Clinical trial NCT03301220: A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
Official title: A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Smoldering Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-10-04
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of high risk smoldering multiple myeloma (SMM) (per International Myeloma Working Group \[IMWG\] criteria) for less than or equal to (\<=) 5 years with measurable disease at the time of randomization, defined as serum M protein greater than or equal to (\>=) 10 gram per liter (g/L) or urine M protein \>= 200 milligram per 24 hours (mg/24 hours) or involved serum free light chain (FLC) \>=100 milligram per liter (mg/L) and abnormal serum FLC ratio
* Clonal bone marrow plasma cells (BMPCs) \>= 10 percentage (%); and at least 1 of the following risk factors; Serum M protein \>= 30 g/L, immunoglobulin (Ig)A SMM, immunoparesis with reduction of 2 uninvolved immunoglobulin isotypes (only IgA, IgM, and IgG should be considered in determination for immunoparesis; IgD and IgE are not considered in this assessment), serum involved: uninvolved FLC ratio \>= 8 and less than (\<) 100, or clonal BMPCs greater than (\>) 50% to \<60% with measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use highly effective method of contraception
* A woman of childbearing potential must have a negative serum or urine pregnancy test at screening within 14 days prior to randomization
* During the study and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction

Exclusion Criteria:

* Multiple myeloma (MM), requiring treatment, defined by any of the following:

  1. Bone lesions (1 or more osteolytic lesions on low-dose whole body computed tomography \[LDCT\], positron-emission tomography with computed tomography \[PET-CT\] or CT). Participants who have benign/post-traumatic bone lesions visible on screening images as well as previous imaging, may be considered for inclusion. Details (diagnosis, location, duration) on benign/post-traumatic pre-existing bone lesions that can be seen on the screening images (example \[eg.\], old fractures) and were also present on previous imaging are to be reported in the case report form (CRF)
  2. Hypercalcemia (serum calcium greater than \[\>\]0.25 millimoles per liter \[mmol/L\] \[\>1 milligram per deciliter {mg/dL}\] higher than upper limit of normal \[ULN\] or \>2.75 mmol/L \[\>11 mg/dL\]). Participants who have clinically stable hypercalcemia attributable to a disease other than multiple myeloma (eg, hyperparathyroidism) may be considered for inclusion after a case by case review by the medical monitor
  3. Renal insufficiency, preferably determined by creatinine clearance less than (\<)40 milliliter per minute (mL/min) measured or estimated using the Modification of Diet in Renal Disease (MDRD), or serum creatinine \>177 micromole per liter (μmol/L). Participants who have clinically stable renal insufficiency attributable to a disease other than multiple myeloma (eg, glomerulonephritis) may be considered for inclusion after a case by case review by the medical monitor
  4. Anemia, defined as hemoglobin \<10 gram per deciliter (g/dL) or \>2 g/dL below lower limit of normal or both; transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted. Participants who have clinically stable anemia attributable to a disease other than multiple myeloma (eg, thalassemia, vitamin B12 deficiency, iron deficiency) may be considered for inclusion after a case by case review by the medical monitor
  5. Clonal BMPC percentage \>=60%
  6. Serum FLC ratio (involved:uninvolved) \>=100 (the involved FLC must be \>=100 mg/L)
  7. More than 1 focal lesion \>=5 millimeter (mm) in diameter by magnetic resonance imaging (MRI)
* Primary systemic amyloid light-chain (AL) (immunoglobulin light chain) amyloidosis
* Exposure to any of the following:

  1. Prior exposure to daratumumab or prior exposure to other anti-Cluster of Differentiation 38 (anti-CD38) therapies
  2. Prior exposure to approved or investigational treatments for SMM or MM (including but not limited to conventional chemotherapies, immunomodulatory agent \[IMiDs\], or proteasome inhibitor \[PIs\]). Stable standard dosing of bisphosphonate and denosumab as indicated for osteoporosis is acceptable
  3. Exposure to investigational drug (including investigational vaccines) or invasive investigational medical device for any indication within 4 weeks or 5 half-lives, whichever is longer, before Cycle 1, Day 1
  4. Ongoing treatment with corticosteroids with a dose \>10 milligram (mg) prednisone or equivalent per day at the time of randomization; or \>280 mg cumulative prednisone dose or equivalent for any 4-week period in the year prior to randomization
  5. Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab), immunomodulators (eg, abatacept, methotrexate, azathioprine, cyclosporine) or other treatments that are likely to interfere with the study procedures or results
* Received treatment (chemotherapy, surgery, et cetera \[etc\]) for a malignancy (other than SMM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion), which is considered cured with minimal risk of recurrence within 3 years
* Medical or psychiatric condition or disease (for example, active systemic disease \[including presence of auto-antibodies\], uncontrolled diabetes) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
* Known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies, hyaluronidase, or other human proteins, or their excipients, or known sensitivity to mammalian-derived products (including dairy allergy)

