search
Back to results

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

Primary Purpose

Amyloidosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cyclophosphamide
Bortezomib
Dexamethasone, 40 mg
Daratumumab
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Arizona
  • City of Hope
  • University of California, San Francisco
  • Stanford University
  • University of Colorado
  • Colorado Blood Cancer Institute
  • Mayo Clinic
  • Winship Cancer Institute Emory University
  • University of Maryland
  • Tufts Medical Center
  • Boston University Medical Center
  • Dana-Farber Cancer Institute
  • Barbara Ann Karmanos Cancer Institute
  • Mayo Clinic Rochester
  • Washington University School of Medicine
  • Columbia University Medical Center
  • Weill Cornell Medical College
  • University of Rochester Medical Center
  • Levine Cancer Institute
  • Wake Forest University Health Sciences - Cardiovascular Medicine
  • Cleveland Clinic
  • The Ohio State University
  • Oregon Health & Science University
  • University of Pennsylvania Medical Center
  • Sarah Cannon Research Institute
  • Vanderbilt University Medical Center
  • University of Texas, MD Anderson Cancer Center
  • Huntsman Cancer Institute
  • Seattle Cancer Care Alliance
  • Box Hill Hospital
  • Sir Charles Gairdner Hospital
  • Westmead Hospital
  • Princess Alexandra Hospital
  • Institut Jules Bordet
  • UZ Gent
  • Az Groeninge
  • Universitair Ziekenhuis Leuven
  • Hospital das Clinicas de Porto Alegre
  • Sociedade Pernambucana de Combate ao Cancer
  • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Hospital Sao Rafael
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
  • Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
  • Clinica Sao Germano
  • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • Alberta Health Services
  • Alberta Health Services
  • Vancouver General Hospital
  • London Health Sciences Center
  • University Health Network (UHN) Princess Margaret Cancer Centre
  • McGill University Health Centre
  • Peking University First Hospital
  • Peking University People's Hospital
  • First affiliated Hospital of Zhejiang University
  • Ruijin Hospital, Shanghai Jiao Tong University
  • The First Affiliated Hospital of Wenzhou Medical University
  • Aarhus University Hospital
  • Dep. of Hematology, Rigshospitalet
  • Odense Universitets Hospital
  • CHU Dijon
  • Hopital Claude Huriez
  • CHU de Limoges - Fédération Hépatologie
  • Institut Paoli Calmettes
  • Chu Hotel Dieu
  • Hopital Saint-Louis
  • Centre hospitalier Lyon-Sud
  • CHU De Poitiers
  • CHU Rangueil
  • CHU Bretonneau
  • CHU de Nancy_ Hopital Brabois
  • Charite Campus Benjamin Franklin
  • Heinrich-Heine-Universität Düsseldorf
  • Universitatsklinikum Essen
  • HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH
  • Universitaetsklinikum Heidelberg Medizinische Klinik V
  • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
  • Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
  • Alexandra General Hospital of Athens
  • University General Hospital of Rio
  • Semmelweis Egyetem I.Belgyogyaszati Klinika
  • Semmelweis Egyetem I.Belgyogyaszati Klinika
  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
  • Carmel Hospital
  • Hadassah Medical Center
  • Sheba Medical Center
  • Sourasky Medical Center
  • Assaf Ha'Rofeh Medical Center
  • Policlinico di Bari
  • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
  • Casa di Cura La Maddalena
  • Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo
  • Dipartimento Di Biotecnologie Cellulari Ed Ematologia-Università ''La Sapienza'',Policlinico Umberto I
  • A.O.U. Città della Salute e della Scienza
  • Fukushima Medical University Hospital
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
  • Teine Keijinkai Hospital
  • Kanazawa University Hospital
  • Kumamoto University Hospital
  • Kyoto Kuramaguchi Medical Center
  • Shinshu University Hospital
  • Matsuyama Red Cross Hospital
  • Nagoya City University Hospital
  • National Hospital Organization Okayama Medical Center
  • Japanese Red Cross Medical Center
  • Tokushima University Hospital
  • Pusan National University Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Samsung Medical Center
  • The Catholic University of Korea Seoul St. Mary's Hospital
  • Centro de Investigación Farmacéutica Especializada
  • Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
  • Haga ziekenhuis
  • UMCG
  • Erasmus MC
  • UMC Utrecht
  • Maxima Medisch Centrum
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
  • SKPP UM w Poznaniu
  • Instytut Hematologii i Transfuzjologii
  • Inst. Cat. D'Oncologia-Badalona
  • Hosp. Univ. Vall D Hebron
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. Ramon Y Cajal
  • Hosp. Univ. Fund. Jimenez Diaz
  • Hosp. Univ. 12 de Octubre
  • Clinica Univ. de Navarra
  • Hosp. Clinico Univ. de Salamanca
  • Hosp. Univ. de Canarias
  • Hosp. Univ. Dr. Peset
  • South Elvsborg Hospital
  • Skanes universitetssjukhus
  • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
  • Akdeniz University Medical Faculty
  • Ondokuz Mayis Universitesi Tip Fakultesi
  • Istanbul University Istanbul Medical Faculty
  • Dokuz Eylul Universitesi Tip Fakultesi
  • Erciyes University Medical Faculty
  • University Hospitals Birmingham NHS Trust,
  • University College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)

