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NCT05405166Active, not recruitingPhase 3

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

A Randomized, Phase 3, Open Label Study Evaluating Subcutaneous Versus Intravenous Administration of Isatuximab in Combination With Pomalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

This will be randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who will receive at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants were randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants are allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
531 (actual)
First submitted
31 May 2022
Start date
23 Jun 2022
Primary completion date
6 Nov 2024
Lead sponsor
Sanofi
NCT number
NCT05405166
EudraCT number
2023-508869-32

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 531
  • From 23 Jun 2022 to the primary completion date, 6 Nov 2024
  • 128 sites in 21 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

  • Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received
  • Prior therapy with pomalidomide
  • Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
  • Concomitant plasma cell leukemia

Other illness

  • Significant cardiac dysfunction
  • Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment
  • Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.

Other

  • Primary refractory multiple myeloma participants
  • Participants with inadequate biological tests.
  • Active primary amyloid light -chain amyloidosis
  • Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control
    • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Who the study is looking for

  • Participants with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination.
  • Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (\<0.26 or \>1.65)).

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
Investigational Site Number : 0320008
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320005
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320003
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320004
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320001
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320002
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320007
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Buenos AiresArgentinaUnknown status
Investigational Site Number : 0320010
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CórdobaArgentinaUnknown status
Investigational Site Number : 0320006
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La PlataArgentinaUnknown status
Investigational Site Number : 0320009
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MendozaArgentinaUnknown status
Investigational Site Number : 0360008
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AdelaideAustraliaUnknown status
Investigational Site Number : 0360007
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LiverpoolAustraliaUnknown status
Investigational Site Number : 0360006
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MelbourneAustraliaUnknown status
Investigational Site Number : 0360009
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MelbourneAustraliaUnknown status
Investigational Site Number : 0360001
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RichmondAustraliaUnknown status
Investigational Site Number : 0360004
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WaratahAustraliaUnknown status
Investigational Site Number : 0360003
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WollongongAustraliaUnknown status
Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
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FortalezaBrazilUnknown status
CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
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NiteróiBrazilUnknown status
Hospital Mae de Deus- Site Number : 0760003
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Porto AlegreBrazilUnknown status
MultiHemo - Recife - Rua Padre Carapuceiro- Site Number : 0760007
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RecifeBrazilUnknown status
Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
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Rio de JaneiroBrazilUnknown status
Clinica São Germano- Site Number : 0760001
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São PauloBrazilUnknown status
Investigational Site Number : 1240004
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Greenfield ParkCanadaUnknown status
Investigational Site Number : 1240003
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MontrealCanadaUnknown status
Investigational Site Number : 1240001
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TorontoCanadaUnknown status
Investigational Site Number : 1520003
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SantiagoChileUnknown status
Investigational Site Number : 1520004
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SantiagoChileUnknown status
Investigational Site Number : 1520002
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SantiagoChileUnknown status
Investigational Site Number : 1520006
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SantiagoChileUnknown status
Investigational Site Number : 1520001
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TemucoChileUnknown status
Investigational Site Number : 1520005
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Viña del MarChileUnknown status
Investigational Site Number : 1560001
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BeijingChinaUnknown status
Investigational Site Number : 1560022
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BeijingChinaUnknown status
Investigational Site Number : 1560010
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ChangshaChinaUnknown status
Investigational Site Number : 1560006
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GuangzhouChinaUnknown status
Investigational Site Number : 1560002
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HangzhouChinaUnknown status
Investigational Site Number : 1560020
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NanchangChinaUnknown status
Investigational Site Number : 1560019
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NanningChinaUnknown status
Investigational Site Number : 1560011
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QingdaoChinaUnknown status
Investigational Site Number : 1560013
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ShenyangChinaUnknown status
Investigational Site Number : 1560018
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TianjinChinaUnknown status
Investigational Site Number : 1560007
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TianjinChinaUnknown status
Investigational Site Number : 1560009
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TianjinChinaUnknown status
Investigational Site Number : 1560008
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WuhanChinaUnknown status
Investigational Site Number : 1560003
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WuhanChinaUnknown status
Investigational Site Number : 1560004
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ZhengzhouChinaUnknown status
Investigational Site Number : 2030005
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BrnoCzechiaUnknown status
Investigational Site Number : 2030003
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OlomoucCzechiaUnknown status
Investigational Site Number : 2030006
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OstravaCzechiaUnknown status
Investigational Site Number : 2030004
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PragueCzechiaUnknown status
Investigational Site Number : 2760005
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DresdenGermanyUnknown status
Investigational Site Number : 2760003
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HeidelbergGermanyUnknown status
Investigational Site Number : 2760006
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LübeckGermanyUnknown status
Investigational Site Number : 2760007
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NurembergGermanyUnknown status
Investigational Site Number : 7240004
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BadalonaSpainUnknown status
Investigational Site Number : 7240005
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MadridSpainUnknown status
Investigational Site Number : 7240006
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MurciaSpainUnknown status
Investigational Site Number : 7240001
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PamplonaSpainUnknown status