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From the date of randomization to active multiple myeloma (MM) or the date of death, whichever occurs first (up to approximately 8 years)
Secondary outcomes:
measure: Time to Biochemical or Diagnostic (SLiM-CRAB) Progression
timeFrame: Up to biochemical or diagnostic progression (up to approximately 8 years)
measure: Overall Response Rate (ORR)
timeFrame: Up to approximately 8 years
measure: Complete Response (CR) Rate
timeFrame: Up to approximately 8 years
measure: Time to First-Line Treatment for Multiple Myeloma (MM)
timeFrame: Post-progressive disease (PD) follow-up, every 6 months until end of study (up to approximately 8 years)
measure: Progression-Free Survival on First-Line Treatment for MM (PFS2)
timeFrame: Post-PD follow-up, every 6 months until end of study (up to approximately 8 years)
measure: Overall Survival (OS)
timeFrame: Throughout study, and at least every 3 months until PD; post-PD, every 6 months until end of study (up to approximately 8 years)
measure: Percentage of Participants who Progress to MM With Adverse Prognostic Features
timeFrame: At screening and PD (up to approximately 8 years)
measure: Serum Daratumumab Pharmacokinetic (PK) Concentration
timeFrame: Cycles 1 and 3: Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT: 28 days after the last daratumumab dose); and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
measure: Maximum Observed Concentration (Cmax) of Daratumumab
timeFrame: Cycles 1 and 3: Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT: 28 days after the last daratumumab dose); and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
measure: Minimum Observed Concentration (Cmin) of Daratumumab
timeFrame: Cycles 1 and 3: Day 1 predose, and Day 4 postdose; Cycles 5, 7, 12, and 24: Day 1 predose; end of the treatment (EOT: 28 days after the last daratumumab dose); and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
measure: Number of Participants With Anti-daratumumab Antibodies
timeFrame: Cycles 1,3,5,7,12, and 24: Predose on Day 1; end of treatment (28 days after the last daratumumab dose), and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
measure: Number of Participants With Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies
timeFrame: Cycles 1,3,5,7,12, and 24: Predose on Day 1; end of treatment (28 days after the last daratumumab dose), and 8 weeks after the last daratumumab dose (up to approximately 3 years and 8 weeks)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
timeFrame: Baseline, Weeks 12, 24, and 60, every year until end of treatment (EOT)/active monitoring, pre-PD follow-up (every year until end of study or PD), PD, and Months 3, 6, 12, and 18 post-PD (up to approximately 8 years)
measure: Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
timeFrame: Baseline, Weeks 12, 24, and 60, every year until end of treatment (EOT)/active monitoring, pre-PD follow-up (every year until end of study or PD), PD, and Months 3, 6, 12, and 18 post-PD (up to approximately 8 years)
measure: Change From Baseline in European Quality (EuroQoL) 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire
timeFrame: Baseline, Weeks 12, 24, and 60, every year until end of treatment (EOT)/active monitoring, pre-PD follow-up (every year until end of study or PD), PD, and Months 3, 6, 12, and 18 post-PD (up to approximately 8 years)
measure: Duration of Response
timeFrame: From the date of initial documentation of a response to the date of first documented evidence of PD (up to approximately 8 years)
measure: Time to Response
timeFrame: Up to End of Treatment (up to approximately 39 cycles [each cycle of 28 days] or 36 months, whichever occurs first)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Associates, PC - HAL
state: Arizona
city: Whittier
country: United States
facility: Innovative Clinical Research Inc
state: California
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Metairie
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: North Las Vegas
country: United States
facility: VA Southern Nevada Healthcare
state: Nevada
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute, Carolinas HealthCare System
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: OHSU/CHM
state: Oregon
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Austin
country: United States
facility: Texas Oncology P A
state: Texas
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Tyler
country: United States
facility: Texas Oncology P A
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Buenos Aires
country: Argentina
facility: Hospital Aleman
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: CEMIC Saavedra
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
city: Rosario
country: Argentina
facility: Sanatorio Britanico de Rosario
city: Heidelberg
country: Australia
facility: Austin Hospital
city: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
city: West Perth
country: Australia
facility: The Perth Blood Institute
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
city: Antwerpen
country: Belgium
facility: ZNA
city: Brugge
country: Belgium
facility: AZ St.-Jan Brugge-Oostende AV
city: Brussel
country: Belgium
facility: UZBrussel
city: Gent
country: Belgium
facility: UZ Gent
city: Hasselt
country: Belgium
facility: Virga Jessa Ziekenhuis
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Florianopolis
country: Brazil
facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN
city: Goiania
country: Brazil
facility: Universidade Federal de Goias - Hospital das Clinicas da UFG
city: Joinville
country: Brazil
facility: Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Rio de Janeiro
country: Brazil
facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa São Lucas
city: São Paulo
country: Brazil
facility: Clinica Sao Germano
city: São Paulo
country: Brazil
facility: Hospital Santa Cruz
