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NCT03277105CompletedPhase 3

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma

Source: ClinicalTrials.gov · Last updated 29 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
522 (actual)
First submitted
7 Sept 2017
Start date
27 Oct 2017
Primary completion date
27 Jun 2019
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT03277105
EudraCT number
2017-000206-38

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 522
  • From 27 Oct 2017 to the primary completion date, 27 Jun 2019
  • 146 sites in 18 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

  • Received daratumumab or other anti-CD38 therapies previously
  • Received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of randomization. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) before treatment
  • Received autologous stem cell transplant within 12 weeks before the date of randomization, or the participant has previously received allogeneic stem cell transplant (regardless of timing)
  • Plans to undergo a stem cell transplant prior to progression of disease on this study (these participants should not be enrolled to reduce disease burden prior to transplant)

Other illness

  • History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years

Who the study is looking for

  • Evidence of a response (Partial response \[PR\] or better based on investigator's determination of response by international myeloma working group \[IMWG\] criteria) to at least 1 prior treatment regimen
  • Received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to \[\>=\] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (\>=2 cycles or 2 months of treatment) in any order during the course of treatment (except for participants who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months). A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram/day \[mg/day\] for 4 days) would not be considered prior lines of therapy
  • Documented multiple myeloma as defined by the criteria below:
    • Multiple myeloma diagnosis according to the IMWG diagnostic criteria
    • Measurable disease at Screening as defined by any of the following:
    • Serum M-protein level \>=1.0 gram per deciliter (g/dL) or urine M-protein level \>=200 mg/24 hours; or
    • Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Meet the clinical laboratory criteria as specified in the protocol
  • Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization

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

Full criteria on ClinicalTrials.gov

Sites (146)

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

SiteCityCountrySite status
Royal Prince Alfred Hospital
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CamperdownAustraliaUnknown status
St Vincents Hospital Melbourne
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FitzroyAustraliaUnknown status
Alfred Health
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MelbourneAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
Sir Charles Gairdner Hospital
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NedlandsAustraliaUnknown status
Calvary Mater Newcastle Hospital
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WaratahAustraliaUnknown status
The Queen Elizabeth Hospital
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Woodville SouthAustraliaUnknown status
Princess Alexandra Hospital
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WoolloongabbaAustraliaUnknown status
Fundacao Pio XII
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BarretosBrazilUnknown status
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
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FlorianópolisBrazilUnknown status
Fundacao Doutor Amaral Carvalho
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JaúBrazilUnknown status
Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia
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JoinvilleBrazilUnknown status
Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo
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Passo FundoBrazilUnknown status
Hospital das Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Instituto de Educacao Pesquisa e Gestao em Saude
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Rio de JaneiroBrazilUnknown status
CEHON
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SalvadorBrazilUnknown status
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base
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São José do Rio PretoBrazilUnknown status
Hospital das Clinicas da Faculdade de Medicina da USP
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São PauloBrazilUnknown status
Clinica Sao Germano
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São PauloBrazilUnknown status
Tom Baker Cancer Centre
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CalgaryCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
QEII Health Sciences Centre
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HalifaxCanadaUnknown status
Victoria Hospital
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LondonCanadaUnknown status
CHU de Quebec - L'Hôtel-Dieu de Québec
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QuébecCanadaUnknown status
Princess Margaret Hospital
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TorontoCanadaUnknown status
The Gordon & Leslie Diamond Health Care Center
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VancouverCanadaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaUnknown status
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaUnknown status
Fakultni nemocnice Olomouc
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OlomoucCzechiaUnknown status
Fakultni nemocnice Ostrava
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OstravaCzechiaUnknown status
Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni
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PilsenCzechiaUnknown status
Fakultni nemocnice Kralovske Vinohrady
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PragueCzechiaUnknown status
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
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PragueCzechiaUnknown status
Hosp. Univ. Germans Trias I Pujol
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BadalonaSpainUnknown status
Hosp Clinic de Barcelona
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BarcelonaSpainUnknown status
Hosp. Univ. Dr. Josep Trueta
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GironaSpainUnknown status
Hosp. Univ. Virgen de Las Nieves
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GranadaSpainUnknown status
Hosp. de Leon
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LeónSpainUnknown status
Hosp. Gral. Univ. Gregorio Maranon
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MadridSpainUnknown status
Hosp. Univ. 12 de Octubre
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MadridSpainUnknown status
Hosp. Univ. Infanta Leonor
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MadridSpainUnknown status
Clinica Univ. de Navarra
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PamplonaSpainUnknown status
Hosp. Quiron Madrid Pozuelo
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Pozuelo de AlarcónSpainUnknown status
Hosp Clinico Univ de Salamanca
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SalamancaSpainUnknown status
Hosp. Univ. de Canarias
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San Cristóbal de La LagunaSpainUnknown status
Hosp. Univ. Dr. Peset
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ValenciaSpainUnknown status
CHU Caen - Côte de Nacre
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CaenFranceUnknown status
Hopital Claude Huriez
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LilleFranceUnknown status
CHU de Nantes - Hôtel Dieu
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NantesFranceUnknown status
CHU de Boreaux
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PessacFranceUnknown status
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceUnknown status
CHU Poitiers - Hôpital la Milétrie
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PoitiersFranceUnknown status
CHU Nancy-Brabois
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Vandœuvre-lès-NancyFranceUnknown status
Blackpool Victoria Hospital
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BlackpoolUnited KingdomUnknown status
Royal Bournemouth Hospital
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BournemouthUnited KingdomUnknown status
Leicester Royal Infirmary - Haematology
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LeicesterUnited KingdomUnknown status
St. Bartholomew's Hospital
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LondonUnited KingdomUnknown status
Guys & St Thomas Hospital
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LondonUnited KingdomUnknown status
Christie Hospital NHS Trust
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ManchesterUnited KingdomUnknown status
Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
Royal Marsden Hospital
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SurreyUnited KingdomUnknown status
New Cross Hospital
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WolverhamptonUnited KingdomUnknown status
Alexandra General Hospital of Athens
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Athens AtticaGreeceUnknown status
Hillel Yaffe Medical Center - Oncology
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HaderaIsraelUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Rambam Med.Center - Hematology Institute
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HaifaIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Rabin Medical Center-Beilinson Campus
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Petah TikvaIsraelUnknown 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
Policlinico Sant'Orsola-Malpighi
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BolognaItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyUnknown status
Ospedale Villa Sofia-Cervello
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PalermoItalyUnknown status
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyUnknown status
Azienda USL di Piacenza
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PiacenzaItalyUnknown status
Policlinico Universitario Agostino Gemelli
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RomaItalyUnknown status
Università di Roma La Sapienza
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RomaItalyUnknown status
A.O.U. Città della Salute e della Scienza
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TorinoItalyUnknown status
Fukuoka University Hospital
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FukuokaJapanUnknown status
Chugoku Central Hospital
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FukuyamaJapanUnknown status
Ogaki Municipal Hospital
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GifuJapanUnknown status
Gunma University Hospital
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GunmaJapanUnknown status
Kobe City Medical Center General Hospital
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KobeJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Matsuyama Red Cross Hospital
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MatsuyamaJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
Japanese Red Cross Nagoya Daini Hospital
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NagoyaJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Iwate Medical University Hospital
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NumakunaiJapanUnknown status
National Hospital Organization Okayama Medical Center
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OkayamaJapanUnknown status
Osaka University Hospital
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OsakaJapanUnknown status
National Hospital Organization Sendai Medical Center
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SendaiJapanUnknown status
National Hospital Organization Shibukawa Medical Center
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ShibukawaJapanUnknown status
Japanese Red Cross Medical Center
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Shibuya CityJapanUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
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SeoulSouth KoreaUnknown status
Severance hospital
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SeoulSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandUnknown status
Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
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BydgoszczPolandUnknown status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
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ChorzówPolandUnknown status
Szpitale Pomorskie Sp z o o
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GdyniaPolandUnknown status
Szpital Uniwersytecki w Krakowie
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KrakowPolandUnknown status
Wojewodzki Szpital Specjalistyczny w Legnicy
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LegnicaPolandUnknown status
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
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LublinPolandUnknown status
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
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PoznanPolandUnknown status
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandUnknown status
Emergency Hospital of Dzerzhinsk
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DzerzhinskRussiaUnknown status
City Clinical Hospital # 40
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MoscowRussiaUnknown status
S.P. Botkin Moscow City Clinical Hospital
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MoscowRussiaUnknown status
Nizhniy Novgorod Region Clinical Hospital
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Nizny NovgorodRussiaUnknown status
Penza Regional Oncology Dispensary
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PenzaRussiaUnknown status
Ryazan Regional Clinical Hospital
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RyazanRussiaUnknown status
Saint Petersburg City Hospital #15
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Saint PetersburgRussiaUnknown status
Clinical Research Institute of Hematology and Transfusiology
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Saint PetersburgRussiaUnknown status
Samara Region Clinical Hospital
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SamaraRussiaUnknown status
Oncology Dispensary of Komi Republic
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SyktyvkarRussiaUnknown status
Ekaterinburg City Clinical Hospital # 7
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YekaterinburgRussiaUnknown status
Falu Lasarett
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FalunSwedenUnknown status
Helsingborgs lasarett
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HelsingborgSwedenUnknown status
Karolinska University Hospital, Huddinge
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HuddingeSwedenUnknown status
Skanes universitetssjukhus
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LundSwedenUnknown status
Norrlands University Hospital
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UmeåSwedenUnknown status
Akademiska sjukhuset
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UppsalaSwedenUnknown status
Chang-Hua Christian Hospital
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ChanghuaTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'
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CherkasyUkraineUnknown status
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
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DniproUkraineUnknown status
Ivano-Frankivsk Regional Clinical Hospital
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Ivano-FrankivskUkraineUnknown status
SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine
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KharkivUkraineUnknown status
State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'
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KievUkraineUnknown status
Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department
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KievUkraineUnknown status
National Cancer Institute, Dept. of chemotherapy of hemoblastosis
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KievUkraineUnknown status
Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine
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LvivUkraineUnknown status
Mykolaiv Regional Clinical Hospital
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MykolaivUkraineUnknown status
Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital
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PoltavaUkraineUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status

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