Investigational Site Number : 7240002
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SalamancaSpainUnknown status
Investigational Site Number : 7240003
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SantanderSpainUnknown status
Investigational Site Number : 2500002
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NantesFranceUnknown status
Investigational Site Number : 2500005
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ParisFranceUnknown status
Investigational Site Number : 2500001
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PoitiersFranceUnknown status
Investigational Site Number : 2500009
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Saint-Priest-en-JarezFranceUnknown status
Investigational Site Number : 2500003
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ToulouseFranceUnknown status
Investigational Site Number : 2500007
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ToursFranceUnknown status
Investigational Site Number : 8260004
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BirminghamUnited KingdomUnknown status
Investigational Site Number : 8260003
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DerbyUnited KingdomUnknown status
Investigational Site Number : 8260002
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LeicesterUnited KingdomUnknown status
Investigational Site Number : 8260005
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LondonUnited KingdomUnknown status
Investigational Site Number : 8260001
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NorwichUnited KingdomUnknown status
Investigational Site Number : 3000002
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AthensGreeceUnknown status
Investigational Site Number : 3000001
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AthensGreeceUnknown status
Investigational Site Number : 3000003
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PátraiGreeceUnknown status
Investigational Site Number : 3000004
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ThessalonikiGreeceUnknown status
Investigational Site Number : 3480004
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BudapestHungaryUnknown status
Investigational Site Number : 3480002
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BudapestHungaryUnknown status
Investigational Site Number : 3480003
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KaposvárHungaryUnknown status
Investigational Site Number : 3480008
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PécsHungaryUnknown status
Investigational Site Number : 3480005
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SzékesfehérvárHungaryUnknown status
Investigational Site Number : 3480006
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SzombathelyHungaryUnknown status
Investigational Site Number : 3800002
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BolognaItalyUnknown status
Investigational Site Number : 3800005
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BresciaItalyUnknown status
Investigational Site Number : 3800001
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MeldolaItalyUnknown status
Investigational Site Number : 3800003
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PaviaItalyUnknown status
Investigational Site Number : 3800006
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RomeItalyUnknown status
Investigational Site Number : 3800004
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ToretteItalyUnknown status
Investigational Site Number : 3920005
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HigashiibarakiJapanUnknown status
Investigational Site Number : 3920012
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KamakuraJapanUnknown status
Investigational Site Number : 3920007
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KamogawaJapanUnknown status
Investigational Site Number : 3920003
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KyotoJapanUnknown status
Investigational Site Number : 3920001
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NagoyaJapanUnknown status
Investigational Site Number : 3920002
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OkayamaJapanUnknown status
Investigational Site Number : 3920011
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OsakaJapanUnknown status
Investigational Site Number : 3920004
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TokyoJapanUnknown status
Investigational Site Number : 3920010
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YahabaJapanUnknown status
Investigational Site Number : 3920009
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YamagataJapanUnknown status
Investigational Site Number : 5780002
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ÅlesundNorwayUnknown status
Investigational Site Number : 5780001
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OsloNorwayUnknown status
Investigational Site Number : 6160005
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KrakowPolandUnknown status
Investigational Site Number : 6160001
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LublinPolandUnknown status
Investigational Site Number : 6160004
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WroclawPolandUnknown status
Investigational Site Number : 7520001
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BoråsSwedenUnknown status
Investigational Site Number : 7520003
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HuddingeSwedenUnknown status
Investigational Site Number : 1580001
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Kaohsiung CityTaiwanUnknown status
Investigational Site Number : 1580005
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TainanTaiwanUnknown status
Investigational Site Number : 1580002
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TaipeiTaiwanUnknown status
New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
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AlbanyUnited StatesUnknown status
Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
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AuroraUnited StatesUnknown status
Gabrail Cancer Center- Site Number : 8400027
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CantonUnited StatesUnknown status
Novant Health Neurology & Sleep- Site Number : 8400014
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CharlotteUnited StatesUnknown status
University of Texas - Southwestern Medical Center- Site Number : 8400024
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DallasUnited StatesUnknown status
Oncology Hematology Care - Fairfield- Site Number : 8400016
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FairfieldUnited StatesUnknown status
Hattiesburg Clinic- Site Number : 8400006
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HattiesburgUnited StatesUnknown status
Mayo Clinic in Florida- Site Number : 8400008
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JacksonvilleUnited StatesUnknown status
Atlantic Health System- Site Number : 8400005
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MorristownUnited StatesUnknown status
Boca Raton Clinical Research Associates- Site Number : 8400030
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PlantationUnited StatesUnknown status
Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
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Salt Lake CityUnited StatesUnknown status
Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020
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San AntonioUnited StatesUnknown status
Spartanburg Regional Medical Center- Site Number : 8400002
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SpartanburgUnited StatesUnknown status
Investigational Site Number : 7920007
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AnkaraTurkey (Türkiye)Unknown status
Investigational Site Number : 7920009
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AnkaraTurkey (Türkiye)Unknown status
Investigational Site Number : 7920008
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IstanbulTurkey (Türkiye)Unknown status
Investigational Site Number : 7920003
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IstanbulTurkey (Türkiye)Unknown status
Investigational Site Number : 7920001
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IstanbulTurkey (Türkiye)Unknown status
Investigational Site Number : 7920005
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IstanbulTurkey (Türkiye)Unknown status
Investigational Site Number : 7920004
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IzmirTurkey (Türkiye)Unknown status

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