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NCT04923893Active, not recruitingPhase 3

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA Versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to compare the efficacy of Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by a single administration of ciltacabtagene autoleucel (cilta-cel) versus VRd induction followed by Lenalidomide and Dexamethasone (Rd) maintenance in newly diagnosed multiple myeloma participants for whom ASCT is not planned as initial therapy in terms of Progression Free Survival (PFS).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
743 (actual)
First submitted
10 Jun 2021
Start date
19 Aug 2021
Primary completion date
14 Feb 2029
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04923893
EU CT number
2023-505850-16-00
EudraCT number
2021-001242-35

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 743
  • From 19 Aug 2021 to the primary completion date, 14 Feb 2029
  • 128 sites in 26 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
  • Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd
  • Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
  • Any therapy that is targeted to B-cell maturation antigen (BCMA)

Other illness

  • Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5
  • Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
  • Seropositive for human immunodeficiency virus (HIV)
  • Hepatitis B infection
  • Hepatitis C infection

Other

  • Frailty index of \>=2 according to Myeloma Geriatric Assessment score
  • Participant must not require continuous supplemental oxygen

Who the study is looking for

  • Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable disease at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=)1.0 gram per deciliter (g/dL) or urine M-protein level \>=200 milligram (mg)/24 hours; or Light chain MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum immunoglobin (Ig) free light chain \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa/lambda FLC ratio
  • Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
  • Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment
  • A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.
  • Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (\>=) 8.0 g/dL (\>=5 millimoles per liter \[mmol/L\]), recombinant human erythropoietin use is permitted; platelets \>=75 \*10\^9/L; absolute lymphocyte count \>=0.3 \*10\^9/L; absolute neutrophil count (ANC) \>=1.0 ×10\^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (\<=) 3.0 \* upper limit of normal (ULN); estimated glomerular filtration rate \>=40 milliliter per minute/1.73 meter square (mL/min/1.73 m\^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin \<=2.0 \* ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin \<=2.0 \* ULN is required)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (128)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaUnknown status
Hospital Alemán
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Buenos AiresArgentinaUnknown status
Hospital Privado Universitario de Córdoba
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CórdobaArgentinaUnknown status
Ordensklinikum Linz GmbH
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LinzAustriaActive, not recruiting
SCRI CCCIT Ges.m.b.H.
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SalzburgAustriaActive, not recruiting
Medical University of Vienna
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ViennaAustriaActive, not recruiting
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
St Vincents Hospital Melbourne
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FitzroyAustraliaUnknown status
Austin Health
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HeidelbergAustraliaUnknown status
Royal Brisbane and Womens Hospital
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HerstonAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
Alfred Health
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MelbourneAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Calvary Mater Newcastle Hospital
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WaratahAustraliaUnknown status
Western Sydney Local Health District
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WestmeadAustraliaUnknown status
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumActive, not recruiting
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
IDOR - Regional Bahia
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SalvadorBrazilUnknown status
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São PauloBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
Juravinski Cancer Centre
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HamiltonCanadaUnknown status
Hôpital Maisonneuve-Rosemont
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MontrealCanadaUnknown status
Princess Margaret Cancer Centre - University Health Network
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TorontoCanadaUnknown status
Vancouver General Hospital
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VancouverCanadaUnknown status
Universitätsspital Basel
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BaselSwitzerlandUnknown status
Inselspital Universitätsspital Bern
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BernSwitzerlandUnknown status
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
Universitaet Leipzig
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LeipzigGermanyActive, not recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyActive, not recruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyActive, not recruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyActive, not recruiting
Universitaetsklinikum Tuebingen AöR
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TuebingenGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Aarhus Universitetshospital
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Aarhus NDenmarkActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Odense University Hospital
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Odense CDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
University Of Helsinki
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HelsinkiFinlandActive, not recruiting
Oulu University Hospital
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OuluFinlandActive, not recruiting
Turku University Hospital
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TurkuFinlandActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Hopital Saint Louis
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
University Hospitals Birmingham NHS Trust,
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BirminghamUnited KingdomUnknown status
Bristol Royal Infirmary
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BristolUnited KingdomUnknown status
Leeds Teaching Hospitals NHS Trust
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LeedsUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
University College Hospital
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LondonUnited KingdomUnknown status
Manchester Royal Infirmary
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ManchesterUnited KingdomUnknown status
The Royal Marsden NHS Trust Sutton
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SurreyUnited KingdomUnknown status
General Hospital of Athens - Alexandra
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AthensGreeceActive, not recruiting
University General Hospital Attikon
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AthensGreeceActive, not recruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceActive, not recruiting
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
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Budapest IXHungaryActive, not recruiting
St James's Hospital
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Dublin 8IrelandActive, not recruiting
Hadassah University Hospita Ein Kerem
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JerusalemIsraelUnknown status
Sheba Medical Center, Tel Hashomer
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Juntendo University Hospital
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Bunkyō CityJapanUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
Hyogo Medical University Hospital
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HyōgoJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
Hokkaido University Hospital
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SapporoJapanUnknown status
Tohoku University Hospital
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SendaiJapanUnknown status
Japanese Red Cross Medical Center
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Shibuya CityJapanUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Stichting Radboud Universitair Medisch Centrum
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NijmegenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandActive, not recruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Instytut Hematologii I Transfuzjologii
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WarsawPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandActive, not recruiting
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
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LisbonPortugalActive, not recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalActive, not recruiting
Linkoping University Hospital Region Ostergotland
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LinkopingSwedenActive, not recruiting
Region Skane Skanes Universitetssjukhus
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LundSwedenActive, not recruiting
University of Maryland Medical Center
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BaltimoreUnited StatesUnknown status
Beth Israel Deaconess Medical Center
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BostonUnited StatesUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Barbara Ann Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Henry Ford Cancer Institute
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DetroitUnited StatesUnknown status
University of Iowa Hospitals and Clinics
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Iowa CityUnited StatesUnknown status
University of Kentucky
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LexingtonUnited StatesUnknown status
Norton Cancer Institute
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LouisvilleUnited StatesUnknown status
University of Miami Health System
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MiamiUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
Yale Cancer Center
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New HavenUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesUnknown status
New York Presbyterian-Weill Cornell Medical College
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New YorkUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
AdventHealth Cancer Institute
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OrlandoUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh Medical Center
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PittsburghUnited StatesUnknown status
UCSF
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San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.