A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
MajesTEC-9
A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide
4 other identifiers
interventional
614
23 countries
209
Brief Summary
The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2023
Longer than P75 for phase_3
209 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2022
CompletedFirst Posted
Study publicly available on registry
October 7, 2022
CompletedStudy Start
First participant enrolled
March 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 13, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2031
ExpectedApril 13, 2026
April 1, 2026
2.5 years
October 5, 2022
April 10, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Part 1: Progression-free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.
Up to 9 years
Part 2: Number of Participants Reporting Cytokine Release Syndrome (CRS) Cases by Severity
Severity for CRS will be graded as follows: Grade 1: Fever (Temperature greater than or equal to \[\>=\] 38°C); Grade 2: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring low-flow nasal cannula or blow-by; Grade 3: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: Fever (Temperature \>=38°C) with either: hypotension requiring multiple vasopressors (excluding vasopressin), and/or hypoxia requiring positive pressure and Grade 5: Death.
Up to 9 years
Secondary Outcomes (19)
Part 1 and 2: Overall Response (Partial Response [PR] or Better)
Up to 9 years
Part 1 and 2: Very Good Partial Response (VGPR) or Better Response
Up to 9 years
Part 1 and 2: Complete Response (CR) or Better Response
Up to 9 years
Part 1: Duration of Response (DOR)
Up to 9 years
Part 1: Time to Next Treatment (TTNT)
Up to 9 years
- +14 more secondary outcomes
Study Arms (2)
Teclistamab
EXPERIMENTALParticipants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2.
Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd)
EXPERIMENTALParticipants will receive either PVd or Kd based on principal investigator's choice during Part 1 of the study.
Interventions
Bortezomib will be administered subcutaneously.
Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.
Carfilzomib will be administered intravenously.
Teclistamab will be administered subcutaneously.
Pomalidomide will be administered orally.
Eligibility Criteria
You may qualify if:
- Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to International Myeloma Working Group (IMWG) diagnostic criteria (b) Measurable disease at screening as defined by any of the following: (1) Serum M-protein level greater than or equal to (\>=)0.5 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
- Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
- Must be willing and able to adhere to the lifestyle restrictions specified in this protocol
You may not qualify if:
- Received any prior B cell maturation antigen (BCMA)-directed therapy
- A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (\>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (\>)159 millimeters of mercury (mmHg) or diastolic blood pressure \>99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade \>=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event \[AE\] related to carfilzomib)
- Received a maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14 days prior to randomization
- Received a live, attenuated vaccine within 4 weeks before randomization
- Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma
- Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (211)
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
MemorialCare Long Beach Medical Center
Long Beach, California, 90806, United States
University of California Irvine
Orange, California, 92868, United States
PIH Health Hospital
Whittier, California, 90602, United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80218, United States
University of Connecticut
Farmington, Connecticut, 06030, United States
University of Miami Sylvester Cancer Center
Miami, Florida, 33136, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Mission Cancer Blood
Waukee, Iowa, 50263, United States
East Jefferson General Hospital Bone Marrow Transport Clinic
Metairie, Louisiana, 70006, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Saint Lukes Hospital Saint Lukes Cancer Specialists
Chesterfield, Missouri, 63017, United States
Cooper Health System MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032, United States
Durham VAMC
Durham, North Carolina, 27705, United States
Penn Medicine Lancaster General Health
Lancaster, Pennsylvania, 17601, United States
Tennessee Oncology
Nashville, Tennessee, 37203, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Michael E DeBakey VA Medical Center
Houston, Texas, 77030, United States
