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NCT02195479CompletedPhase 3

A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma

A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy

Source: ClinicalTrials.gov · Last updated 22 Aug 2025

Brief summary (registry, in English)

The purpose of this study is to determine if the addition of daratumumab to velcade (bortezomib) melphalan-prednisone (VMP) will prolong progression-free survival (PFS) compared with VMP alone in participants with previously untreated multiple myeloma who are ineligible for high dose chemotherapy and autologous stem cell transplant (ASCT).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
706 (actual)
First submitted
18 Jul 2014
Start date
9 Dec 2014
Primary completion date
21 Nov 2017
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT02195479
EudraCT number
2014-002272-88

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 706
  • From 9 Dec 2014 to the primary completion date, 21 Nov 2017
  • 160 sites in 24 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

  • Participant has prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for 4 days) of corticosteroids before treatment
  • Participant has had radiation therapy within 14 days of randomization
  • Participant has any concurrent medical or psychiatric condition or disease (example active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) 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

Other illness

  • Participant has a diagnosis of Waldenstrom's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
  • Participant has 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 4
  • Participant has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy 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)
  • Participant has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second \[FEV1\] \<50% of predicted normal), known moderate or severe persistent asthma within the last 2 years or currently has uncontrolled asthma of any classification (controlled intermittent asthma or controlled mild persistent asthma is allowed)
  • Participant is known to be seropositive for human immunodeficiency virus (HIV), known to have hepatitis B surface antigen positivity, or history of to have a history of hepatitis C

Other

  • Participant has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
  • Participant has had plasmapheresis within 28 days of randomization
  • Participants with known or suspected COPD must have a FEV1 test during screening

Who the study is looking for

  • Participant must have documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic criteria, monoclonal plasma cells in the bone marrow greater than or equal to 10 percent (%) or presence of a biopsy proven plasmacytoma, and measurable secretory disease, as assessed by the central laboratory, and defined in protocol
  • Participants who are newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age \>=65 years, or in participants \<65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  • Meet the clinical laboratory criteria as specified in the protocol
  • A woman of childbearing potential must have a negative serum pregnancy test at screening within 14 days prior to randomization
  • Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device, hormonal \[birth control pills, injections, hormonal patches, vaginal rings or implants\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy

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

Full criteria on ClinicalTrials.gov

Sites (160)

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

SiteCityCountrySite status
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Buenos AiresArgentinaUnknown status
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Ciudad Autonoma Buenos AiresArgentinaUnknown status
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CórdobaArgentinaUnknown status
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Santa FeArgentinaUnknown status
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AdelaideAustraliaUnknown status
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BendigoAustraliaUnknown status
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CamperdownAustraliaUnknown status
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GeelongAustraliaUnknown status
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GosfordAustraliaUnknown status
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GreenslopesAustraliaUnknown status
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HobartAustraliaUnknown status
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North AdelaideAustraliaUnknown status
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ParkvilleAustraliaUnknown status
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AntwerpBelgiumUnknown status
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BrusselsBelgiumUnknown status
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CharleroiBelgiumUnknown status
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GhentBelgiumUnknown status
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KortrijkBelgiumUnknown status
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RoeselareBelgiumUnknown status
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TurnhoutBelgiumUnknown status
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YvoirBelgiumUnknown status
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PlevenBulgariaUnknown status
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PlovdivBulgariaUnknown status
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SofiaBulgariaUnknown status
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VarnaBulgariaUnknown status
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VratsaBulgariaUnknown status
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BarretosBrazilUnknown status
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Cuiaba - MountBrazilUnknown status
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FortalezaBrazilUnknown status
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GoiâniaBrazilUnknown status
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NatalBrazilUnknown status
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Porto AlegreBrazilUnknown status
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Ribeirão PretoBrazilUnknown status
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Rio de JaneiroBrazilUnknown status
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São PauloBrazilUnknown status
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BrnoCzechiaUnknown status
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Hradec KrálovéCzechiaUnknown status
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OlomoucCzechiaUnknown status
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Ostrava-PorubaCzechiaUnknown status
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PragueCzechiaUnknown status
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BerlinGermanyUnknown status
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DortmundGermanyUnknown status
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KarlsruheGermanyUnknown status
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PotsdamGermanyUnknown status
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SaarbrückenGermanyUnknown status
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StuttgartGermanyUnknown status
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WürzburgGermanyUnknown status
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AndalucíaSpainUnknown status
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BadalonaSpainUnknown status
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BarcelonaSpainUnknown status
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CórdobaSpainUnknown status
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GironaSpainUnknown status
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MadridSpainUnknown status
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MarañónSpainUnknown status
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MurciaSpainUnknown status
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OurenseSpainUnknown status
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PamplonaSpainUnknown status
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SalamancaSpainUnknown status
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San Cristóbal de La LagunaSpainUnknown status
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SevilleSpainUnknown status
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ToledoSpainUnknown status
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ValenciaSpainUnknown status
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ZaragozaSpainUnknown status
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BirminghamUnited KingdomUnknown status
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CambridgeUnited KingdomUnknown status
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ColchesterUnited KingdomUnknown status
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HarlowUnited KingdomUnknown status
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LeicesterUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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ManchesterUnited KingdomUnknown status
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WoolwichUnited KingdomUnknown status
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TbilisiGeorgiaUnknown status
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AthensGreeceUnknown status
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Athens AtticaGreeceUnknown status
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PátraiGreeceUnknown status
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ThessalonikiGreeceUnknown status
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ZadarCroatiaUnknown status
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ZagrebCroatiaUnknown status
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BudapestHungaryUnknown status
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DebrecenHungaryUnknown status
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KaposvárHungaryUnknown status
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PécsHungaryUnknown status
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ChibaJapanUnknown status
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HitachiJapanUnknown status
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KanazawaJapanUnknown status
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KawasakiJapanUnknown status
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KobeJapanUnknown status
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KurumeJapanUnknown status
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MatsuyamaJapanUnknown status
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NagoyaJapanUnknown status
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NaritaJapanUnknown status
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OhgakiJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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SendaiJapanUnknown status
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ShibukawaJapanUnknown status
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Shibuya CityJapanUnknown status
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TachikawaJapanUnknown status
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ToyohashiJapanUnknown status
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BusanSouth KoreaUnknown status
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Gyeonggi-doSouth KoreaUnknown status
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HwasunSouth KoreaUnknown status
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IncheonSouth KoreaUnknown status
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SeongnamSouth KoreaUnknown status
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SeoulSouth KoreaUnknown status
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SkopjeNorth MacedoniaUnknown status
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BialystokPolandUnknown status
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BydgoszczPolandUnknown status
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ChorzówPolandUnknown status
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GdanskPolandUnknown status
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LegnicaPolandUnknown status
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LublinPolandUnknown status
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OpolePolandUnknown status
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SłupskPolandUnknown status
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WarsawPolandUnknown status
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Warszawa UlPolandUnknown status
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WroclawPolandUnknown status
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LisbonPortugalUnknown status
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PortoPortugalUnknown status
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BrasovRomaniaUnknown status
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BucharestRomaniaUnknown status
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IașiRomaniaUnknown status
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BelgradeSerbiaUnknown status
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KamenitzSerbiaUnknown status
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NišSerbiaUnknown status
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Novi SadSerbiaUnknown status
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ZemunSerbiaUnknown status
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ArkhangelskRussiaUnknown status
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DzerzhinskRussiaUnknown status
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Nizhny NovgorodRussiaUnknown status
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RyazanRussiaUnknown status
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Saint PetersburgRussiaUnknown status
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SaratovRussiaUnknown status
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SochiRussiaUnknown status
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VolgogradRussiaUnknown status
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YekaterinburgRussiaUnknown status
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CherkassyUkraineUnknown status
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DniproUkraineUnknown status
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Ivano-FrankivskUkraineUnknown status
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KharkivUkraineUnknown status
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KhmelnitskiyUkraineUnknown status
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LvivUkraineUnknown status
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ZaporizhzhyaUkraineUnknown status
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California CityUnited StatesUnknown status
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ChicagoUnited StatesUnknown status
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ClevelandUnited StatesUnknown status
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CoronaUnited StatesUnknown status
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Fountain ValleyUnited StatesUnknown status
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FredericksburgUnited StatesUnknown status
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HialeahUnited StatesUnknown status
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Los AngelesUnited StatesUnknown status
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Orange ParkUnited StatesUnknown status
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SpringfieldUnited StatesUnknown status
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AltındağTurkey (Türkiye)Unknown status
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AnkaraTurkey (Türkiye)Unknown status
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AydinTurkey (Türkiye)Unknown status
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IzmirTurkey (Türkiye)Unknown status
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KayseriTurkey (Türkiye)Unknown status
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SamsunTurkey (Türkiye)Unknown status
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TekirdağTurkey (Türkiye)Unknown status

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