AL Amyloidosis Clinical 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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

AL Amyloidosis

Phase:

Phase 3

Estimated Enrollment:

416

Study ID:

NCT03201965

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 140 Locations for this study

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Mayo Clinic Arizona
Phoenix Arizona, 85054, United States
City of Hope
Duarte California, 91010, United States
University of California San Francisco
San Francisco California, 94143, United States
Stanford University
Stanford California, 94305, United States
University of Colorado
Aurora Colorado, 80045, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Winship Cancer Institute Emory University
Atlanta Georgia, 30322, United States
University of Maryland
Baltimore Maryland, 21201, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Boston University Medical Center
Boston Massachusetts, 02118, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Columbia University Medical Center
New York New York, 10032, United States
Weill Cornell Medical College
New York New York, 10065, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Wake Forest University Health Sciences - Cardiovascular Medicine
Winston-Salem North Carolina, 27157, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
The Ohio State University
Columbus Ohio, 43210, United States
Oregon Health And Science University
Portland Oregon, 97239, United States
University of Pennsylvania Medical Center
Philadelphia Pennsylvania, 19104, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Box Hill Hospital
Box Hill , 3128, Australia
Sir Charles Gairdner Hospital
Nedlands , 6009, Australia
Westmead Hospital
Westmead , 2145, Australia
Princess Alexandra Hospital
Woolloongabba , 4102, Australia
Institut Jules Bordet
Anderlecht , 1070, Belgium
UZ Gent
Gent , 9000, Belgium
Az Groeninge
Kortrijk , 8500, Belgium
Universitair Ziekenhuis Leuven
Leuven , 3000, Belgium
Hospital das Clinicas de Porto Alegre
Porto Alegre , 90035, Brazil
Sociedade Pernambucana de Combate ao Cancer
Recife , 50040, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22775, Brazil
Hospital Sao Rafael
Salvador , 41253, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
Sao Jose do Rio Preto , 15090, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
Sao Paulo , 04039, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo , 05403, Brazil
Alberta Health Services
Calgary Alberta, T2N 4, Canada
Alberta Health Services
Edmonton Alberta, T6G 1, Canada
Vancouver General Hospital
Vancouver British Columbia, V5Z 1, Canada
London Health Sciences Center
London Ontario, N6A 5, Canada
University Health Network UHN Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
Peking University First Hospital
Beijing , 10003, China
Peking University People s Hospital
Beijing , 10004, China
First affiliated Hospital of Zhejiang University
Hangzhou , 31002, China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai , 20002, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , 32500, China
Aarhus University Hospital
Aarhus C , 8000, Denmark
Dep. of Hematology, Rigshospitalet
Copenhagen , 2400, Denmark
Odense Universitets Hospital
Odense , 5000, Denmark
CHU Dijon
Dijon , 21000, France
Hopital Claude Huriez
Lille cedex , 59037, France
CHU de Limoges - Fédération Hépatologie
Limoges , 87000, France
Institut Paoli Calmettes
Marseille , 13273, France
Chu Hotel Dieu
Nantes cedex 01 , 44035, France
Hopital Saint Louis
PARIS cedex 10 , 75475, France
Centre hospitalier Lyon-Sud
Pierre - Bénite cedex , 69495, France
CHU De Poitiers
Poitiers , 86000, France
CHU Rangueil
Toulouse , 31400, France
CHU Bretonneau
Tours cedex , 37044, France
CHU de Nancy_ Hopital Brabois
Vandoeuvre les Nancy , 54511, France
Charite Campus Benjamin Franklin
Berlin , 12203, Germany
Heinrich-Heine-Universität Düsseldorf
Düsseldorf , 40225, Germany
Universitatsklinikum Essen
Essen , 45122, Germany
HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH
Hamburg , 22767, Germany
Universitaetsklinikum Heidelberg Medizinische Klinik V
Heidelberg , 69120, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen , 72076, Germany
Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
Würzburg , 97080, Germany
Alexandra General Hospital of Athens
Athens , 11528, Greece
University General Hospital of Rio
Patra , 26500, Greece
Semmelweis Egyetem I.Belgyogyaszati Klinika
Budapest , 1083, Hungary
Semmelweis Egyetem I.Belgyogyaszati Klinika
Budapest , 1088, Hungary
Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
Budapest , 1097, Hungary
Carmel Hospital
Haifa , 34362, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Sheba Medical Center
Ramat-Gan , 52621, Israel
Sourasky Medical Center
Tel-Aviv , 64239, Israel
Assaf Ha'Rofeh Medical Center
Zerifin , 70300, Israel
Policlinico di Bari
Bari , 70124, Italy
Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
Bologna , 40138, Italy
Casa di Cura La Maddalena
Palermo , 90146, Italy
Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Dipartimento Di Biotecnologie Cellulari Ed Ematologia-Università ''La Sapienza'',Policlinico Umberto I
Roma , 00161, Italy
A.O.U. Città della Salute e della Scienza
Torino , 10126, Italy
Fukushima Medical University Hospital
Fukushima , 960-1, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima , 730-8, Japan
Teine Keijinkai Hospital
Hokkaido , 006-8, Japan
Kanazawa University Hospital
Kanazawa , 920-8, Japan
Kumamoto University Hospital
Kumamoto-City , 860-8, Japan
Kyoto Kuramaguchi Medical Center
Kyoto , 603-8, Japan
Shinshu University Hospital
Matsumoto , 390-8, Japan
Matsuyama Red Cross Hospital
Matsuyama , 790-8, Japan
Nagoya City University Hospital
Nagoya , 467 8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
Japanese Red Cross Medical Center
Shibuya , 150-8, Japan
Tokushima University Hospital
Tokushima , 770-8, Japan
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
Centro de Investigación Farmacéutica Especializada
Guadalajara , 44160, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey , 64460, Mexico
Haga ziekenhuis
Den Haag , 2545 , Netherlands
UMCG
Groningen , 9713 , Netherlands
Erasmus MC
Rotterdam , 3015 , Netherlands
UMC Utrecht
Utrecht , 3584 , Netherlands
Maxima Medisch Centrum
Veldhoven , 5504 , Netherlands
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów , 41-50, Poland
SKPP UM w Poznaniu
Poznan , 60-56, Poland
Instytut Hematologii i Transfuzjologii
Warszawa , 02-77, Poland
Inst. Cat. D'Oncologia-Badalona
Badalona , 08916, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Clinic de Barcelona
Barcelona , 08036, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. de Canarias
San Cristóbal de La Laguna , 38320, Spain
Hosp. Univ. Dr. Peset
Valencia , 46017, Spain
South Elvsborg Hospital
Boras , 501 8, Sweden
Skanes universitetssjukhus
Lund , 221 8, Sweden
Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
Ankara , 06590, Turkey
Akdeniz University Medical Faculty
Antalya , 7059, Turkey
Ondokuz Mayis Universitesi Tip Fakultesi
Atakum , 55270, Turkey
Istanbul University Istanbul Medical Faculty
Istanbul , 34093, Turkey
Dokuz Eylul Universitesi Tip Fakultesi
Izmir , 35340, Turkey
Erciyes University Medical Faculty
Talas , 38039, Turkey
University Hospitals Birmingham NHS Trust,
Birmingham , B15 2, United Kingdom
University College Hospital
London , NW1 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

AL Amyloidosis

Phase:

Phase 3

Estimated Enrollment:

416

Study ID:

NCT03201965

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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