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NCT06158841Active, not recruitingPhase 3

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Source: ClinicalTrials.gov · Last updated 27 Aug 2026

Brief summary (registry, in English)

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
421 (actual)
First submitted
28 Nov 2023
Start date
19 May 2024
Primary completion date
Dec 2027
Lead sponsor
AbbVie
NCT number
NCT06158841
EU CT number
2023-506668-15-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 421
  • From 19 May 2024 to the primary completion date, Dec 2027
  • 156 sites in 25 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

  • Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
  • Has received B-cell maturation antigen (BCMA)-targeted therapy.

Other illness

  • Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.

Other

  • Central nervous system involvement of MM.

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
  • Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
  • Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
    • Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
    • Urine M-protein \>= 200 mg/24 hours.
    • In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
  • Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
    • \-- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.
  • Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.

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

Full criteria on ClinicalTrials.gov

Sites (156)

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

SiteCityCountrySite status
Medical University of Graz
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GrazAustriaActive, not recruiting
Universitaetsklinikum Krems
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Krems An Der DonauAustriaActive, not recruiting
Ordensklinikum Linz GmbH
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LinzAustriaActive, not recruiting
Stadt Wien Wiener Gesundheitsverbund
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ViennaAustriaActive, not recruiting
Monash Health - Monash Medical Centre - Clayton /ID# 262158
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ClaytonAustraliaUnknown status
St Vincent's Hospital Melbourne /ID# 261808
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Fitzroy MelbourneAustraliaUnknown status
St George Hospital - Kogarah /ID# 261806
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KogarahAustraliaUnknown status
Liverpool Hospital /ID# 262159
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LiverpoolAustraliaUnknown status
Box Hill Hospital /ID# 262784
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MelbourneAustraliaUnknown status
Calvary Mater Newcastle /ID# 261804
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WaratahAustraliaUnknown status
Princess Alexandra Hospital - Woolloongabba /ID# 261810
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WoolloongabbaAustraliaUnknown status
Algemeen Ziekenhuis klina
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BrasschaatBelgiumActive, not recruiting
University Health Network_Princess Margaret Cancer Centre /ID# 261566
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TorontoCanadaUnknown status
Peking Union Medical College Hospital East - Dongdan Campus /ID# 245545
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BeijingChinaUnknown status
Beijing Chaoyang Hospital,Capital Medical University /ID# 245533
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BeijingChinaUnknown status
Fujian Medical University Union Hospital /ID# 245558
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FuzhouChinaUnknown status
Sun Yat-Sen University Cancer Center /ID# 245542
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GuangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882
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HangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883
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HangzhouChinaUnknown status
The First Affiliated Hospital of Nanchang University /ID# 245537
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NanchangChinaUnknown status
Zhongda Hospital Southeast University /ID# 245563
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NanjingChinaUnknown status
Shanghai Tongji Hospital /ID# 245539
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ShanghaiChinaUnknown status
First Affiliated Hospital of China Medical University /ID# 245547
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ShenyangChinaUnknown status
The First Affiliated Hospital of Soochow University /ID# 245544
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SuzhouChinaUnknown status
Tianjin Medical University General Hospital /ID# 260851
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TianjinChinaUnknown status
Institute of Hematology and Blood Diseases Hospital /ID# 265702
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University /ID# 245550
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WenzhouChinaUnknown status
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549
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WuhanChinaUnknown status
Second Affiliated Hospital of Xian Jiaotong University /ID# 261255
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Xi'anChinaUnknown status
Henan Cancer Hospital /ID# 245536
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ZhengzhouChinaUnknown status
People's Hospital of Henan Province /ID# 260918
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ZhengzhouChinaUnknown status
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaActive, not recruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
Odense University Hospital
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Odense CDenmarkActive, not recruiting
Lillebaelt Hospital
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VejleDenmarkActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Area De Salud De Leon Y El Bierzo
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LeonSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Complejo Hospitalario Universitario de Ourense
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OurenseSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Centre Hospitalier d'Avignon
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AvignonFranceActive, not recruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceActive, not recruiting
Addenbrookes Hospital /ID# 261104
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CambridgeUnited KingdomUnknown status
Western General Hospital /ID# 261106
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EdinburghUnited KingdomUnknown status
Leeds Teaching Hospitals NHS Trust /ID# 261101
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LeedsUnited KingdomUnknown status
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488
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LondonUnited KingdomUnknown status
The Royal Marsden NHS Foundation Trust /ID# 262470
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LondonUnited KingdomUnknown status
The Christie Hospital /ID# 261102
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ManchesterUnited KingdomUnknown status
Nottingham City Hospital /ID# 261105
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NottinghamUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceActive, not recruiting
Alexandra Hospital
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AthensGreeceActive, not recruiting
Evaggelismos Hospital
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AthensGreeceActive, not recruiting
University General Hospital of Thessaloniki - AHEPA
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ThessalonikiGreeceActive, not recruiting
Semmelweis University
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Budapest VIIIHungaryActive, not recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
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GyőrHungaryActive, not recruiting
Shaare Zedek Medical Center /ID# 245681
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JerusalemIsraelUnknown status
Rabin Medical Center. /ID# 245498
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Petah TikvaIsraelUnknown status
The Chaim Sheba Medical Center /ID# 245497
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Ramat GanIsraelUnknown status
Tel Aviv Sourasky Medical Center /ID# 245495
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Ovest Milanese
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LegnanoItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Hyogo Prefectural Amagasaki General Medical Center /ID# 265696
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AmagasakiJapanUnknown status
Anjo Kosei Hospital /ID# 263434
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AnjoJapanUnknown status
Tokyo Metropolitan Komagome Hospital /ID# 277567
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Bunkyo KuJapanUnknown status
Chiba University Hospital /ID# 262006
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ChibaJapanUnknown status
University of Yamanashi Hospital /ID# 262912
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Chuo-shiJapanUnknown status
Kyushu University Hospital /ID# 264704
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FukuokaJapanUnknown status
Chugoku Central Hospital /ID# 263431
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FukuyamaJapanUnknown status
Gifu Municipal Hospital /ID# 263321
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GifuJapanUnknown status
Saitama Prefectural Cancer Center /ID# 262586
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Kitaadachi-gunJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine /ID# 262585
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KyotoJapanUnknown status
Gunma University Hospital /ID# 262580
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MaebashiJapanUnknown status
Nagoya City University Hospital /ID# 263320
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NagoyaJapanUnknown status
Naha City Hospital /ID# 263972
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NahaJapanUnknown status
Miyagi Cancer Center /ID# 265094
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Natori-shiJapanUnknown status
Japanese Red Cross Medical Center /ID# 261717
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Shibuya-kuJapanUnknown status
The University of Osaka Hospital /ID# 263974
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Suita-shiJapanUnknown status
University of Fukui Hospital /ID# 264222
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Yoshida-gunJapanUnknown status
Yonsei University Health System Severance Hospital /ID# 245489
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SeoulSouth KoreaUnknown status
Samsung Medical Center /ID# 245492
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SeoulSouth KoreaUnknown status
Seoul National University Hospital /ID# 245491
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493
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SeoulSouth KoreaUnknown status
Ulsan University Hospital /ID# 245490
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UlsanSouth KoreaUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie
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LublinPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandActive, not recruiting
Hematology And Oncology Institute /ID# 272531
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ManatiPuerto RicoUnknown status
Auxilio Mutuo Cancer Center /ID# 272565
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San JuanPuerto RicoUnknown status
Hospital De Santa Maria E.P.E.
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LisbonPortugalActive, not recruiting
Champalimaud Clinical Centre
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LisbonPortugalActive, not recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalActive, not recruiting
Region Dalarna
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FalunSwedenActive, not recruiting
NU Hospital Group-Vastra Gotalandsregionen
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TrollhattanSwedenActive, not recruiting
China Medical University Hospital /ID# 245483
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital /ID# 261142
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TaichungTaiwanUnknown status
National Taiwan University Hospital /ID# 245482
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TaipeiTaiwanUnknown status
Regents of the University of Michigan /ID# 261577
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Ann ArborUnited StatesUnknown status
Winship Cancer Institute of Emory University /ID# 262525
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AtlantaUnited StatesUnknown status
Our Lady Of The Lake Regional Medical Center /ID# 272780
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Baton RougeUnited StatesUnknown status
New York Cancer & Blood Specialists - Bay Shore /ID# 261524
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Bay ShoreUnited StatesUnknown status
Alta Bates Summit Medical Center for Research /ID# 261438
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BerkeleyUnited StatesUnknown status
Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637
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BethesdaUnited StatesUnknown status
University of Alabama at Birmingham - Main /ID# 261434
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BirminghamUnited StatesUnknown status
Dana-Farber Cancer Institute /ID# 261554
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BostonUnited StatesUnknown status
Beth Israel Deaconess Medical Center /ID# 271535
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BostonUnited StatesUnknown status
University of North Carolina /ID# 259854
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina /ID# 259692
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CharlestonUnited StatesUnknown status
Atrium Health Levine Cancer Institute /ID# 246199
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CharlotteUnited StatesUnknown status
University of Illinois Hospital and Health Sciences System /ID# 246349
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ChicagoUnited StatesUnknown status
Rush University Medical Center /ID# 265690
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ChicagoUnited StatesUnknown status
University Of Cincinnati Medical Center /ID# 246415
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CincinnatiUnited StatesUnknown status
Cleveland Clinic Main Campus /ID# 246183
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ClevelandUnited StatesUnknown status
University of Missouri Hospital /ID# 261553
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ColumbiaUnited StatesUnknown status
Karmanos Cancer Institute - Detroit /ID# 266298
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DetroitUnited StatesUnknown status
Henry Ford Hospital /ID# 262704
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DetroitUnited StatesUnknown status
Duke University Medical Center /ID# 259694
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DurhamUnited StatesUnknown status
Nancy W. Knowles Cancer Center /ID# 271361
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ElmhurstUnited StatesUnknown status
Virginia Cancer Specialists - Fairfax /ID# 262792
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FairfaxUnited StatesUnknown status
Providence - St. Jude Medical Center /ID# 262031
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FullertonUnited StatesUnknown status
Oncology Consultants /ID# 276774
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HoustonUnited StatesUnknown status
Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230
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JacksonvilleUnited StatesUnknown status
Mayo Clinic Hospital Jacksonville /ID# 263324
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JacksonvilleUnited StatesUnknown status
Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891
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LansingUnited StatesUnknown status
VA Loma Linda Healthcare System /ID# 261015
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Loma LindaUnited StatesUnknown status
Rocky Mountain Cancer Centers - Lone Tree /ID# 278320
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Lone TreeUnited StatesUnknown status
Cedars-Sinai Medical Center /ID# 261008
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Los AngelesUnited StatesUnknown status
University of Tennessee Health Science Center /ID# 261622
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MemphisUnited StatesUnknown status
The West Clinic /ID# 262444
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MemphisUnited StatesUnknown status
Baptist Memorial Hospital /ID# 270910
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MemphisUnited StatesUnknown status
Vanderbilt University Medical Center /ID# 261621
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NashvilleUnited StatesUnknown status
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953
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New Hyde ParkUnited StatesUnknown status
New York Cancer and Blood Specialists - New York /ID# 262951
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New YorkUnited StatesUnknown status
Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314
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NorfolkUnited StatesUnknown status
Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772
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OmahaUnited StatesUnknown status
Mayo Clinic Hospital - Phoenix /ID# 263326
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PhoenixUnited StatesUnknown status
Oregon Medical Research Center /ID# 262335
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PortlandUnited StatesUnknown status
VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944
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RichmondUnited StatesUnknown status
Mayo Clinic - Rochester /ID# 246228
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RochesterUnited StatesUnknown status
Springfield Clinic - First /ID# 262266
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SpringfieldUnited StatesUnknown status
Northwest Medical Specialties Tacoma /ID# 276281
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TacomaUnited StatesUnknown status
Eastchester Center for Cancer Care /ID# 262952
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The BronxUnited StatesUnknown status
Texas Oncology - Northeast Texas /ID# 278304
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TylerUnited StatesUnknown status
Constantiaberg Haematology /ID# 261320
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Cape TownSouth AfricaUnknown status
Haemalife Inc. /ID# 245724
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Kuils RiverSouth AfricaUnknown status
Alberts Cellular Therapy /ID# 245725
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PretoriaSouth AfricaUnknown status
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672
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AnkaraTurkey (Türkiye)Unknown status
Antalya Egitim Ve Arastirma Hastanesi /ID# 261674
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AntalyaTurkey (Türkiye)Unknown status
Trakya University Medical Facu /ID# 261673
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Edirne, IstanbulTurkey (Türkiye)Unknown status
Istanbul Florence Nightingale Hospital /ID# 271543
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ŞişliTurkey (Türkiye)Unknown status

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