city: Calgary
country: Canada
facility: Arthur J E Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Oshawa
country: Canada
facility: Lakeridge Health Oshawa
state: Ontario
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
city: Aarhus N.
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense C
country: Denmark
facility: Odense Universitetshospital
city: Ålborg
country: Denmark
facility: Ålborg Universitetshospital
city: Limoges
country: France
facility: CHU de Limoges - Fédération Hépatologie
city: Nantes cedex 01
country: France
facility: Chu Hotel Dieu
city: Pessac cedex
country: France
facility: CHU de Bordeaux - Hospital Haut-Leveque
city: Pierre Benite cedex
country: France
facility: Centre hospitalier Lyon-Sud
city: Poitiers
country: France
facility: CHU De Poitiers
city: Rennes
country: France
facility: l'Hôpital Pontchaillou
city: Tours Cedex 9
country: France
facility: CHU Bretonneau
city: Berlin
country: Germany
facility: Helios Kliniken Berlin Buch Gmbh
city: Hamm
country: Germany
facility: St. Barbara-Klinik Hamm GmbH
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg Medizinische Klinik V
city: Muenster
country: Germany
facility: Medizinische Klinik A
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
city: Athens Attica
country: Greece
facility: Alexandra General Hospital of Athens
city: Budapest N/a
country: Hungary
facility: Semmelweis Egyetem, I. Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Semmelweis Egyetem I.Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Del Pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet Szent Laszlo Telephely
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Afula
country: Israel
facility: Haemek
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petah-Tiqva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola Malpighi
city: Cagliari
country: Italy
facility: Businco Cancer Hospital
city: Cuneo
country: Italy
facility: A.O. Santa Croce e Carle
city: Roma
country: Italy
facility: Ospedale S. Eugenio
city: Roma
country: Italy
facility: Università di Roma 'La Sapienza' - Ospedale Umberto 1°
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino- Divisione di Ematologia
city: Varese
country: Italy
facility: ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital
city: Gifu
country: Japan
facility: Ogaki Municipal Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kawachi Nagano
country: Japan
facility: National Hospital Organization Osaka Minami Medical Center
city: Kobe City
country: Japan
facility: Kobe City Medical Center General Hospital
city: Kumamoto shi
country: Japan
facility: National Hospital Organization Kumamoto Medical Center
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kyoto
country: Japan
facility: Kyoto Kuramaguchi Medical Center
city: Matsumoto
country: Japan
facility: National Hospital Organization Matsumoto Medical Center
city: Matsuyama
country: Japan
facility: Matsuyama Red Cross Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Sendai-City
country: Japan
facility: National Hospital Organization Sendai Medical Center
city: Shibukawa
country: Japan
facility: National Hospital Organization Shibukawa Medical Center
city: Shibuya
country: Japan
facility: Japanese Red Cross Medical Center
city: Aguascalientes
country: Mexico
facility: iBiomed Research Unit
city: Cuernavaca
country: Mexico
facility: JM Research, SC
city: Guadalajara
country: Mexico
facility: Centro de Investigación Farmacéutica Especializada
city: Merida
country: Mexico
facility: Centro de Atención e Investigación Clínica en Oncología
city: Monterrey
country: Mexico
facility: Hospital Universitario de Nuevo León
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis
city: Den Haag
country: Netherlands
facility: Haga ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Tilburg
country: Netherlands
facility: ETZ TweeSteden
city: Oslo
country: Norway
facility: Oslo University Hospital HF Ulleval sykehus
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
city: Legnica
country: Poland
facility: Wojewodzki Szpital Specjalistyczny w Legnicy
city: Poznan
country: Poland
facility: Clinical Research Center Sp z o o Medic R Sp k
city: Warszawa
country: Poland
facility: Instytut Hematologii i Transfuzjologii
city: Dzerzhinsk
country: Russian Federation
facility: Emergency Hospital of Dzerzhinsk
city: Moscow
country: Russian Federation
facility: City clinical hospital n.a. S.P.Botkin
city: Moscow
country: Russian Federation
facility: City Clinical Hospital # 40
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Region Clinical Hospital
city: Perm
country: Russian Federation
facility: Perm Medical Sanitary Unit#1
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital n.a.V.A.Baranov
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: St-Petersburg
country: Russian Federation
facility: Clinical Research Institute of Hematology and Transfusiology
city: Syktyvkar
country: Russian Federation
facility: Oncology Dispensary of Komi Republic
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Pamplona
country: Spain
facility: Clinica Univ. de Navarra
city: Pozuelo de Alarcon
country: Spain
facility: Hosp. Quiron Madrid Pozuelo
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Valencia
country: Spain
facility: Hosp. Univ. Dr. Peset
city: Falun
country: Sweden
facility: Falu Lasarett
city: Luelå
country: Sweden
facility: Sunderby Sjukhus Medicinkliniken
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge
city: Ankara
country: Turkey
facility: Ankara Numune Egitim ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Edirne
country: Turkey
facility: Trakya University Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Kayseri
country: Turkey
facility: Erciyes University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Trust
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Stoke-On-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: