A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
MonumenTAL-3
A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy
4 other identifiers
interventional
864
18 countries
216
Brief Summary
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2022
Longer than P75 for phase_3
216 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
June 22, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedStudy Start
First participant enrolled
October 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 25, 2028
April 13, 2026
April 1, 2026
4.8 years
June 22, 2022
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.
Up to 6 years 6 months
Secondary Outcomes (25)
Overall Response (Partial Response [PR] or Better)
Up to 6 years 6 months
Very Good Partial Response (VGPR) or Better Rate
Up to 6 years 6 months
Complete Response (CR) or Better Rate
Up to 6 years 6 months
Overall Minimal Residual Disease (MRD) Negative CR
Up to 6 years 6 months
Overall Survival (OS)
Up to 6 years 6 months
- +20 more secondary outcomes
Study Arms (3)
Arm A: Talquetamab Subcutaneous (SC) in Combination With Daratumumab SC and Pomalidomide (Tal-DP)
EXPERIMENTALParticipants will receive talquetamab and daratumumab as SC injections; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Arm B: Daratumumab in Combination With Pomalidomide and Dexamethasone (DPd)
EXPERIMENTALParticipants will receive daratumumab as SC injection; pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Arm C: Talquetamab SC in Combination With Daratumumab SC (Tal-D)
EXPERIMENTALParticipants will receive talquetamab and daratumumab as SC injection; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
Interventions
Talquetamab will be administered subcutaneously.
Daratumumab will be administered subcutaneously.
Pomalidomide will be administered orally.
Dexamethasone will be administered orally or intravenously.
Eligibility Criteria
You may qualify if:
- Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (\>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level \>= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain \>= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
- Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (\>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (\<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (\<=) 60 days after cessation of treatment
- Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received \>=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
- Documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or after their last regimen
- Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment
You may not qualify if:
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
- Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
- Received prior pomalidomide therapy
- A maximum cumulative dose of corticosteroids to \>=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug
- Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
- Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (216)
The University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Norwalk Hospital-oncology
Norwalk, Connecticut, 06850, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
University of Miami Health System
Miami, Florida, 33136, United States
University Of Illinois
Chicago, Illinois, 60612, United States
University of Kansas
Westwood, Kansas, 66205, United States
Tulane University Hospital & Clinics
New Orleans, Louisiana, 70112, United States
Ochsner Health System
New Orleans, Louisiana, 70121-2429, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Massachusetts General
Boston, Massachusetts, 02114, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
University Of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Washington University School Of Medicine
St Louis, Missouri, 63110-1032, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
NYU Langone Health
New York, New York, 10016, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte, North Carolina, 28204, United States
Novant Health 1
Charlotte, North Carolina, 28204, United States
Novant Health
Winston-Salem, North Carolina, 27103, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, 43210, United States
OhioHealth
Columbus, Ohio, 43214, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107-4215, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-8900, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Joe Arrington Cancer Research Treatment Center
Lubbock, Texas, 79410, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
UZ Brussel
Brussels, 1090, Belgium
UZA
Edegem, 2650, Belgium
Virga Jessa Ziekenhuis
Hasselt, 3500, Belgium
CHC MontLegia
Liège, 4000, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
UCL Mont Godinne
Yvoir, 5530, Belgium
Fundacao Pio XII
Barretos, 14784 400, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, 30150-221, Brazil
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
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
Florianópolis, 88034 000, Brazil
Liga Norte Riograndense Contra O Cancer
Natal, 59062-000, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, 90050-170, Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, 14051 140, 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
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
São Paulo, 01308 901, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia
São Paulo, 01321-001, Brazil
Hospital Paulistano
São Paulo, 01323-000, Brazil
Instituto D Or de Pesquisa e Ensino IDOR
São Paulo, 01401 002, Brazil
Clinica Sao Germano
São Paulo, 01455 010, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Peking Union Medical College Hospital
Beijing, 100006, China
Peking University First Hospital
Beijing, 100034, China
The First Hospital of Jilin University
Changchun, 130021, China
The second Xiangya Hospital of Central South University
Changsha, 410000, China
Beijing Chaoyang Hospital
Chaoyang District, 100020, China
Sichuan Academy of Medical Science Sichuan Provincial People's Hospital
Chengdu, 610072, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Guangdong Provincial People's Hospital
Guangzhou, 510080, China
Sun Yat Sen University Cancer Center
Guangzhou, 510710, China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, 310003, China
Nanjing Drum Tower Hospital
Nanjing, 210008, China
Tongji Hospital of Tongji University
Shanghai, 200065, China
Shanghai Fourth People s Hospital
Shanghai, 200434, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
First Affiliated Hospital SooChow University
