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

A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis

The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

Study Overview

• Status: Active, not recruiting
• Conditions: Amyloidosis
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Bortezomib; Drug: Dexamethasone, 40 mg; Drug: Daratumumab

Detailed Description

Participant involved in study for approx. 8 years duration includes Screening Phase (complete clinical evaluation will be done), Treatment Phase (monitoring of adverse events (AEs), laboratory abnormalities and clinical response), Post-Treatment Observation Phase (disease evaluations will be done) and a Long-term Follow-up Phase (Subsequent anticancer treatment, response to subsequent treatment, date of progression and survival status will be obtained every 16 weeks).The primary hypothesis is that daratumumab in combination with CyBorD will improve the overall complete hematological response rate compared to CyBorD alone in AL amyloidosis participants. Safety will be assessed by AEs, laboratory test results, electrocardiogram, vital sign measurements, physical examination, and Eastern Cooperative Oncology Group (ECOG) performance status.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Box Hill, Australia, 3128
    • Box Hill Hospital
  • Nedlands, Australia, 6009
    • Sir Charles Gairdner Hospital
  • Westmead, Australia, 2145
    • Westmead Hospital
  • Woolloongabba, Australia, 4102
    • Princess Alexandra Hospital
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet
  • Gent, Belgium, 9000
    • UZ Gent
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven
• Brazil
  • Porto Alegre, Brazil, 90035-903
    • Hospital das Clínicas de Porto Alegre
  • Recife, Brazil, 50040-000
    • Sociedade Pernambucana de Combate ao Cancer
  • Rio de Janeiro, Brazil, 22775-001
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Salvador, Brazil, 41253-190
    • Hospital Sao Rafael
  • Sao Jose do Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
  • Sao Paulo, Brazil, 04039-004
    • Instituto de Assistencia Medica ao Servidor Publico Estadual IAMSPE
  • São Paulo, Brazil, 05403-010
    • Hospital das Clínicas da Faculdade de Medicina da USP
  • São Paulo, Brazil, 01455-010
    • Clinica Sao Germano
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Alberta Health services
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Alberta Health services
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Center
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network (UHN) Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre
• China
  • Beijing, China, 100044
    • Peking University People's Hospital
  • Beijing, China, 100034
    • Peking University First Hospital
  • Hangzhou, China, 310020
    • First Affiliated Hospital of Zhejiang University
  • Shanghai, China, 200025
    • Ruijin Hospital, Shanghai Jiao Tong University
  • Wenzhou, China, 325000
    • The First Affiliated Hospital of Wenzhou Medical University
• Denmark
  • Aarhus C, Denmark, 8000
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2400
    • Dep. of Hematology, Rigshospitalet
  • Odense, Denmark, 5000
    • Odense Universitets Hospital
• France
  • Dijon, France, 21000
    • CHU Dijon
  • Lille cedex, France, 59037
    • Hôpital Claude Huriez
  • Limoges, France, 87000
    • CHU de Limoges - Fédération Hépatologie
  • Marseille, France, 13273
    • Institut Paoli Calmettes
  • Nantes cedex 01, France, 44035
    • CHU Hôtel Dieu
  • PARIS cedex 10, France, 75475
    • Hopital Saint Louis
  • Pierre - Bénite cedex, France, 69495
    • Centre Hospitalier Lyon-Sud
  • Poitiers, France, 86000
    • CHU de Poitiers
  • Toulouse, France, 31400
    • CHU Rangueil
  • Tours cedex, France, 37044
    • CHU Bretonneau
  • Vandoeuvre les Nancy, France, 54511
    • CHU de Nancy_ Hopital Brabois
• Germany
  • Berlin, Germany, 12203
    • Charite Campus Benjamin Franklin
  • Düsseldorf, Germany, 40225
    • Heinrich-Heine-Universität Düsseldorf
  • Essen, Germany, 45122
    • Universitätsklinikum Essen
  • Hamburg, Germany, 22767
    • HOPA-Hämatologisch-Onkologische Praxis Altona MVZ GmbH
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg Medizinische Klinik V
  • Tübingen, Germany, 72076
    • Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii
• Greece
  • Athens, Greece, 11528
    • Alexandra General Hospital of Athens
  • Patra, Greece, 26500
    • University General Hospital of Rio
• Hungary
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem I.Belgyogyaszati Klinika
  • Budapest, Hungary, 1097
    • Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem I.Belgyogyaszati Klinika
• Israel
  • Haifa, Israel, 34362
    • Carmel Hospital
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Ramat-Gan, Israel, 52621
    • Sheba Medical Center
  • Tel-Aviv, Israel, 6423906
    • Sourasky Medical Center
  • Zerifin, Israel, 70300
    • Assaf Ha'Rofeh Medical Center
• Italy
  • Bari, Italy, 70124
    • Policlinico di Bari
  • Bologna, Italy, 40138
    • Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi
  • Palermo, Italy, 90146
    • Casa di Cura La Maddalena
  • Pavia, Italy, 27100
    • Amyloidosis Research and Treatment Center, Fondazione IRCCS Policlinico San Matteo
  • Roma, Italy, 00161
    • Dipartimento Di Biotecnologie Cellulari Ed Ematologia-Università ''La Sapienza'',Policlinico Umberto I
  • Torino, Italy, 10126
    • A.O.U. Citta della Salute e della Scienza
• Japan
  • Fukushima, Japan, 960-1295
    • Fukushima Medical University Hospital
  • Hiroshima, Japan, 730-8619
    • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
  • Hokkaido, Japan, 006-8555
    • Teine Keijinkai Hospital
  • Kanazawa, Japan, 920-8641
    • Kanazawa University Hospital
  • Kumamoto-City, Japan, 860-8556
    • Kumamoto University Hospital
  • Kyoto, Japan, 603-8151
    • Kyoto Kuramaguchi Medical Center
  • Matsumoto, Japan, 390-8621
    • Shinshu University Hospital
  • Matsuyama, Japan, 790-8524
    • Matsuyama Red Cross Hospital
  • Nagoya, Japan, 467 8602
    • Nagoya City University Hospital
  • Okayama, Japan, 701-1192
    • National Hospital Organization Okayama Medical Center
  • Shibuya, Japan, 150-8935
    • Japanese Red Cross Medical Center
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea Seoul St. Mary'S Hospital
• Mexico
  • Guadalajara, Mexico, 44160
    • Centro de Investigación Farmacéutica Especializada
  • Monterrey, Mexico, 64460
    • Hospital Universitario Dr Jose Eleuterio Gonzalez
• Netherlands
  • Den Haag, Netherlands, 2545 AA
    • Haga ziekenhuis
  • Groningen, Netherlands, 9713 GZ
    • UMCG
  • Rotterdam, Netherlands, 3015 CN
    • Erasmus MC
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht
  • Veldhoven, Netherlands, 5504 DB
    • Máxima Medisch Centrum
• Poland
  • Chorzów, Poland, 41-500
    • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
  • Poznan, Poland, 60-569
    • SKPP UM w Poznaniu
  • Warszawa, Poland, 02-776
    • Instytut Hematologii i Transfuzjologii
• Spain
  • Badalona, Spain, 08916
    • Inst. Cat. D'Oncologia-Badalona
  • Barcelona, Spain, 08035
    • Hosp. Univ. Vall D Hebron
  • Barcelona, Spain, 08036
    • Hosp. Clinic de Barcelona
  • Madrid, Spain, 28040
    • Hosp. Univ. Fund. Jimenez Diaz
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28034
    • Hosp. Univ. Ramon Y Cajal
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Salamanca, Spain, 37007
    • Hosp. Clinico Univ. de Salamanca
  • San Cristóbal de La Laguna, Spain, 38320
    • Hosp. Univ. de Canarias
  • Valencia, Spain, 46017
    • Hosp. Univ. Dr. Peset
• Sweden
  • Boras, Sweden, 501 82
    • South Elvsborg Hospital
  • Lund, Sweden, 221 85
    • Skånes universitetssjukhus
• Turkey
  • Ankara, Turkey, 06590
    • Ankara Universitesi Tip Fakultesi Cebeci Hastanesi
  • Antalya, Turkey, 7059
    • Akdeniz University Medical Faculty
  • Atakum, Turkey, 55270
    • Ondokuz Mayis Universitesi Tip Fakultesi
  • Istanbul, Turkey, 34093
    • Istanbul University Istanbul Medical Faculty
  • Izmir, Turkey, 35340
    • Dokuz Eylul Universitesi Tip Fakultesi
  • Talas, Turkey, 38039
    • Erciyes University Medical Faculty
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • University Hospitals Birmingham NHS Trust,
  • London, United Kingdom, NW1 2PG
    • University College Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute Emory University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
    • Boston, Massachusetts, United States, 02215-5418
      • Dana Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences - Cardiovascular Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas, MD Anderson Cancer Center
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98109-1023
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance

• Measurable disease of amyloid light-chain (AL) amyloidosis as defined by at least one of the following:

  1. serum monoclonal (M)-protein greater than or equal (>=) 0.5 grams/deciliter (g/dL) by protein electrophoresis (routine serum protein electrophoresis and immunofixation [IFE] performed at a central laboratory)
  2. serum free light chain greater than or equal to (>=) 50 milligram/Liter (mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) >= 50 mg/L
• One or more organs impacted by AL amyloidosis according to consensus guidelines
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

Exclusion Criteria:

• Prior therapy for AL amyloidosis or multiple myeloma including medications that target CD38, with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to randomization
• Previous or current diagnosis of symptomatic multiple myeloma, including the presence of lytic bone disease, plasmacytomas, >= 60 percent (%) plasma cells in the bone marrow, or hypercalcemia

• Evidence of significant cardiovascular conditions as specified below:

  1. NT-ProBNP > 8500 nanogram per liter (ng/L)
  2. New York Heart Association (NYHA) classification IIIB or IV heart failure
  3. Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (eg, prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram [ECG] changes) or uncorrected valvular disease and not primarily due to AL amyloid cardiomyopathy
  4. Inpatient admission to a hospital for unstable angina or myocardial infarction within the last 6 months prior to first dose or percutaneous cardiac intervention with recent stent within 6 months or coronary artery bypass grafting within 6 months
  5. For participants with congestive heart failure, cardiovascular-related hospitalizations within 4 weeks prior to randomization
  6. Participants with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular (AV) nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillators [ICD] is indicated but not placed (participants who do have a pacemaker/ICD are allowed on study)
  7. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) > 500 milliseconds (msec). Participants who have a pacemaker may be included regardless of calculated QTc interval
  8. Supine systolic blood pressure < 90 millimeter of mercury (mmHg), or symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure upon standing of > 20 mmHg despite medical management (eg, midodrine, fludrocortisones) in the absence of volume depletion
• Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted
• Known to be seropositive for human immunodeficiency virus (HIV)

• Any one of the following:

  1. Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (ie, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded
  2. Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
• Grade 2 sensory or Grade 1 painful peripheral neuropathy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CyBorD alone (cyclophosphamide/bortezomib/dexamethasone); Participants will receive dexamethasone (40 milligrams [mg] orally or intravenous [IV] dose), followed by cyclophosphamide (300 milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.	Drug: Cyclophosphamide; Participants will receive 300 mg/m^2 of cyclophosphamide as an oral or IV dose.; Drug: Bortezomib; Participants will receive 1.3 mg/m^2 of bortezomib as an subcutaneous (SC) injection.; Drug: Dexamethasone, 40 mg; Participants of CyBorD alone arm will receive 40 mg dexamethasone orally or IV dose. Participants of CyBorD plus daratumumab arm will receive dexamethasone 20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing to make a total of 40 mg.
Experimental: CyBorD plus Daratumumab; Participants will receive dexamethasone (20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.	Drug: Daratumumab; Participants will receive 1800 mg of daratumumab subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): February 14, 2020
• Study Completion (Estimated): August 16, 2024

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: June 27, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Dexamethasone; Cyclophosphamide; Daratumumab; Bortezomib
• Other Study ID Numbers: CR108193; 2016-001737-27 (EudraCT Number); 54767414AMY3001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No