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

NCT03201965 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: CR10819354767414AMY30012016-001737-272024-511967-26-00
• Study Type: interventional
• Target: 416
• Locations: 22 countries
• Sites: 140

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.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Overall Complete Hematologic Response (CHR)

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

  Up to 2.4 years

Secondary Outcomes (16)

• Major Organ Deterioration Progression-Free Survival (MOD-PFS)

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

• Overall Survival (OS)

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

• Organ Response Rate (OrRR) at 6 Months: Cardiac Response

  Month 6

• Organ Response Rate (OrRR) at 6 Months: Renal Response

  Month 6

• Organ Response Rate (OrRR) at 6 Months: Liver Response

  Month 6

Study Arms (2)

CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)

ACTIVE COMPARATOR

Participants will receive dexamethasone (40 milligrams \[mg\] orally or intravenous \[IV\] dose), followed by cyclophosphamide (300 milligram per meter square \[mg/m\^2\] orally or IV dose), then bortezomib (1.3 mg/m\^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.

Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone, 40 mg

CyBorD plus Daratumumab

EXPERIMENTAL

Participants will receive dexamethasone (20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m\^2 orally or IV dose weekly) and bortezomib (1.3 mg/m\^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.

Drug: Daratumumab

Interventions

Cyclophosphamide DRUG

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

CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)

Bortezomib DRUG

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

CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)

Dexamethasone, 40 mg DRUG

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.

CyBorD alone (cyclophosphamide/bortezomib/dexamethasone)

Daratumumab DRUG

Participants will receive 1800 mg of daratumumab subcutaneously.

CyBorD plus Daratumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (140)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Winship Cancer Institute Emory University

Atlanta, Georgia, 30322, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215-5418, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School Of Medicine

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Wake Forest University Health Sciences - Cardiovascular Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health And Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

Box Hill Hospital

Box Hill, 3128, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, 6009, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

Princess Alexandra Hospital

Woolloongabba, 4102, Australia

Location

Institut Jules Bordet

Anderlecht, 1070, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

Az Groeninge

Kortrijk, 8500, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

Hospital das Clinicas de Porto Alegre

Porto Alegre, 90035-903, Brazil

Location

Sociedade Pernambucana de Combate ao Cancer

Recife, 50040-000, Brazil

Location

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

Rio de Janeiro, 22775 001, Brazil

Location

Hospital Sao Rafael

Salvador, 41253 190, Brazil

Location

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

São José do Rio Preto, 15090-000, Brazil

Location

Clinica Sao Germano

São Paulo, 01455 010, Brazil

Location

Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE

São Paulo, 04039-004, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403-010, Brazil

Location

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, T2N 5G2, Canada

Location

Alberta Health Services

Edmonton, Alberta, T6G 1Z2, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

London Health Sciences Center

London, Ontario, N6A 5W9, Canada

Location

University Health Network UHN Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Peking University First Hospital

Beijing, 100034, China

Location

Peking University People s Hospital

Beijing, 100044, China

Location

First affiliated Hospital of Zhejiang University

Hangzhou, 310020, China

Location

Ruijin Hospital Shanghai Jiao Tong University

Shanghai, 200025, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325000, China

Location

Aarhus University Hospital

Aarhus N, DK-8200, Denmark

Location

Dep. of Hematology, Rigshospitalet

Copenhagen, 2400, Denmark

Location

Odense Universitets Hospital

Odense, 5000, Denmark

Location

CHU Dijon

Dijon, 21000, France

Location

Hopital Claude Huriez

Lille, 59037, France

Location

CHU de Limoges - Fédération Hépatologie

Limoges, 87000, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Chu Hotel Dieu

Nantes, 44035, France

Location

Hopital Saint Louis

Paris, 75475, France

Location

Centre hospitalier Lyon-Sud

Pierre-Bénite, 69495, France

Location

CHU De Poitiers

Poitiers, 86000, France

Location

CHU Rangueil

Toulouse, 31400, France

Location

CHU Bretonneau

Tours, 37044, France

Location

CHU de Nancy_ Hopital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Charite Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Heinrich-Heine-Universität Düsseldorf

