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NCT04458831Completed

A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

Primary Objective: To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice To describe safety of isatuximab in routine clinical practice (based on adverse event \[AE\] reporting) To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20) Secondary Objective: Not applicable

Status (registry)
Completed
Study type
Observational
Enrollment
583 (actual)
First submitted
25 Jun 2020
Start date
13 Aug 2020
Primary completion date
23 Feb 2026
Lead sponsor
Sanofi
NCT number
NCT04458831

What you commit to

  • Study type: Observational
  • Participants enrolled: 583
  • From 13 Aug 2020 to the primary completion date, 23 Feb 2026
  • 129 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.

Criteria the registry did not label

  • Age ≥18 years or country's legal age of majority if the legal age is \>18 years old at the time of enrollment
  • Patients with RRMM who have at least one prior line of therapy
  • Patients for whom the treating physician has made the decision to initiate isatuximab per routine practice and independently of the purpose of the study; for retrospectively enrolled patients, exposure to isatuximab treatment for a maximum of three months prior to study enrollment
  • Able to understand and complete the study-related questionnaires
  • Patient must have given signed informed consent prior to study start. For retrospectively enrolled patients who are deceased at the date of enrollment into the study, a waiver of consent will be required; patients who have started and stopped treatment or whose treatment is still ongoing at ICF are eligible
    • Most important exclusion criteria for potential participants:
  • Patients who are receiving isatuximab for an indication other than RRMM
  • Patients who have received any other investigational drug or prohibited therapy for this study within 28 days or five half-lives from randomization, whichever is longer
  • Patients having contraindication to the isatuximab summary of product characteristics (SMPC) or package insert (PI)
  • Patients having contraindications as noted in the drug-specific local isatuximab SMPC/PI of combination drugs
  • Any country-related specific regulation that would prevent the patient from entering the study
    • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Further eligibility criteria might apply.