CyBorD plus Daratumumab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
June 27, 2017
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT03201965
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
August 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyloidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CyBorD plus Daratumumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Participants will receive 300 mg/m^2 of cyclophosphamide as an oral or IV dose.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Participants will receive 1.3 mg/m^2 of bortezomib as an subcutaneous (SC) injection.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone, 40 mg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Daratumumab
Intervention Description
Participants will receive 1800 mg of daratumumab subcutaneously.
Primary Outcome Measure Information:
Title
Percentage of Participants With Overall Complete Hematologic Response (CHR)
Description
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).
Time Frame
Up to 2.4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Winship Cancer Institute Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5418
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Wake Forest University Health Sciences - Cardiovascular Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Box Hill Hospital
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Institut Jules Bordet
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Az Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital das Clinicas de Porto Alegre
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Sociedade Pernambucana de Combate ao Cancer
City
Recife
ZIP/Postal Code
50040-000
Country
Brazil
Facility Name
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
City
Rio de Janeiro
ZIP/Postal Code
22775-001
Country
Brazil
Facility Name
Hospital Sao Rafael
City
Salvador
ZIP/Postal Code
41253-190
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE
City
Sao Paulo
ZIP/Postal Code
04039-004
Country
Brazil
Facility Name
Clinica Sao Germano
City
São Paulo
ZIP/Postal Code
01455-010
Country
Brazil
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina Da USP
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Alberta Health Services
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
University Health Network (UHN) Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
First affiliated Hospital of Zhejiang University
City
Hangzhou
ZIP/Postal Code
310020
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Dep. of Hematology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Odense Universitets Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Claude Huriez
City
Lille cedex
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Limoges - Fédération Hépatologie
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Chu Hotel Dieu
City
Nantes cedex 01
ZIP/Postal Code
44035
Country
France
Facility Name
Hopital Saint-Louis
City
PARIS cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Centre hospitalier Lyon-Sud
City
Pierre - Bénite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
CHU De Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31400
Country
France
Facility Name
CHU Bretonneau
City
Tours cedex
ZIP/Postal Code
37044
Country
France
Facility Name
CHU de Nancy_ Hopital Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Charite Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Heinrich-Heine-Universität Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg Medizinische Klinik V
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Alexandra General Hospital of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
University General Hospital of Rio
City
Patra
ZIP/Postal Code
26500
Country
Greece
Facility Name
Semmelweis Egyetem I.Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Semmelweis Egyetem I.Belgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Facility Name
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Carmel Hospital
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat-Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assaf Ha'Rofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Casa di Cura La Maddalena
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Dipartimento Di Biotecnologie Cellulari Ed Ematologia-Università ''La Sapienza'',Policlinico Umberto I
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O.U. Città della Salute e della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Teine Keijinkai Hospital
City
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto-City
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto Kuramaguchi Medical Center
City
Kyoto
ZIP/Postal Code
603-8151
Country
Japan
Facility Name
Shinshu University Hospital
City
Matsumoto
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Matsuyama Red Cross Hospital
City
Matsuyama
ZIP/Postal Code
790-8524
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
National Hospital Organization Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Japanese Red Cross Medical Center
City
Shibuya
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Centro de Investigación Farmacéutica Especializada
City
Guadalajara
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Haga ziekenhuis
City
Den Haag
ZIP/Postal Code
2545 AA
Country
Netherlands
Facility Name
UMCG
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Veldhoven
ZIP/Postal Code
5504 DB
Country
Netherlands
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Facility Name
SKPP UM w Poznaniu
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Inst. Cat. D'Oncologia-Badalona
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Clinica Univ. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hosp. Univ. de Canarias
City
San Cristóbal de La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hosp. Univ. Dr. Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
South Elvsborg Hospital
City
Boras
ZIP/Postal Code
501 82
Country
Sweden
Facility Name
Skanes universitetssjukhus
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
7059
Country
Turkey
Facility Name
Ondokuz Mayis Universitesi Tip Fakultesi
City
Atakum
ZIP/Postal Code
55270
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Dokuz Eylul Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Erciyes University Medical Faculty
City
Talas
ZIP/Postal Code
38039
Country
Turkey
Facility Name
University Hospitals Birmingham NHS Trust,
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34192431
Citation
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.
Results Reference
derived
PubMed Identifier
32244252
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs