Multiple Myeloma Clinical Trial

Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma

Summary

This study aims to evaluate alternative dosing regimens of single-agent belantamab mafodotin in participants with relapsed or refractory multiple myeloma (RRMM) to determine if an improved overall benefit/risk profile can be achieved by modifying the belantamab mafodotin dose, schedule, or both.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib).
France specific: participants have failed at least 4 prior lines of anti-myeloma therapies
Participant has measurable disease per modified IMWG criteria.
Life expectancy of at least 6 months, in the opinion of the investigator.
Male and female participants agree to abide by protocol-defined contraceptive requirements.
Participant is capable of giving signed informed consent.
Participant meets country-specific inclusion criteria described in the protocol.

Exclusion Criteria:

Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening.
Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK).
Evidence of active mucosal or internal bleeding.
Presence of an active renal condition.
Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures.
Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for >2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction.
Evidence of cardiovascular risk as per the protocol criteria.
Pregnant or lactating female.
Active infection requiring antibiotic, antiviral, or antifungal treatment.
Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met.
Hepatitis B and C will be excluded unless the criteria in protocol can be met.
Cirrhosis or current unstable liver or biliary disease.
Alanine aminotransferase (ALT) >2.5× upper limit of normal (ULN).
Total Bilirubin >1.5×ULN.
Systemic anti-MM therapy within <=14 days or 5 half-lives, whichever is shorter.
Systemic therapy with high dose steroids within <=14 days before the first dose of study treatment.
Prior allogenic stem cell transplant.
Prior treatment with a monoclonal antibody <=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted.
Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment.
Treatment with an antibody-drug conjugate.
Participant has received any major surgery <=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery.
Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count <1.0×10^9/L, b. Hemoglobin <8 gram/deciliter (g/dL), c. Platelet count <50×10^9/L, d. Spot urine (albumin/creatinine ratio) >500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) <30 milliliter per minute per 1.73 meter square (mL/min/1.73m^2).
UK specific: a. Absolute neutrophil count <1.5×10^9/L, c. Platelet count <75×10^9/L

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT05064358

Recruitment Status:

Recruiting

Sponsor:

GlaxoSmithKline

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GSK Investigational Site
New Port Richey Florida, 34655, United States More Info
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Gustaro A Fonseca
Principal Investigator
GSK Investigational Site
West Palm Beach Florida, 33401, United States More Info
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Shachar Peles
Principal Investigator
GSK Investigational Site
Kansas City Missouri, 64114, United States More Info
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Jaswinder Singh
Principal Investigator
GSK Investigational Site
New York New York, 10065, United States More Info
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Malin Hultcrantz
Principal Investigator
GSK Investigational Site
Chattanooga Tennessee, 37404, United States More Info
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Bertrand Anz III
Principal Investigator
GSK Investigational Site
Nashville Tennessee, 37203, United States More Info
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Jesus G Berdeja
Principal Investigator
GSK Investigational Site
Houston Texas, 77090, United States More Info
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Saleha Sajid
Principal Investigator
GSK Investigational Site
Houston Texas, 77090, United States More Info
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Woondong Jeong
Principal Investigator
GSK Investigational Site
Spokane Washington, 99218, United States More Info
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Hakan Kaya
Principal Investigator
GSK Investigational Site
Capital Federal Buenos Aires, C1426, Argentina More Info
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Paola Ochoa
Principal Investigator
GSK Investigational Site
Rosario Santa Fe, S2002, Argentina More Info
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Herman Perroud
Principal Investigator
GSK Investigational Site
Ciudad Autonoma de Buenos Aires , 1414, Argentina More Info
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Vanesa Caruso
Principal Investigator
GSK Investigational Site
Ciudad Autonoma de Buenos Aires , C1181, Argentina More Info
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Dorotea Fantl
Principal Investigator
GSK Investigational Site
Liverpool New South Wales, 2170, Australia More Info
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Adam Bryant
Principal Investigator
GSK Investigational Site
Waratah New South Wales, 2298, Australia More Info
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Wojciech Janowski
Principal Investigator
GSK Investigational Site
Woodville South Australia, 5011, Australia More Info
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Huey-Shin Cindy Lee
Principal Investigator
GSK Investigational Site
East Melbourne Victoria, 3002, Australia More Info
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Miles Prince
Principal Investigator
GSK Investigational Site
Salvador Bahía, 41253, Brazil More Info
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Edvan de Queiroz Crusoe
Principal Investigator
GSK Investigational Site
Curitiba Paraná, 80040, Brazil More Info
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Johnny Francisco Camargo
Principal Investigator
GSK Investigational Site
Porto Alegre Rio Grande Do Sul, 90850, Brazil More Info
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Marcelo Eduardo Capra
Principal Investigator
GSK Investigational Site
Joinville Santa Catarina, 89201, Brazil More Info
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Marcelo Pitombeira de Lacerda
Principal Investigator
GSK Investigational Site
Rio de Janeiro , 22271, Brazil More Info
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Fabio Moore Nucci
Principal Investigator
GSK Investigational Site
São Paulo , 01236, Brazil More Info
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Marcelo Bellesso
Principal Investigator
GSK Investigational Site
São Paulo , 04537, Brazil More Info
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Vania Tietsche Hungria
Principal Investigator
GSK Investigational Site
Oshawa Ontario, L1G 2, Canada More Info
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Ariah Schattner
Principal Investigator
GSK Investigational Site
Toronto Ontario, M5G 2, Canada More Info
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Suzanne Trudel
Principal Investigator
GSK Investigational Site
Montreal Quebec, H2L 4, Canada More Info
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Emilie Lemieux-Blanchard
Principal Investigator
GSK Investigational Site
Montréal Quebec, H4J 1, Canada More Info
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Jean-Samuel Boudreault-Pedneault
Principal Investigator
GSK Investigational Site
Avignon cedex 9 , 84902, France More Info
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Borhane Slama
Principal Investigator
GSK Investigational Site
Le Mans , 72000, France More Info
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Kamel Laribi
Principal Investigator
GSK Investigational Site
Nice Cedex 2 , 06189, France More Info
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Lauris Gastaud
Principal Investigator
GSK Investigational Site
Orléans , 45100, France More Info
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Omar Benbrahim
Principal Investigator
GSK Investigational Site
Saint-Priest en Jarez , 42270, France More Info
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Denis Guyotat
Principal Investigator
GSK Investigational Site
Karlsruhe Baden-Wuerttemberg, 76133, Germany More Info
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Martin Bentz
Principal Investigator
GSK Investigational Site
Cottbus Brandenburg, 03048, Germany More Info
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Martin Schmidt-Hieber
Principal Investigator
GSK Investigational Site
Greifswald Mecklenburg-Vorpommern, 17475, Germany More Info
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Annamaria Brioli
Principal Investigator
GSK Investigational Site
Oldenburg Niedersachsen, 26133, Germany More Info
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Christoph Kimmich
Principal Investigator
GSK Investigational Site
Dortmund Nordrhein-Westfalen, 44137, Germany More Info
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Ralf Meyer
Principal Investigator
GSK Investigational Site
Dresden Sachsen, 01307, Germany More Info
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Karolin Trautmann-Grill
Principal Investigator
GSK Investigational Site
Hamburg , 22763, Germany More Info
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Hans Salwender
Principal Investigator
GSK Investigational Site
Athens , 106 7, Greece More Info
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Sosana Delimpasi
Principal Investigator
GSK Investigational Site
Athens , 11528, Greece More Info
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Meletios Athanasios Dimopoulos
Principal Investigator
GSK Investigational Site
Haidari, Athens , 12462, Greece More Info
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Vasiliki Pappa
Principal Investigator
GSK Investigational Site
Rio/Patras , 26504, Greece More Info
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Argiris S. Symeonidis
Principal Investigator
GSK Investigational Site
Thessaloniki , 57010, Greece More Info
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Ioanna Sakellari
Principal Investigator
GSK Investigational Site
Nashik Maharashtra, 42200, India More Info
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Sandeep Vithoba Ishi
Principal Investigator
GSK Investigational Site
Ahmedabad , 38000, India More Info
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Sandip Shah
Principal Investigator
GSK Investigational Site
Bangalore , 56005, India More Info
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Santhosh Kumar Devadas
Principal Investigator
GSK Investigational Site
Hyderabad , 50003, India More Info
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SVSS Prasad
Principal Investigator
GSK Investigational Site
Kerala , 68204, India More Info
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Neeraj Sidharthan
Principal Investigator
GSK Investigational Site
Kolkata , 70001, India More Info
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Tuphan Kanti Dolai
Principal Investigator
GSK Investigational Site
Kolkata , 70015, India More Info
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Jeevan Kumar
Principal Investigator
GSK Investigational Site
Mumbai , 40007, India More Info
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Sangeeta Jiwatani
Principal Investigator
GSK Investigational Site
Pondicherry , 60500, India More Info
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Biswajit Dubashi
Principal Investigator
GSK Investigational Site
Pune , 41100, India More Info
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Sameer Melinkeri
Principal Investigator
GSK Investigational Site
Dublin , 8, Ireland More Info
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Patrick Hayden
Principal Investigator
GSK Investigational Site
Dublin , D09 V, Ireland More Info
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John Quinn
Principal Investigator
GSK Investigational Site
Bologna Emilia-Romagna, 40138, Italy More Info
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Michele Cavo
Principal Investigator
GSK Investigational Site
Cona (FE) Emilia-Romagna, 44124, Italy More Info
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Antonio Cuneo
Principal Investigator
GSK Investigational Site
Meldola Emilia-Romagna, 47014, Italy More Info
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Michela Ceccolini
Principal Investigator
GSK Investigational Site
Reggio Emilia Emilia-Romagna, 42123, Italy More Info
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Barbara Gamberi
Principal Investigator
GSK Investigational Site
Rimini Emilia-Romagna, 47900, Italy More Info
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Patrizia Tosi
Principal Investigator
GSK Investigational Site
Genova Liguria, 16132, Italy More Info
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Massimo Roberto Lemoli
Principal Investigator
GSK Investigational Site
Ascoli Piceno Marche, 63100, Italy More Info
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Piero Galieni
Principal Investigator
GSK Investigational Site
Alessandria Piemonte, 15121, Italy More Info
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Federico Monaco
Principal Investigator
GSK Investigational Site
Cagliari , 09121, Italy More Info
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Daniele Derudas
Principal Investigator
GSK Investigational Site
Busan , 49241, Korea, Republic of More Info
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Ho-Jin Shin
Principal Investigator
GSK Investigational Site
Hwasun-gun, Jeollanam-do , 58128, Korea, Republic of More Info
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Je-Jung Lee
Principal Investigator
GSK Investigational Site
Seoul , 03080, Korea, Republic of More Info
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JaMin Byun
Principal Investigator
GSK Investigational Site
Seoul , 06591, Korea, Republic of More Info
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Chang Ki Min
Principal Investigator
GSK Investigational Site
Mexico City Ciudad De Mexico, 03720, Mexico More Info
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Aline Guillermina Ramirez-Alvarado
Principal Investigator
GSK Investigational Site
Mexico Ciudad De Mexico, 03100, Mexico More Info
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Brenda-Leticia Gonzalez-Garcia
Principal Investigator
GSK Investigational Site
Bydgoszcz , 85-16, Poland More Info
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Jaroslaw Czyz
Principal Investigator
GSK Investigational Site
Gdansk , 80-21, Poland More Info
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Agata Tyczynska
Principal Investigator
GSK Investigational Site
Katowice , 40-51, Poland More Info
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Sebastian Grosicki
Principal Investigator
GSK Investigational Site
Lublin , 20-08, Poland More Info
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Marek Hus
Principal Investigator
GSK Investigational Site
Nowy Sacz , 33-30, Poland More Info
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Szymon Fornagiel
Principal Investigator
GSK Investigational Site
Walbrzych , 58-30, Poland More Info
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+44 (0) 20 8990 4466
[email protected]
Aleksandra Butrym
Principal Investigator
GSK Investigational Site
Warszawa , 02-78, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Joanna Romejko-Jarosinska
Principal Investigator
GSK Investigational Site
Wroclaw , 50-36, Poland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Tomasz Wrobel
Principal Investigator
GSK Investigational Site
Oviedo Asturias, 33011, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Ángel Ramírez Payer
Principal Investigator
GSK Investigational Site
Albacete , 02006, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Irene Gómez Catalán
Principal Investigator
GSK Investigational Site
Alcorcón (Madrid) , 28922, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Francisco Javier Peñalver Párraga
Principal Investigator
GSK Investigational Site
Barcelona , 08026, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Jordi López Pardo
Principal Investigator
GSK Investigational Site
Cordoba , 14004, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Miguel Ángel Álvarez Rivas
Principal Investigator
GSK Investigational Site
Gerona , 17007, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Yolanda González Montes
Principal Investigator
GSK Investigational Site
Lleida , 25198, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Antonio García Guiñón
Principal Investigator
GSK Investigational Site
Terrassa (Barcelona) , 08221, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Josep María Martí Tutusaus
Principal Investigator
GSK Investigational Site
Valencia , 46010, Spain More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Ana Isabel Teruel Casasús
Principal Investigator
GSK Investigational Site
Bern , 3010, Switzerland More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Thomas Pabst
Principal Investigator
GSK Investigational Site
Taichung , 404, Taiwan More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Su-Peng Yeh
Principal Investigator
GSK Investigational Site
Taichung , 40705, Taiwan More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Tsung-Chih Chen
Principal Investigator
GSK Investigational Site
Tainan , 704, Taiwan More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Tsai-Yun Chen
Principal Investigator
GSK Investigational Site
Taipei , 100, Taiwan More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
SHANG-YI Huang
Principal Investigator
GSK Investigational Site
Taipei , 112, Taiwan More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Chia-Jen Liu
Principal Investigator
GSK Investigational Site
Bangkok , 10210, Thailand More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Aimwipa Sasakul
Principal Investigator
GSK Investigational Site
Bangkok , 10330, Thailand More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Panisinee Lawasut
Principal Investigator
GSK Investigational Site
Chiang Mai , 50200, Thailand More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Lalita Norasetthada
Principal Investigator
GSK Investigational Site
Khon Kaen , 40002, Thailand More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Chinadol Wanitpongpun
Principal Investigator
GSK Investigational Site
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Kamaraj Karunanithi
Principal Investigator
GSK Investigational Site
Leicester , LE1 5, United Kingdom More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Linda Barton
Principal Investigator
GSK Investigational Site
London , SW17 , United Kingdom More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Yasmin Reyal
Principal Investigator
GSK Investigational Site
London , W12 0, United Kingdom More Info
US GSK Clinical Trials Call Center
Contact
877-379-3718
[email protected]
EU GSK Clinical Trials Call Centre
Contact
+44 (0) 20 8990 4466
[email protected]
Aristeidis Chaidos
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

180

Study ID:

NCT05064358

Recruitment Status:

Recruiting

Sponsor:


GlaxoSmithKline

How clear is this clinincal trial information?

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