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A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis (AFFIRM-AL)

Primary Purpose

Light Chain (AL) Amyloidosis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Birtamimab
Placebo
Standard of Care Chemotherapy
Sponsored by
Prothena Biosciences Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Light Chain (AL) Amyloidosis focused on measuring Light Chain (AL) Amyloidosis, Mayo Stage IV, birtamimab

Eligibility Criteria

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

Key Inclusion Criteria:

  • Aged ≥18 years and legal age of consent according to local regulations
  • Newly diagnosed and AL amyloidosis treatment-naïve with cardiac involvement
  • Confirmed diagnosis of AL amyloidosis
  • Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP ≥1800 pg/mL and Troponin-T >0.03 ng/mL and dFLC ≥18 mg/dL
  • Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly.

Key Exclusion Criteria:

  • Non-AL amyloidosis.
  • NT-proBNP >8500 pg/mL.
  • Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma
  • Subject is eligible for and plans to undergo ASCT or organ transplant during the study.
  • Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 Visit.
  • Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease.
  • ECG evidence of acute ischemia or active conduction system abnormalities
  • Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1.
  • Prior radiotherapy within 4 weeks of Month 1-Day 1.
  • Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11- 1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational treatment directed at amyloid .
  • Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy

Sites / Locations

  • St. Francis HospitalRecruiting
  • Yale Cancer CenterRecruiting
  • Smilow Cancer Hospital Care Center at TrumbullRecruiting
  • MedStar Georgetown University HospitalRecruiting
  • Cleveland Clinic FloridaRecruiting
  • Johns Hopkins UniversityRecruiting
  • Boston University School of Med.Recruiting
  • Dana-Farber Cancer InstituteRecruiting
  • University of Michigan Rogel Cancer CenterRecruiting
  • Barbara Ann Karmanos Cancer InstituteRecruiting
  • Mayo Clinic - RochesterRecruiting
  • University of Nebraska Medical CenterRecruiting
  • Hackensack University Medical CenterRecruiting
  • Roswell Park Comprehensive Cancer CenterRecruiting
  • Perlmutter Cancer Center - 38th StreetRecruiting
  • New York University Langone Hospital - Long Island
  • Duke Clinical Research InstituteRecruiting
  • Wake Forest Baptist Health - Comprehensive Cancer CenterRecruiting
  • Cleveland Clinic Main CampusRecruiting
  • The Ohio State University College of MedicineRecruiting
  • University of Tennessee Medical CenterRecruiting
  • Baylor University Medical CenterRecruiting
  • University of WashingtonRecruiting
  • Froedtert and Medical College of WisconsinRecruiting
  • SESLHD: St George HospitalRecruiting
  • Icon Cancer Centre - WesleyRecruiting
  • Icon Cancer CenterRecruiting
  • Royal Adelaide HospitalRecruiting
  • Box Hill Hospital
  • Royal Perth HospitalRecruiting
  • Paracelsus Medical UniversityRecruiting
  • Medizinische UniversitätRecruiting
  • Medizinische Universität WienRecruiting
  • AZ Sint-Jan Brugge-Oostende AVRecruiting
  • CHU UCL Namur (Site Godinne)Recruiting
  • Tom Baker Cancer CentreRecruiting
  • Royal Victoria HospitalRecruiting
  • Fakultní Nemocnice BrnoRecruiting
  • Fakultni nemocnice ostravaRecruiting
  • Všeobecná fakultní nemocnice v PrazeRecruiting
  • Odense UniversitetshospitalRecruiting
  • Hôpital BretonneauRecruiting
  • Hôpital Haut-LévêqueRecruiting
  • Hopital NeckerRecruiting
  • Pitie-Salpêtrière HospitalRecruiting
  • Hôpitaux de BraboisRecruiting
  • Hopital RangueilRecruiting
  • Hôpital Claude HuriezRecruiting
  • CHU NantesRecruiting
  • Centre Hospitalier Universitaire PoitiersRecruiting
  • CHU de BordeauxRecruiting
  • Hopital Henri Mondor, CreteilRecruiting
  • Centre Hospitalier Universitaire LimogesRecruiting
  • Hôpital Necker-Enfants MaladesRecruiting
  • Universitätsklinikum HeidelbergRecruiting
  • Uniklinik KölnRecruiting
  • University Medicine MainzRecruiting
  • Charité Campus Mitte
  • Alexandra General HospitalRecruiting
  • Theagenio Anti-Cancer Hospital of ThessalonikiRecruiting
  • University Hospital of PatrasRecruiting
  • Pécsi Tudományegyetem Klinikai Központ
  • Szent-Györgyi Albert Klinikai KözpontRecruiting
  • Debreceni Egyetem Klinikai KözpontRecruiting
  • Semmelweis Egyetem - I. sz. Belgyógyászati Klinika
  • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai IntézetRecruiting
  • Cork University Hospital
  • Cancer Clinical Trials and Research Unit, Beaumont HospitalRecruiting
  • Bnai Zion Medical CenterRecruiting
  • Rambam Medical CenterRecruiting
  • Hadassah Medical CenterRecruiting
  • Rabin Medical Center - Beilinson HospitalRecruiting
  • Samson Assuta Ashdod HospitalRecruiting
  • Barzilai Medical CenterRecruiting
  • Carmel Medical CenterRecruiting
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Di AnconaRecruiting
  • Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-MalpighiRecruiting
  • ASST Spedali CiviliRecruiting
  • Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San MarcoRecruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Azienda Ospedaliero-Universitaria PisanaRecruiting
  • Umberto I - Policlinico di RomaRecruiting
  • Kyoto Kuramaguchi Medical CenterRecruiting
  • Shinshu University HospitalRecruiting
  • Jichi medical university hospitalRecruiting
  • Tokushima University HospitalRecruiting
  • Red Cross Medical CenterRecruiting
  • Nagoya City University HospitalRecruiting
  • Fukushima Medical University HospitalRecruiting
  • Keimyung University Dongsan HospitalRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Severance HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Kosin University Gospel HospitalRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Hanyang University Seoul HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea - Seoul St. Mary's HospitalRecruiting
  • Maastricht Universitair Medisch CentrumRecruiting
  • Universitair Medisch Centrum Groningen
  • Klinika Hematologii i TransplantologiiRecruiting
  • Hospital de BragaRecruiting
  • Centro Hospitalar e Universitário de CoimbraRecruiting
  • Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa MariaRecruiting
  • Hospital Universitario Son EspasesRecruiting
  • Hospital Son LlatzerRecruiting
  • Institut Català d'Oncologia - Hospital Germans Trias i PujolRecruiting
  • University Hospital Marqués de ValdecillaRecruiting
  • Hospital Universitario Puerta de Hierro - MajadahondaRecruiting
  • Clinica Universidad de Navarra -MadridRecruiting
  • Clinica Universidad de Navarra - PamplonaRecruiting
  • Hospital Universitario de CanariasRecruiting
  • Hospital Universitari Vall d'hebronRecruiting
  • Hospital Clinic of BarcelonaRecruiting
  • Institut Català d'Oncologia - Hospital Duran i ReynalsRecruiting
  • Hospital Josep Trueta ICO GironaRecruiting
  • Hospital Ramon y CajalRecruiting
  • Complejo Asistencial Universitario de Salamanca - Hospital ClínicoRecruiting
  • Hospital Universitari i Politècnic la FeRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • National Taiwan University HospitalRecruiting
  • Kaohsiung Chang Gung Memorial HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Ankara UMFRecruiting
  • Gazi UniversityRecruiting
  • Istanbul University Cerrahpasa Medical Faculty
  • Ege Universitesi Tip FakultesiRecruiting
  • University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth HospitalRecruiting
  • The Newcastle Upon Tyne Hospitals NHS Foundation TrustRecruiting
  • Barts Health NHS TrustRecruiting
  • Univiersity College London HospitalsRecruiting
  • Manchester University NHS Foundation Trust
  • Nottingham University Hospitals NHS Trust
  • Belfast City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Birtamimab plus Standard of Care Chemotherapy