Düsseldorf, 40225, Germany

Location

Universitatsklinikum Essen

Essen, 45122, Germany

Location

HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH

Hamburg, 22767, Germany

Location

Universitaetsklinikum Heidelberg Medizinische Klinik V

Heidelberg, 69120, Germany

Location

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

Tübingen, 72076, Germany

Location

Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii

Würzburg, 97080, Germany

Location

Alexandra General Hospital of Athens

Athens, 11528, Greece

Location

University General Hospital of Rio

Pátrai, 26500, Greece

Location

Semmelweis Egyetem I.Belgyogyaszati Klinika

Budapest, 1083, Hungary

Location

Semmelweis Egyetem I.Belgyogyaszati Klinika

Budapest, 1088, Hungary

Location

Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely

Budapest, 1097, Hungary

Location

Carmel Hospital

Haifa, 34362, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Assaf Ha'Rofeh Medical Center

Ẕerifin, 70300, Israel

Location

Policlinico di Bari

Bari, 70124, Italy

Location

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

Bologna, 40138, Italy

Location

Casa di Cura La Maddalena

Palermo, 90146, Italy

Location

Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

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

Roma, 00161, Italy

Location

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

Torino, 10126, Italy

Location

Fukushima Medical University Hospital

Fukushima, 960 1295, Japan

Location

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, 730-8619, Japan

Location

Teine Keijinkai Hospital

Hokkaido, 006-8555, Japan

Location

Kanazawa University Hospital

Kanazawa, 920 8641, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Kyoto Kuramaguchi Medical Center

Kyoto, 603-8151, Japan

Location

Shinshu University Hospital

Matsumoto, 390 8621, Japan

Location

Matsuyama Red Cross Hospital

Matsuyama, 790-8524, Japan

Location

Nagoya City University Hospital

Nagoya, 467 8602, Japan

Location

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

Location

Japanese Red Cross Medical Center

Shibuya City, 150-8935, Japan

Location

Tokushima University Hospital

Tokushima, 770-8503, Japan

Location

Centro de Investigación Farmacéutica Especializada

Guadalajara, 44160, Mexico

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460, Mexico

Location

UMCG

Groningen, 9713 GZ, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CN, Netherlands

Location

Haga ziekenhuis

The Hague, 2545 AA, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, 5504 DB, Netherlands

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

Chorzów, 41-500, Poland

Location

SKPP UM w Poznaniu

Poznan, 60-569, Poland

Location

Instytut Hematologii i Transfuzjologii

Warsaw, 02 776, Poland

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Location

Inst. Cat. D'Oncologia-Badalona

Badalona, 08916, Spain

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Location

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Location

Hosp. Univ. de Canarias

San Cristóbal de La Laguna, 38320, Spain

Location

Hosp. Univ. Dr. Peset

Valencia, 46017, Spain

Location

South Elvsborg Hospital

Borås, 501 82, Sweden

Location

Skanes universitetssjukhus

Lund, 221 85, Sweden

Location

Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

Ankara, 06590, Turkey (Türkiye)

Location

Akdeniz University Medical Faculty

Antalya, 7059, Turkey (Türkiye)

Location

Ondokuz Mayis Universitesi Tip Fakultesiy

Atakum, 55270, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Tip Fakultesi

Izmir, 35340, Turkey (Türkiye)

Location

Erciyes University Medical Faculty

Talas, 38039, Turkey (Türkiye)

Location

University Hospitals Birmingham NHS Trust,

Birmingham, B15 2TH, United Kingdom

Location

University College Hospital

London, NW1 2PG, United Kingdom

Location

Related Publications (4)

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

  PMID: 36862168 DERIVED

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

  PMID: 36444227 DERIVED

• 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.

  PMID: 34192431 DERIVED

• 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.

  PMID: 32244252 DERIVED

MeSH Terms

Conditions

Amyloidosis

Interventions

Cyclophosphamide; Bortezomib; Dexamethasone; daratumumab

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Senior Director
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 28, 2017
• Study Start: October 5, 2017
• Primary Completion: February 14, 2020
• Study Completion: November 19, 2024
• Last Updated: November 26, 2025
• Results First Posted: March 4, 2021

Record last verified: 2025-11

Locations

IT (6); SE (2); BR (8); TU (6); US (29); AU (4); DE (7); CA (6); ES (10); ME (2); CN (5); DK (3); GR (2); KR (5); NL (5); HU (3); GB (2); IL (5); BE (4); PL (3); FR (11); JP (12)