Suzhou, 215006, China
Tianjin cancer hospital
Tianjin, 300060, China
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin, 300320, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, 430030, China
Henan Cancer Hospital
Zhengzhou, 450008, China
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Prague, 128 08, Czechia
APHP - Hopital Henri Mondor
Créteil, 94010, France
CHU Dijon
Dijon, 21000, France
Centre Leon Berard
Lyon, 69008, France
CHU de Montpellier - Hopital Saint-Eloi
Montpellier, 34295, France
CHU de Nantes hotel Dieu
Nantes, 44093, France
CHU HOPITAL DE L'ARCHET - Hematology
Nice, 06202, France
CHU Hopital Saint Antoine
Paris, 75571, France
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
Pessac, 33604, France
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse, 31059, France
Charite Campus Benjamin Franklin
Berlin, 12203, Germany
Universitaetsklinikum Koeln
Cologne, 50937, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Leipzig
Leipzig, 04103, Germany
Universitätsmedizin der Johannes Gutenberg Universität
Mainz, 55131, Germany
Universitaetsklinikum Wuerzburg
Würzburg, 97080, Germany
Alexandra General Hospital of Athens
Athens Attica, 115 28, Greece
Anticancer Hospital of Thessaloniki Theageneio
Thessaloniki, 546 39, Greece
G Papanikolaou Hospital of Thessaloniki
Thessalonikis, 570 10, Greece
Ha'Emek Medical Center
Afula, 1834111, Israel
Shamir Medical Center Assaf Harofeh
Be’er Ya‘aqov, 70300, Israel
Hillel Yaffe Medical Center
Hadera, 3810101, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rambam Medical Center
Haifa, 31096, Israel
Carmel Medical Center
Haifa, 34362, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Galilee Medical Center
Nahariya, 22100, Israel
Beilinson medical center
Petah Tikva, 49100, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Ziv Medical Center
Safed, 13100, Israel
Sourasky (Ichilov) Medical Center
Tel Aviv, 6423906, Israel
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona, 60126, Italy
Policlinico di Bari
Bari, 70124, Italy
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna, 40138, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, 95123, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Azienda Ospedaliera Universitaria di Padova
Padova, 35128, Italy
Ospedale Villa Sofia-Cervello
Palermo, 90146, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123, Italy
Presidio Ospedaliero Santo Spirito in Sassia
Roma, 00193, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
A.O.U. Città della Salute e della Scienza
Torino, 10126, Italy
Institute of Science Tokyo Hospital
Bunkyō City, 113 8519, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Ogaki Municipal Hospital
Gifu, 503-8502, Japan
Gunma University Hospital
Gunma, 371-0034, Japan
Kansai Medical University Hospital
Hirakata, 573 1191, Japan
Japanese Red Cross Society Himeji Hospital
Hyōgo, 670-8540, Japan
Shonan Kamakura General Hospital
Kamakura-shi, 247-8533, Japan
National Cancer Center Hospital East
Kashiwa, 277 8577, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, 343-8555, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kyoto Kuramaguchi Medical Center
Kyoto, 603-8151, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto, 399-8701, Japan
Niigata Cancer Center Hospital
Niigata, 951-8566, Japan
Hyogo Medical University Hospital
Nishinomiya Shi, 663 8501, Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Ōtake, 739-0696, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Tohoku University Hospital
Sendai, 980 8574, Japan
Iwate Medical University Hospital
Shiwa-gun, 028-3695, Japan
The University of Osaka Hospital
Suita, 565 0871, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550, Japan
Albert Schweitzer ziekenhuis-lokatie Dordwijk
Dordrecht, 3318 AT, Netherlands
Maxima Medisch Centrum
Eindhoven, 5631 BM, Netherlands
Erasmus MC
Rotterdam, 3015, Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, 36-200, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214, Poland
Pratia Onkologia Katowice
Katowice, 40 519, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce, 25 734, Poland
Szpital Uniwersytecki w Krakowie
Krakow, 30 688, Poland
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
Lublin, 20090, Poland
Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii
Olsztyn, 10-228, Poland
Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie
Szczecin, 71-252, Poland
Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
Torun, 87 100, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02-781, Poland
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
Wroclaw, 50 367, Poland
Dong-A University Hospital
Busan, 602 812, South Korea
National Cancer Center
Gyeonggi-do, 10408, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128, South Korea
Jeonbuk National University Hospital
Jeonju, 54907, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp. Univ. Virgen de La Arrixaca
El Palmar, 30120, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407, Spain
Hosp. de Leon
León, 24071, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp Univ Hm Sanchinarro
Madrid, 28050, Spain
Hosp Virgen de La Victoria
Málaga, 29010, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Hosp. Univ. de Canarias
San Cristóbal de La Laguna, 38320, Spain
Hosp. Univ. Dr. Peset
Valencia, 46017, Spain
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10048, Taiwan
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit
Ankara, 06200, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06590, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06680, Turkey (Türkiye)
Antalya Egitim ve Arastirma Hastanesi
Antalya, 07100, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Cerrahpasa Tip Fakultesi Prof. Dr. Murat Dilmener Hastanesi
Istanbul, 34153, Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, 34214, Turkey (Türkiye)
Dokuz Eylul University Medical Faculty
Izmir, 35330, Turkey (Türkiye)
Ondokuz Mayis University
Samsun, 55139, Turkey (Türkiye)
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
Ninewells Hospital & Medical School
Dundee, DD1 9SY, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Newcastle Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH, United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Links
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
June 22, 2022
First Posted
July 13, 2022
Study Start
October 13, 2022
Primary Completion (Estimated)
July 30, 2027
Study Completion (Estimated)
May 25, 2028
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