Placebo plus Standard of Care Chemotherapy

Arm Description

Intravenous administration of 24 mg/kg birtamimab every 28 days. Drug: Standard of Care Chemotherapy. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD) according to the institutional standard of care. Initiation of daratumumab at randomization allowed at the discretion of the investigator

Intravenous 0.9% Saline administration as a placebo every 28 days. Drug: Standard of Care Chemotherapy. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD) according to the institutional standard of care. Initiation of daratumumab at randomization allowed at the discretion of the investigator

Outcomes

Primary Outcome Measures

Time to all-cause mortality
Comparison of time to all-cause mortality for birtamimab and placebo control.

Secondary Outcome Measures

6MWT distance
Change from baseline to Month 9 in the 6-Minute Walk Test (6MWT) distance
Physical Component Summary (PCS) score of the Short Form-36, version 2 (SF-36v2)
The Short Form-36, version 2 (SF-36v2) is a 36-item self-administered quality-of-life (QoL) questionnaire that measures health on functional status, well-being, and overall evaluation of health. Higher SF-36 scores represent better health. The Physical Component Summary (PCS) is derived primarily from questions regarding physical functioning, physical problems, bodily pain, and general health questions

Full Information

First Posted
July 1, 2021
Last Updated
October 11, 2023
Sponsor
Prothena Biosciences Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04973137
Brief Title
A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis
Acronym
AFFIRM-AL
Official Title
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prothena Biosciences Ltd.

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
A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
Detailed Description
This is a Phase 3 multicenter, global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of birtamimab in Mayo Stage IV patients with AL amyloidosis. The primary objective is to evaluate the efficacy of birtamimab by assessing time to all-cause mortality. All patients will receive bortezomib-containing chemotherapy regimen as standard of care. Approximately 150 newly diagnosed Mayo Stage IV patients with AL amyloidosis will be enrolled and randomized in a 2:1 ratio to birtamimab or placebo. Subjects will remain on study until study completion, when the pre-defined number of events (all-cause mortality) have been reached.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Light Chain (AL) Amyloidosis
Keywords
Light Chain (AL) Amyloidosis, Mayo Stage IV, birtamimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Birtamimab plus Standard of Care Chemotherapy
Arm Type
Experimental
Arm Description
Intravenous administration of 24 mg/kg birtamimab every 28 days. Drug: Standard of Care Chemotherapy. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD) according to the institutional standard of care. Initiation of daratumumab at randomization allowed at the discretion of the investigator
Arm Title
Placebo plus Standard of Care Chemotherapy
Arm Type
Placebo Comparator
Arm Description
Intravenous 0.9% Saline administration as a placebo every 28 days. Drug: Standard of Care Chemotherapy. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD) according to the institutional standard of care. Initiation of daratumumab at randomization allowed at the discretion of the investigator
Intervention Type
Drug
Intervention Name(s)
Birtamimab
Intervention Description
Intravenous administration of 24 mg/kg birtamimab every 28 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intravenous 0.9% Saline administration as a placebo every 28 days
Intervention Type
Drug
Intervention Name(s)
Standard of Care Chemotherapy
Intervention Description
Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care
Primary Outcome Measure Information:
Title
Time to all-cause mortality
Description
Comparison of time to all-cause mortality for birtamimab and placebo control.
Time Frame
Time from the first dose of study drug until the pre-defined number of events (all-cause mortality) have been reached.
Secondary Outcome Measure Information:
Title
6MWT distance
Description
Change from baseline to Month 9 in the 6-Minute Walk Test (6MWT) distance
Time Frame
Month 9
Title
Physical Component Summary (PCS) score of the Short Form-36, version 2 (SF-36v2)
Description
The Short Form-36, version 2 (SF-36v2) is a 36-item self-administered quality-of-life (QoL) questionnaire that measures health on functional status, well-being, and overall evaluation of health. Higher SF-36 scores represent better health. The Physical Component Summary (PCS) is derived primarily from questions regarding physical functioning, physical problems, bodily pain, and general health questions
Time Frame
Month 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Aged ≥18 years and legal age of consent according to local regulations Newly diagnosed and AL amyloidosis treatment-naïve with cardiac involvement Confirmed diagnosis of AL amyloidosis Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP ≥1800 pg/mL and Troponin-T ≥0.025 ng/mL or high sensitivity cardiac troponin T≥40ng/L and dFLC ≥18 mg/dL Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly. Key Exclusion Criteria: Non-AL amyloidosis. NT-proBNP >8500 pg/mL. Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma except for malignancy biomarker of involved/uninvolved serum free light chain ratio ≥100 Subject is eligible for and plans to undergo ASCT or organ transplant during the study. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 Visit. Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease. ECG evidence of acute ischemia or active conduction system abnormalities Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1. Prior radiotherapy within 4 weeks of Month 1-Day 1. Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11- 1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational treatment directed at amyloid . Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonia Romero
Phone
650-837-8550
Email
AFFIRM-ALClinicalTrial@prothena.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christie Nie
Phone
650-837-8550
Email
AFFIRM-ALClinicalTrial@prothena.com
Facility Information:
Facility Name
St. Francis Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale Cancer Center
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Individual Site Status
Recruiting
Facility Name
Smilow Cancer Hospital Care Center at Trumbull
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Individual Site Status
Recruiting
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814-1422
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston University School of Med.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Name
Perlmutter Cancer Center - 38th Street
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University Langone Hospital - Long Island
City
New York
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Duke Clinical Research Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Health - Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Main Campus
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Froedtert and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
SESLHD: St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Icon Cancer Centre - Wesley
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Individual Site Status
Recruiting
Facility Name
Icon Cancer Center
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Paracelsus Medical University
City
Salzburg
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universität
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien
City
Wien
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermine Agis, MD
First Name & Middle Initial & Last Name & Degree
Hermine Agis
Facility Name
AZ Sint-Jan Brugge-Oostende AV
City
Oostende
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur (Site Godinne)
City
Yvoir
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Royal Victoria Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A1A1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultní Nemocnice Brno
City
Brno
State/Province
Jihormoravsky Kraj
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice ostrava
City
Ostrava-Poruba
State/Province
Moravian-Silesian
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Všeobecná fakultní nemocnice v Praze
City
Praha
State/Province
Prague
ZIP/Postal Code
12808
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Odense Universitetshospital
City
Odense
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Hôpital Bretonneau
