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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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)

    Exclusion Criteria:

    - Frailty index of >=2 according to Myeloma Geriatric Assessment score.
  • - 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.
  • - Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM.
  • - Stroke or seizure within 6 months of signing Informed Consent Form (ICF) - Seropositive for human immunodeficiency virus (HIV) - Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd.
  • - Participant must not require continuous supplemental oxygen.
  • - Hepatitis B infection.
  • - Hepatitis C infection.
  • - 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04923893
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function. JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The primary hypothesis of this study is that in participants with newly diagnosed MM, treatment with VRd induction followed by a single administration of cilta-cel will significantly improve progression free survival compared to Bortezomib, Lenalidomide and Dexamethasone (VRd) induction followed by Rd maintenance. The study will screen participants with newly diagnosed MM who are not planned to receive autologous stem cell transplant (ASCT) as initial therapy. This study will be conducted in 4 phases: Screening (up to 28 days), Pre-randomization Treatment, Treatment, and Follow-up. Assessments like patient-reported outcome(s) (PROs), electrocardiogram (ECG), vital signs and pharmacokinetics will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, assessment of cardiac function, Immune-Effector Cell-Associated Encephalopathy (ICE) and handwriting assessments (only for Arm B) and Eastern Cooperative Oncology Group (ECOG) performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 12 years 5 months.

Arms & Interventions

Arms

Experimental: Arm A: VRd+Rd (Standard Therapy)

Participants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization. Following randomization, participants in Arm A will receive 2 more cycles of VRd. In VRd treatment, participants will receive bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to 8) and oral dexamethasone 25 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle (Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle will consist of 28 days. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity.

Experimental: Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)

Participants will receive VRd regimen for 6 cycles before randomization. Following randomization, participants in Arm B will undergo apheresis and receive two more cycles of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3 mg/m^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen (cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3 days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg).

Interventions

Drug: - Bortezomib

Bortezomib will be administered SC.

Drug: - Dexamethasone

Dexamethasone will be administered orally.

Drug: - Lenalidomide

Lenalidomide will be administered orally.

Drug: - Cilta-cel

Cilta-cel infusion will be administered.

Drug: - Cyclophosphamide

Cyclophosphamide will be administered intravenously.

Drug: - Fludarabine

Fludarabine will be administered intravenously.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF, San Francisco, California

Status

Not yet recruiting

Address

UCSF

San Francisco, California, 94143

Stanford University Medical Center, Stanford, California

Status

Withdrawn

Address

Stanford University Medical Center

Stanford, California, 94305-5623

Yale Cancer Center, New Haven, Connecticut

Status

Not yet recruiting

Address

Yale Cancer Center

New Haven, Connecticut, 06510

University of Miami Health System, Miami, Florida

Status

Not yet recruiting

Address

University of Miami Health System

Miami, Florida, 33136

AdventHealth Cancer Institute, Orlando, Florida

Status

Not yet recruiting

Address

AdventHealth Cancer Institute

Orlando, Florida, 32832

University of Iowa Hospitals & Clinics, Iowa City, Iowa

Status

Not yet recruiting

Address

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242

University of Kansas Medical Center, Westwood, Kansas

Status

Not yet recruiting

Address

University of Kansas Medical Center

Westwood, Kansas, 66205

University of Kentucky, Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky

Lexington, Kentucky, 40536-0293

Norton Cancer Institute, Louisville, Kentucky

Status

Recruiting

Address

Norton Cancer Institute

Louisville, Kentucky, 40207

University Of Maryland Medical Center, Baltimore, Maryland

Status

Not yet recruiting

Address

University Of Maryland Medical Center

Baltimore, Maryland, 21201-1595

Boston, Massachusetts

Status

Not yet recruiting

Address

Harvard Medical School-Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215-5450

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Withdrawn

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Massachusetts General Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02215

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan

Status

Not yet recruiting

Address

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201

Henry Ford Cancer Institute, Detroit, Michigan

Status

Not yet recruiting

Address

Henry Ford Cancer Institute

Detroit, Michigan, 48202-2608

Mayo Clinic - Rochester, Rochester, Minnesota

Status

Withdrawn

Address

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

Columbia University Medical Center, New York, New York

Status

Not yet recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Not yet recruiting

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065

University of North Carolina, Chapel Hill, North Carolina

Status

Not yet recruiting

Address

University of North Carolina

Chapel Hill, North Carolina, 27599

Levine Cancer Institute, Charlotte, North Carolina

Status

Not yet recruiting

Address

Levine Cancer Institute

Charlotte, North Carolina, 28204

Thomas Jefferson University, Philadelphia, Pennsylvania

Status

Not yet recruiting

Address

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

Dallas, Texas

Status

Withdrawn

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8562

University of Virginia, Charlottesville, Virginia

Status

Not yet recruiting

Address

University of Virginia

Charlottesville, Virginia, 22903

Medical College Of Wisconsin, Milwaukee, Wisconsin

Status

Not yet recruiting

Address

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226

International Sites

Hospital Aleman, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Hospital Aleman

Buenos Aires, , C1118AAT

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

Status

Not yet recruiting

Address

Hospital Italiano de Buenos Aires

Buenos Aires, , C1199ABD

Cordoba, Argentina

Status

Not yet recruiting

Address

Hospital Privado Universitario de Córdoba

Cordoba, , 5016

Hospital Universitario Austral, Pilar, Argentina

Status

Not yet recruiting

Address

Hospital Universitario Austral

Pilar, , 1629

Royal Prince Alfred Hospital, Camperdown, Australia

Status

Recruiting

Address

Royal Prince Alfred Hospital

Camperdown, , 2050

St. Vincent's Hospital Melbourne, Fitzroy, Australia

Status

Recruiting

Address

St. Vincent's Hospital Melbourne

Fitzroy, , 3065

Austin Health, Heidelberg, Australia

Status

Recruiting

Address

Austin Health

Heidelberg, , 3084

Royal Brisbane and Womens Hospital, Herston, Australia

Status

Recruiting

Address

Royal Brisbane and Womens Hospital

Herston, , 4029

Alfred Health, Melbourne, Australia

Status

Recruiting

Address

Alfred Health

Melbourne, , 3004

Peter MacCallum Cancer Centre, Melbourne, Australia

Status

Recruiting

Address

Peter MacCallum Cancer Centre

Melbourne, , 8006

Fiona Stanley Hospital, Murdoch, Australia

Status

Recruiting

Address

Fiona Stanley Hospital

Murdoch, , 6150

Calvary Mater Newcastle Hospital, Waratah, Australia

Status

Recruiting

Address

Calvary Mater Newcastle Hospital

Waratah, , 2298

Western Sydney Local Health District, Westmead, Australia

Status

Recruiting

Address

Western Sydney Local Health District

Westmead, , 2145

Graz, Austria

Status

Not yet recruiting

Address

Medizinische Universität Graz, LKH-Univ.Klinikum Graz, Klinische Abteilung für Hämatologie

Graz, , 8036

Krankenhaus der Elisabethinen Linz, Linz, Austria

Status

Not yet recruiting

Address

Krankenhaus der Elisabethinen Linz

Linz, , 4020

Salzburg, Austria

Status

Not yet recruiting

Address

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, , 5020

Vienna, Austria

Status

Not yet recruiting

Address

Medical University of Vienna,Universitätsklinik für Innere Medizin I

Vienna, , 1090

Universitair Ziekenhuis - Antwerpen, Antwerp, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis - Antwerpen

Antwerp, , 2650

AZ St.-Jan Brugge-Oostende AV, Brugge, Belgium

Status

Recruiting

Address

AZ St.-Jan Brugge-Oostende AV

Brugge, , 8000

Cliniques Universitaires St-Luc, Brussel, Belgium

Status

Not yet recruiting

Address

Cliniques Universitaires St-Luc

Brussel, , 1200

UZ Gent, Gent, Belgium

Status

Recruiting

Address

UZ Gent

Gent, , 9000

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

Liege, Belgium

Status

Recruiting

Address

Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman

Liege, , B-4000

Hospital Sao Rafael, Salvador, Brazil

Status

Recruiting

Address

Hospital Sao Rafael

Salvador, , 41253-190

Ac Camargo Cancer Center, São Paulo, Brazil

Status

Recruiting

Address

Ac Camargo Cancer Center

São Paulo, , 01509-010

Hospital Israelita Albert Einstein, São Paulo, Brazil

Status

Recruiting

Address

Hospital Israelita Albert Einstein

São Paulo, , 05652-900

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Status

Recruiting

Address

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2

Juravinski Cancer Centre, Hamilton, Ontario, Canada

Status

Recruiting

Address

Juravinski Cancer Centre

Hamilton, Ontario, L8V5C2

Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, M5G2M9

Hopital Maisonneuve-Rosemont, Montréal, Quebec, Canada

Status

Not yet recruiting

Address

Hopital Maisonneuve-Rosemont

Montréal, Quebec, H1T 2M4

Vancouver General Hospital, Vancouver, Canada

Status

Recruiting

Address

Vancouver General Hospital

Vancouver, , V5Z 1M9

Fakultni nemocnice Brno, Brno, Czechia

Status

Recruiting

Address

Fakultni nemocnice Brno

Brno, , 625 00

Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czechia

Status

Recruiting

Address

Fakultni nemocnice Hradec Kralove

Hradec Kralove, , 500 05

Fakultni nemocnice Ostrava, Ostrava, Czechia

Status

Recruiting

Address

Fakultni nemocnice Ostrava

Ostrava, , 70852

Fakultni nemocnice Plzen, Plzen-Lochotin, Czechia

Status

Withdrawn

Address

Fakultni nemocnice Plzen

Plzen-Lochotin, , 304 60

Vseobecna fakultni nemocnice v Praze, Praha 2, Czechia

Status

Not yet recruiting

Address

Vseobecna fakultni nemocnice v Praze

Praha 2, , 128 08

Aarhus University Hospital, Aarhus C, Denmark

Status

Not yet recruiting

Address

Aarhus University Hospital

Aarhus C, , 8000

Rigshospitalet, Copenhagen, Denmark

Status

Recruiting

Address

Rigshospitalet

Copenhagen, , 2100

Odense Universitetshospital, Odense C, Denmark

Status

Not yet recruiting

Address

Odense Universitetshospital

Odense C, , 5000

Helsinki University Hospital, Helsinki, Finland

Status

Not yet recruiting

Address

Helsinki University Hospital

Helsinki, , 00029 HUS

Oulu University Hospital, Oulu, Finland

Status

Recruiting

Address

Oulu University Hospital

Oulu, , 90220

Turku University Hospital, Turku, Finland

Status

Not yet recruiting

Address

Turku University Hospital

Turku, , 20520

Lille Cedex, France

Status

Not yet recruiting

Address

Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

Lille Cedex, , 59000

C.H.U. Hotel Dieu - France, Nantes, France

Status

Not yet recruiting

Address

C.H.U. Hotel Dieu - France

Nantes, , 44093

Hopital Saint-Louis, Paris cedex 10, France

Status

Not yet recruiting

Address

Hopital Saint-Louis

Paris cedex 10, , 75475

CHU Poitiers - Hôpital la Milétrie, Poitiers, France

Status

Not yet recruiting

Address

CHU Poitiers - Hôpital la Milétrie

Poitiers, , 86021

Toulouse cedex 9, France

Status

Not yet recruiting

Address

Institut Universitaire du cancer de Toulouse-Oncopole

Toulouse cedex 9, , 31059

Berlin, Germany

Status

Not yet recruiting

Address

Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin

Berlin, , 12203

Dresden, Germany

Status

Recruiting

Address

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, , 01307

Universitatsklinikum Freiburg, Freiburg, Germany

Status

Not yet recruiting

Address

Universitatsklinikum Freiburg

Freiburg, , 79106

Universitaetsklinikum Hamburg Eppendorf, Hamburg, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Hamburg Eppendorf

Hamburg, , 20246

Medizinische Hochschule Hannover, Hannover, Germany

Status

Withdrawn

Address

Medizinische Hochschule Hannover

Hannover, , 30625

Universitaetsklinikum Heidelberg, Heidelberg, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Heidelberg

Heidelberg, , 69120

Universitatsklinikum Leipzig, Leipzig, Germany

Status

Recruiting

Address

Universitatsklinikum Leipzig

Leipzig, , 04103

Mainz, Germany

Status

Not yet recruiting

Address

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, , 55131

Tübingen, Germany

Status

Recruiting

Address

Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

Tübingen, , 72076

Universitätsklinikum Würzburg, Würzburg, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Würzburg

Würzburg, , 97080

Athens, Greece

Status

Recruiting

Address

Attikon University General Hospital of Attica

Athens, , 12462

G.Papanikolaou, Thessaloniki, Greece

Status

Recruiting

Address

G.Papanikolaou

Thessaloniki, , 57010

Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary

Status

Not yet recruiting

Address

Debreceni Egyetem Klinikai Kozpont

Debrecen, , 4032

St James's Hospital, Dublin, Ireland

Status

Not yet recruiting

Address

St James's Hospital

Dublin, , D08 NHY1

Hadassah University Hospita - Ein Kerem, Jerusalem, Israel

Status

Recruiting

Address

Hadassah University Hospita - Ein Kerem

Jerusalem, , P.O.B. 12000

Sheba Medical Center Tel Hashomer, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center Tel Hashomer

Ramat Gan, , 52621

Tel Aviv Sourasky Medical Center, Tel Aviv, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center

Tel Aviv, , 64239

Ancona, Italy

Status

Not yet recruiting

Address

A.O. Universitaria Ospedali Riuniti di Ancona

Ancona, , 60020

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, , 24127

Policlinico Sant'Orsola Malpighi, Bologna, Italy

Status

Not yet recruiting

Address

Policlinico Sant'Orsola Malpighi

Bologna, , 40138

Genova, Italy

Status

Not yet recruiting

Address

IRCCS Azienda Ospedaliera San Martino - IST

Genova, , 16132

Milano, Italy

Status

Not yet recruiting

Address

Fondazione IRCCS Istituto Nazionale dei Tumori

Milano, , 20133

Milano, Italy

Status

Not yet recruiting

Address

ASST Grande Ospedale Metropolitano Niguarda

Milano, , 20162

Casa di Cura La Maddalena, Palermo, Italy

Status

Not yet recruiting

Address

Casa di Cura La Maddalena

Palermo, , 90146

Reggio Calabria, Italy

Status

Not yet recruiting

Address

Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

Reggio Calabria, , 89133

AOU Policlinico Umberto I, Roma, Italy

Status

Not yet recruiting

Address

AOU Policlinico Umberto I

Roma, , 00161

Verona, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria Integrata Verona

Verona, , 37134

Kyushu University Hospital, Fukuoka, Japan

Status

Recruiting

Address

Kyushu University Hospital

Fukuoka, , 812-8582

Kanazawa University Hospital, Kanazawa, Japan

Status

Recruiting

Address

Kanazawa University Hospital

Kanazawa, , 920-8641

Kyoto, Japan

Status

Recruiting

Address

University Hospital Kyoto Perfectural University of Medicine

Kyoto, , 602-8566

Nagoya City University Hospital, Nagoya, Japan

Status

Recruiting

Address

Nagoya City University Hospital

Nagoya, , 467-8602

Okayama University Hospital, Okayama, Japan

Status

Recruiting

Address

Okayama University Hospital

Okayama, , 700-8558

Hokkaido University Hospital, Sapporo, Japan

Status

Recruiting

Address

Hokkaido University Hospital

Sapporo, , 060-8648

Tohoku University Hospital, Sendai, Japan

Status

Recruiting

Address

Tohoku University Hospital

Sendai, , 980-8574

Japanese Red Cross Medical Center, Shibuya, Japan

Status

Recruiting

Address

Japanese Red Cross Medical Center

Shibuya, , 150-8935

Hwasun Gun, Korea, Republic of

Status

Recruiting

Address

Chonnam National University Hwasun Hospital

Hwasun Gun, , 58128

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital, Yonsei University Health System

Seoul, , 03722

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 05505

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, , 06591

VU Medisch Centrum, Amsterdam, Netherlands

Status

Not yet recruiting

Address

VU Medisch Centrum

Amsterdam, , 1081 HV

University Medical Center Groningen, Groningen, Netherlands

Status

Recruiting

Address

University Medical Center Groningen

Groningen, , 9713 GZ

UMC Radboud, Nijmegen, Netherlands

Status

Not yet recruiting

Address

UMC Radboud

Nijmegen, , 6500 HB

Erasmus MC, Rotterdam, Netherlands

Status

Not yet recruiting

Address

Erasmus MC

Rotterdam, , 3075 EA

Oslo, Norway

Status

Recruiting

Address

Oslo universitetssykehus HF, Rikshospitalet

Oslo, , 0372

Uniwersyteckie Centrum Kliniczne, Gdansk, Poland

Status

Recruiting

Address

Uniwersyteckie Centrum Kliniczne

Gdansk, , 80-214

Gliwice, Poland

Status

Recruiting

Address

Narodowy Instytut Onkologii im.Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz. w Gliwicach

Gliwice, , 44102

Lublin, Poland

Status

Not yet recruiting

Address

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

Lublin, , 20-090

Poznań, Poland

Status

Recruiting

Address

Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu

Poznań, , 60-569

Instytut Hematologii i Transfuzjologii, Warszawa, Poland

Status

Recruiting

Address

Instytut Hematologii i Transfuzjologii

Warszawa, , 02-776

Wroclaw, Poland

Status

Not yet recruiting

Address

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, , 50-367

Instituto Portugues de Oncologia, Lisboa, Portugal

Status

Not yet recruiting

Address

Instituto Portugues de Oncologia

Lisboa, , 1099-023

Hospital De Santa Maria, Lisboa, Portugal

Status

Not yet recruiting

Address

Hospital De Santa Maria

Lisboa, , 1649-035

Instituto Portugues de Oncologia, Porto, Portugal

Status

Not yet recruiting

Address

Instituto Portugues de Oncologia

Porto, , 4200072

Hosp. de La Santa Creu I Sant Pau, Barcelona, Spain

Status

Recruiting

Address

Hosp. de La Santa Creu I Sant Pau

Barcelona, , 08041

Hosp. Univ. Vall D Hebron, Barcelona, Spain

Status

Recruiting

Address

Hosp. Univ. Vall D Hebron

Barcelona, , 8035

L'Hospitalet de Llobregat, Spain

Status

Recruiting

Address

Instituto Catalan Deoncologia Hospital Duran I Reynals

L'Hospitalet de Llobregat, , 08908

Hosp. Gral. Univ. Gregorio Marañon, Madrid, Spain

Status

Recruiting

Address

Hosp. Gral. Univ. Gregorio Marañon

Madrid, , 28007

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

Hosp. Univ. Virgen de La Arrixaca, Murcia, Spain

Status

Recruiting

Address

Hosp. Univ. Virgen de La Arrixaca

Murcia, , 30120

Clinica Univ. de Navarra, Pamplona, Spain

Status

Recruiting

Address

Clinica Univ. de Navarra

Pamplona, , 31008

Hosp. Clinico Univ. de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Salamanca

Salamanca, , 37007

Hosp. Univ. Marques de Valdecilla, Santander, Spain

Status

Recruiting

Address

Hosp. Univ. Marques de Valdecilla

Santander, , 39008

Hosp. Virgen Del Rocio, Sevilla, Spain

Status

Recruiting

Address

Hosp. Virgen Del Rocio

Sevilla, , 41013

Hosp. Univ. I Politecni La Fe, Valencia, Spain

Status

Recruiting

Address

Hosp. Univ. I Politecni La Fe

Valencia, , 46026

Sahlgrenska University Hospital, Göteborg, Sweden

Status

Recruiting

Address

Sahlgrenska University Hospital

Göteborg, , 413 45

Universitetssjukhuset, Linköping, Sweden

Status

Recruiting

Address

Universitetssjukhuset

Linköping, , 58185

Skane University Hospital, Lund, Sweden

Status

Recruiting

Address

Skane University Hospital

Lund, , 221 85

Haematology Centre, R 51, Stockholm, Sweden

Status

Withdrawn

Address

Haematology Centre, R 51

Stockholm, , SE-141 86

Akademiska Sjukhuset, Uppsala, Sweden

Status

Withdrawn

Address

Akademiska Sjukhuset

Uppsala, , 751 85

Universitatsspital Basel, Basel, Switzerland

Status

Not yet recruiting

Address

Universitatsspital Basel

Basel, , 4031

INSELSPITAL, Universitätsspital Bern, Bern, Switzerland

Status

Not yet recruiting

Address

INSELSPITAL, Universitätsspital Bern

Bern, , 3010

Kantonsspital St.Gallen, St. Gallen, Switzerland

Status

Not yet recruiting

Address

Kantonsspital St.Gallen

St. Gallen, , 9007

UniversitaetsSpital Zuerich, Zürich, Switzerland

Status

Not yet recruiting

Address

UniversitaetsSpital Zuerich

Zürich, ,

Birmingham, United Kingdom

Status

Not yet recruiting

Address

University Hospitals Birmingham NHS Trust,

Birmingham, , B15 2TH

Bristol Royal Infirmary, Bristol, United Kingdom

Status

Not yet recruiting

Address

Bristol Royal Infirmary

Bristol, , BS2 8BJ

Leeds Teaching Hospitals NHS Trust, Leeds,, United Kingdom

Status

Not yet recruiting

Address

Leeds Teaching Hospitals NHS Trust

Leeds,, , LS9 7TF

University College Hospital, London, United Kingdom

Status

Recruiting

Address

University College Hospital

London, , NW1 2BU

King's College Hospital, London, United Kingdom

Status

Recruiting

Address

King's College Hospital

London, , SE5 9RS

Manchester Royal Infirmary, Manchester, United Kingdom

Status

Not yet recruiting

Address

Manchester Royal Infirmary

Manchester, , M13 9WL

The Royal Marsden NHS Trust Sutton, Surrey, United Kingdom

Status

Recruiting

Address

The Royal Marsden NHS Trust Sutton

Surrey, , SM2 5PT