Harris Health Smith Clinic
Houston, Texas, 77054, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia, 22060, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
NorthWest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Blacktown Hospital
Blacktown, 2148, Australia
St Vincents Hospital Melbourne
Fitzroy, 3065, Australia
Box Hill Hospital
Melbourne, 3128, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Sir Charles Gairdner Hospital
Nedlands, 6009, Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg, 5020, Austria
Medical University Vienna MUV
Vienna, A-1090, Austria
Algemeen Ziekenhuis Klina
Brasschaat, 2930, Belgium
Jolimont
Haine-St-Paul, 7100, Belgium
Az Groeninge
Kortrijk, 8500, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven, 3000, Belgium
CHR de la Citadelle
Liège, 4000, Belgium
Hospitais Integradaos da Gavea S/A - DF Star
Brasília, 70390-140, Brazil
Fundacao Universidade de Caxias do Sul
Caxias do Sul, 95070 560, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, 81520 060, Brazil
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
Joinville, 89201-260, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062 000, Brazil
Complexo Hospitalar de Niteroi
Niterói, 24020-073, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, 22775-001, Brazil
Hospital Sao Rafael
Salvador, 41253-190, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, 15090-000, Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, 01308-901, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, 01321-001, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01323-001, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, 01401 002, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Clinica Medica Sao Germano LTDA
São Paulo, 04537 081, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
Lakeridge Health Oshawa
Oshawa, Ontario, L1G2B9, Canada
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
Beijing Chaoyang Hospital
Beijing, 100020, China
BeiJing JiShuiTan Hospital
Beijing, 102208, China
The First Bethune Hospital of Jilin University
Changchun, 130021, China
The Third Xiangya Hospital, Central South University
Changsha, 410013, China
Sichuan Provincial Peoples Hospital
Chengdu, 610032, China
Chongqing University Cancer Hospital
Chongqing, 400030, China
Fujian Meidical University Union Hospital
Fuzhou, 350001, China
Sun Yat -Sen University Cancer Center
Guangzhou, 511363, China
First affiliated Hospital of Zhejiang University 1
Hangzhou, 310003, China
First affiliated Hospital of Zhejiang University
Hangzhou, 310003, China
Harbin medical university cancer hospital
Harbin, 150000, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Shanghai Fourth People s Hospital
Shanghai, 200434, China
Shengjing Hospital Of China Medical University
Shenyang, 110055, China
Shenzhen 2nd People's Hospital
Shenzhen, 518025, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
Institute of Hematology and Blood Diseases Hospital
Tianjin, 301617, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Wuhan Union Hospital
Wuhan, 430023, China
Wuxi People s Hospital
Wuxi, 214023, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8200, Denmark
Rigshospitalet
Copenhagen, DK-2100, Denmark
Regionshospitalet Godstrup
Herning, 7400, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
CHU Amiens - Hopital Sud
Amiens, 80000, France
Hôpital Côte de Nacre
Caen, 14000, France
CHU Grenoble
Grenoble, 38700, France
Centre Hospitalier du Mans
Le Mans, 72037, France
Hopital Saint Vincent de Paul
Lille, 59020, France
CHU de Montpellier Hopital Saint Eloi
Montpellier, 34090, France
CHU Nantes
Nantes, 44000, France
Hopital Saint-Antoine
Paris, 75012, France
Hopital de la Pitie Salpetriere
Paris, 75013, France
Hopital Necker Enfants Malades
Paris, 75743, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31100, France
CHU de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, 54500, France
Medizinische Universitat Lausitz Carl Thiem
Cottbus, 03048, Germany
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Universitätsmedizin Greifswald
Greifswald, 17475, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Giessen und Marburg GmbH
Marburg, 35043, Germany
Universitatsklinikum Tubingen
Tübingen, 72076, Germany
Universitatsklinikum Ulm
Ulm, 89070, Germany
Heinrich-Braun-Klinikum gGmbH
Zwickau, 08060, Germany
Alexandra General Hospital of Athens
Athens Attica, 115 28, Greece
Agios Andreas General Hospital of Patra
Pátrai, 263 35, Greece
G Papanikolaou Hospital of Thessaloniki
Thessaloniki, 570 10, Greece
Fortis Memorial Research Institute
Gūrgaon, 122002, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur, 302017, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004, India
