time Frame: Month 6
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).
Month 6
Organ Response Rate (OrRR) at 6 Months: Renal Response
Time Frame: Month 6
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.
Month 6
Organ Response Rate (OrRR) at 6 Months: Liver Response
Time Frame: Month 6
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.
Month 6
Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months
Time Frame: Month 6
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).
Month 6
Time to Complete Hematologic Response (CHR)
Time Frame: From date of first randomization (Day -3) up to 6.5 years
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.
From date of first randomization (Day -3) up to 6.5 years
Time to Cardiac Response
Time Frame: From date of first randomization (Day -3) up to 6.5 years
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.
From date of first randomization (Day -3) up to 6.5 years
Time to Liver Response
Time Frame: From date of first randomization (Day -3) up to 6.5 years
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.
From date of first randomization (Day -3) up to 6.5 years
Time to Renal Response
Time Frame: From date of first randomization (Day -3) up to 6.5 years
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.
From date of first randomization (Day -3) up to 6.5 years
Time to Subsequent Non-cross Resistant Anti-plasma Cell Therapy
Time Frame: From date of first randomization (Day -3) up to 6.5 years
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.
From date of first randomization (Day -3) up to 6.5 years
Duration of Complete Hematologic Response (CHR)
Time Frame: From date of first randomization (Day -3) up to 6.5 years
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.
From date of first randomization (Day -3) up to 6.5 years
Hematologic Very Good Partial Response (VGPR) or Better Rate
Time Frame: From date of first randomization (Day -3) up to 6.5 years
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.
From date of first randomization (Day -3) up to 6.5 years
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Time Frame: 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
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.
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
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Time Frame: 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
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.
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
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Time Frame: 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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108193
  • 2016-001737-27 (EudraCT Number)
  • 54767414AMY3001 (Other Identifier: Janssen Research & Development, LLC)
  • 2024-511967-26-00 (Registry Identifier: EUCT number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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