City
Tours Cedex 9
State/Province
Centre
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Haut-Lévêque
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Necker
City
Paris Cedex 15
State/Province
Ill-de-France
ZIP/Postal Code
75743
Country
France
Individual Site Status
Recruiting
Facility Name
Pitie-Salpêtrière Hospital
City
Paris
State/Province
Ill-de-France
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpitaux de Brabois
City
Vandœuvre-lès-Nancy
State/Province
Lorraine
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Rangueil
City
Toulouse Cedex 9
State/Province
Midi-Pyrenees
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Claude Huriez
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Nantes
City
Nantes
State/Province
Pays De La Loire
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Poitiers
City
Poitiers
State/Province
Vienne
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Henri Mondor, Creteil
City
Créteil
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Limoges
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Uniklinik Köln
City
Köln
State/Province
Baden-Württemberg
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Medicine Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charité Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Alexandra General Hospital
City
Athens
State/Province
Attica
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Name
Theagenio Anti-Cancer Hospital of Thessaloniki
City
Thessaloníki
State/Province
Central Macedonia
ZIP/Postal Code
54007
Country
Greece
Individual Site Status
Recruiting
Facility Name
University Hospital of Patras
City
Patra
State/Province
Peloponnese
ZIP/Postal Code
26504
Country
Greece
Individual Site Status
Recruiting
Facility Name
Pécsi Tudományegyetem Klinikai Központ
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7622
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Szent-Györgyi Albert Klinikai Központ
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Központ
City
Debrecen
State/Province
Hajdu-Bihar County
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem - I. sz. Belgyógyászati Klinika
City
Budapest
ZIP/Postal Code
1087
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Cork University Hospital
City
Cork
State/Province
Munster
ZIP/Postal Code
T12 DFK4
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Name
Cancer Clinical Trials and Research Unit, Beaumont Hospital
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Bnai Zion Medical Center
City
Haifa
State/Province
Haifa District
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center
City
Haifa
State/Province
Haifa District
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center
City
Jerusalem
State/Province
Jerusalem District
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Ashkelon
State/Province
Southern District
ZIP/Postal Code
7830604
Country
Israel
Individual Site Status
Recruiting
Facility Name
Samson Assuta Ashdod Hospital
City
Ashdod
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Recruiting
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali Civili
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Policlinico Gaspare Rodolico - San Marco
City
Catania
ZIP/Postal Code
95125
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Umberto I - Policlinico di Roma
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Kyoto Kuramaguchi Medical Center
City
Kita
State/Province
Kyoto
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shinshu University Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-0802
Country
Japan
Individual Site Status
Recruiting
Facility Name
Jichi medical university hospital
City
Shimotsuke
State/Province
Tochigi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokushima University Hospital
City
Kuramoto
State/Province
Tokushima
Country
Japan
Individual Site Status
Recruiting
Facility Name
Red Cross Medical Center
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya City University Hospital
City
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1247
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
State/Province
Gyeongsangbugdo
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Gwangju
State/Province
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital
City
Seoul
State/Province
Seoul Teugbyeols
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
602702
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea - Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713GZ
Country
Netherlands
Individual Site Status
Withdrawn
Facility Name
Klinika Hematologii i Transplantologii
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar e Universitário de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria
City
Lisboa
ZIP/Postal Code
1649-028
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Son Espases
City
Palma De Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Son Llatzer
City
Palma De Mallorca
State/Province
Balearic Islands
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Català d'Oncologia - Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospital Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra -Madrid
City
Pamplona
State/Province
Navarra
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Universidad de Navarra - Pamplona
City
Pamplona
State/Province
Navarre
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Canarias
City
Tenerife
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38320
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Català d'Oncologia - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Josep Trueta ICO Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Complejo Asistencial Universitario de Salamanca - Hospital Clínico
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politècnic la Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Vila-real
ZIP/Postal Code
1254
Country
Spain
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
10047
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Ankara UMF
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34320
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Ege Universitesi Tip Fakultesi
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B152SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
High Heaton
State/Province
England
ZIP/Postal Code
NE77DN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Barts Health NHS Trust
City
London
State/Province
England
ZIP/Postal Code
EC1A7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Univiersity College London Hospitals
City
London
State/Province
England
ZIP/Postal Code
NW12PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M139WL
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG51PB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Belfast City Hospital
City
Belfast
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

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