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

Full criteria on ClinicalTrials.gov

Sites (129)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
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Abu DhabiUnited Arab EmiratesUnknown status
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Abu DhabiUnited Arab EmiratesUnknown 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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CórdobaArgentinaUnknown status
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PilarArgentinaUnknown status
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SteyrAustriaUnknown status
Institut Jules Bordet - Investigational Site Number : 0560001
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AnderlechtBelgiumUnknown status
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Sint-NiklaasBelgiumUnknown status
Kantonsspital Baden AG - Investigational Site Number : 5760003
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BadenSwitzerlandUnknown status
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BernSwitzerlandUnknown status
Stadtspital Triemli - Investigational Site Number : 5760002
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ZurichSwitzerlandUnknown status
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GuangzhouChinaUnknown status
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ShenzhenChinaUnknown status
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AschaffenburgGermanyUnknown status
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BambergGermanyUnknown status
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BayreuthGermanyUnknown status
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BerlinGermanyUnknown status
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BerlinGermanyUnknown status
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BerlinGermanyUnknown status
Praxis am Volkspark - Investigational Site Number : 2760009
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BerlinGermanyUnknown status
MV Zentrum für Onkologie und Hämatologie - Investigational Site Number : 2760034
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CologneGermanyUnknown status
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DonauwörthGermanyUnknown status
GEFOS Gesellschaft f. onkologische Studien -Investigational Site Number : 2760001
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DortmundGermanyUnknown status
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DresdenGermanyUnknown status
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DresdenGermanyUnknown status
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FrankfurtGermanyUnknown status
Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus - Investigational Site Number : 2760010
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Frankfurt am MainGermanyUnknown status
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HanoverGermanyUnknown status
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Herrsching am AmmerseeGermanyUnknown status
Klinikum Kulmbach mit Fachklinik Stadtsteinach - Investigational Site Number : 2760026
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KulmbachGermanyUnknown status
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LeipzigGermanyUnknown status
Philipps-Universitat Marburg, Klinic fur Innere Medizin -Investigational Site Number : 2760038
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MarburgGermanyUnknown status
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MünchenGermanyUnknown status
Klinikum Schwaebisch Gmuend - Investigational Site Number : 2760042
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MutlangenGermanyUnknown status
Dietrich-Bonhoeffer-Klinikum - Investigational Site Number : 2760044
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NeubrandenburgGermanyUnknown status
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OldenburgGermanyUnknown status
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OldenburgGermanyUnknown status
Klinikum Ernst von Bergmann gGmbH -Investigational Site Number : 2760039
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PotsdamGermanyUnknown status
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StolbergGermanyUnknown status
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WeilheimGermanyUnknown status
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WürzburgGermanyUnknown status
Hospital Universitario Virgen de la Nieves - Investigational Site Number : 7240010
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GranadaSpainUnknown status
Complejo Asistencial Universitario de Leon Altos de Nava s/n. -Investigational Site Number : 7240005
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LeónSpainUnknown status
Hospital Regional Universitario de Malaga Hospital Regional Universitario de Malaga - Investigational Site Number : 7240006
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MálagaSpainUnknown status
Hospital Universitari Son Espases - Investigational Site Number : 7240003
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Palma de MallorcaSpainUnknown status
Hospital Universitario de Navarra - Investigational Site Number : 7240009
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PamplonaSpainUnknown status
Complejo Hospitalario Universitario de Pontevedra - Investigational Site Number : 7240011
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PontevedraSpainUnknown status
omplejo Hospitalario Universitario de Canarias - Investigational Site Number : 7240007
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San Cristóbal de La LagunaSpainUnknown status
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ToledoSpainUnknown status
Centre Hospitalier Victor Dupouy - Investigational Site Number : 2500007
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ArgenteuilFranceUnknown status
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CahorsFranceUnknown status
Centre Hospitalier Metropole Savoie - Investigational Site Number : 2500006
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ChambéryFranceUnknown status
Clinique Louis Pasteur, Maison Médicale - Investigational Site Number : 2500012
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Essey-lès-NancyFranceUnknown status
Centre Hospitalier Le Mans - Investigational Site Number : 2500015
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Le MansFranceUnknown status
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LilleFranceUnknown status
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MontpellierFranceUnknown status
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PessacFranceUnknown status
CHU Poitiers - Hôpital la Milétrie - Investigational Site Number : 2500008
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PoitiersFranceUnknown status
CHU Reims - Hôpital Robert Debré - Investigational Site Number : 2500010
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ReimsFranceUnknown status
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RouenFranceUnknown status
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Saint-Priest-en-JarezFranceUnknown status
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Saint-QuentinFranceUnknown status
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TarbesFranceUnknown status
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VannesFranceUnknown status
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HuddersfieldUnited KingdomUnknown status
Freeman Hospital - Investigational Site Number : 8260003
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Newcastle upon TyneUnited KingdomUnknown status
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NottinghamUnited KingdomUnknown status
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SuttonUnited KingdomUnknown status
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PiraeusGreeceUnknown status
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Hong KongHong KongUnknown status
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BariItalyUnknown status
Istituto di Ematologia e Oncologia Medica - Investigational Site Number : 3800005
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BolognaItalyUnknown status
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800007
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BresciaItalyUnknown status
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MilanItalyUnknown status
Azienda Ospedaliera Universitaria "Federico II"-Investigational Site Number : 3800001
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NaplesItalyUnknown status
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NovaraItalyUnknown status
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PaviaItalyUnknown status
Azienda Ospedaliera Universitaria Policlinico Umberto I - Investigational Site Number : 3800002
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RomeItalyUnknown status
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia - Investigational Site Number : 3800009
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RomeItalyUnknown status
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TrentoItalyUnknown status
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TrevisoItalyUnknown status
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FukuokaJapanUnknown status
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Minato-kuJapanUnknown status
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MinatokuJapanUnknown status
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OkayamaJapanUnknown status
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OsakaJapanUnknown status
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Osakasayama-shiJapanUnknown status
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SapporoJapanUnknown status
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Shibukawa-shiJapanUnknown status
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Sunto-gunJapanUnknown status
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Suwa-shiJapanUnknown status
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YamagataJapanUnknown status
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Kuwait CityKuwaitUnknown status
Albert Schweitzer Ziekenhuis - Investigational Site Number : 5820001
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DordrechtNetherlandsUnknown status
Puerto Rico Medical Research Center, LLC Site Number : 8400001
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Hato ReyPuerto RicoUnknown status
Auxilio Mutuo Cancer Center Site Number : 8400029
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San JuanPuerto RicoUnknown status
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VolgogradRussiaUnknown status
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JeddahSaudi ArabiaUnknown status
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JeddahSaudi ArabiaUnknown status
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KhobarSaudi ArabiaUnknown status
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RiyadhSaudi ArabiaUnknown status
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Kaohsiung CityTaiwanUnknown status
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TaipeiTaiwanUnknown status
Hematology & Oncology Associates Site Number : 8400015
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CantonUnited StatesUnknown status
Charleston Hematology Oncology Associates, PA Site Number : 8400020
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CharlestonUnited StatesUnknown status
Michigan Center of Medical Research Site Number : 8400010
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Farmington HillsUnited StatesUnknown status
Holy Cross Hospital Site Number : 8400030
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Fort LauderdaleUnited StatesUnknown status
Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017
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FreeholdUnited StatesUnknown status
St. Joseph Heritage Healthcare Site Number : 8400008
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FullertonUnited StatesUnknown status
Central Care Cancer Center Site Number : 8400006
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Garden CityUnited StatesUnknown status
Central Care Cancer Center Site Number : 8400019
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Garden CityUnited StatesUnknown status
Prisma Health - Eastside Office Site Number : 8400011
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GreenvilleUnited StatesUnknown status
MD Anderson Cancer Center Site Number : 8400013
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HoustonUnited StatesUnknown status
Regional Cancer Care Associates Site Number : 8400024
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Howell TownshipUnited StatesUnknown status
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JacksonvilleUnited StatesUnknown status
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Kansas CityUnited StatesUnknown status
Watson Clinic Cancer and Research Center Site Number : 8400023
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LakelandUnited StatesUnknown status
Central Maine Medical Center Site Number : 8400031
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LewistonUnited StatesUnknown status
University of Arkansas Medical Sciences Site Number : 8400021
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Little RockUnited StatesUnknown status
Regional Cancer Care Associates - Little Silver Division Site Number : 8400018
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Little SilverUnited StatesUnknown status
Tri County Hematology & Oncology Associates, Inc Site Number : 8400012
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MassillonUnited StatesUnknown status
Millennium Oncology Site Number : 8400025
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Pembroke PinesUnited StatesUnknown status
University of California San Francisco (PARENT) Site Number : 8400009
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San FranciscoUnited StatesUnknown status
Comprehensive Hematology Oncology Site Number : 8400026
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St. PetersburgUnited StatesUnknown status
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The WoodlandsUnited StatesUnknown status
Prairie Lakes Health Care System, Inc Site Number : 8400002
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WatertownUnited StatesUnknown status
Novant Health Forsyth Medical Center Site Number : 8400028
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Winston-SalemUnited StatesUnknown status

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