Hillel Yaffe Medical Center
Hadera, 3810101, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Carmel Medical Center
Haifa, 3436212, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
A O U Sant Orsola Malpighi
Bologna, 40138, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, 90127, Italy
Ospedale Santa Chiara AO Universitaria Pisana
Pisa, 56126, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123, Italy
Campus Bio Medico di Roma
Roma, 00128, Italy
A O Universitaria Senese Ospedale Santa Maria alle Scotte
Siena, 53100, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Turin, 10126, Italy
ASUI Santa Maria della Misericordia di Udine
Udine, 33100, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, 21100, Italy
Institute of Science Tokyo Hospital
Bunkyō City, 113 8519, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
Ogaki Municipal Hospital
Gifu, 503-8502, Japan
National Hospital Organization Shibukawa Medical Center
Gunma, 377-0280, Japan
Kansai Medical University Hospital
Hirakata, 573 1191, Japan
Hitachi General Hospital
Hitachi, 317-0077, Japan
Saitama Medical University Hospital
Iruma-gun, 350-0495, Japan
Kameda Medical Center
Kamogawa, 296-8602, Japan
National Cancer Center Hospital East
Kashiwa, 277 8577, Japan
Kurashiki Central Hospital
Kurashiki, 710-8602, Japan
Matsuyama Red Cross Hospital
Matsuyama, 790-8524, Japan
Aichi Medical University Hospital
Nagakute, 480-1195, Japan
JRC Nagasaki Genbaku Hospital
Nagasaki, 852-8511, Japan
Niigata University Medical And Dental Hospital
Niigata, 951 8520, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Osaka Metropolitan University Hospital
Osaka, 545 8586, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Juntendo University Hospital
Tokyo, 113-0033, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550, Japan
Yamagata University Hospital
Yamagata, 990 2331, Japan
Yamanashi Prefectural Central Hospital
Yamanashi, 400-8506, Japan
Hospital Pulau Pinang
George Town, 10450, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, 88200, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Subang Jaya Medical Centre
Subang Jaya, 47500, Malaysia
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
VUMC Amsterdam
Amsterdam, 1081 HV, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9700 RB, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214, Poland
Pratia Onkologia Katowice
Katowice, 40 519, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, 25 734, Poland
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
Lublin, 20-081, Poland
Uls Almada Seixal - Hosp. Garcia de Orta
Almada, 2805-267, Portugal
Uls Braga - Hosp. Braga
Braga, 4710-243, Portugal
Champalimaud Foundation Champalimaud Centre
Lisbon, 1400-038, Portugal
Instituto Portugues de Oncologia
Porto, 4200072, Portugal
Uls Gaia Espinho
Vila Nova de Gaia, 4434-502, Portugal
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Institut Catala d Oncologia L Hospitalet
L'Hospitalet de Llobregat, 08908, Spain
Hosp. de Leon
León, 24008, Spain
Hosp. Univ. Infanta Leonor
Madrid, 28031, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Gral. Univ. J.M. Morales Meseguer
Murcia, 30008, Spain
Hospital Universitario Central de Asturias
Oviedo, 33011, Spain
Hosp. Son Llatzer
Palma de Mallorca, 07198, Spain
Hosp. Montecelo
Pontevedra, 36071, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, 28223, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Falu Lasarett Medicinkliniken Falun
Falun, 791 82, Sweden
Helsingborgs lasarett
Helsingborg, 25287, Sweden
Akademiska Sjukhuset
Uppsala, 751 85, Sweden
Ankara Gulhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06620, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06680, Turkey (Türkiye)
Antalya Training And Research Hospital
Antalya, 07100, Turkey (Türkiye)
Pamukkale University Medical Faculty
Denizli, 20070, Turkey (Türkiye)
Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Ondokuz Mayis University
Samsun, 55280, Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW, United Kingdom
Colchester Hospital University NHS
Colchester, CO4 5JL, United Kingdom
The Clatterbridge Cancer Centre
Liverpool, L7 8YA, United Kingdom
Chelsea And Westminster Hospital
London, SW10 9NH, United Kingdom
St Georges Hospital
London, SW17 0QT, United Kingdom
James Cook University Hospital
Middlesbrough, Ts4 3Bw, United Kingdom
Norfolk and Norwich University Hospital
Norwich, NR4 7UY, United Kingdom
Royal Stoke University Hospital
Staffordshire, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 5, 2022
First Posted
October 7, 2022
Study Start
March 29, 2023
Primary Completion
October 13, 2025
Study Completion (Estimated)
August 31, 2031
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu