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-MM 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).
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.
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 after consultation with the GSK medical director.
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 gramdeciliter (gdL), c. Platelet count <50×10^9L, d. Spot urine (albumincreatinine ratio)>500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) <30 milliliter per minute 1.73 meter square (mLmin1.73m^2).

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
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West Palm Beach Florida, 33401, United States More Info
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Shachar Peles
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Kansas City Missouri, 64114, United States More Info
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Jaswinder Singh
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Chattanooga Tennessee, 37404, United States More Info
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Bertrand Anz III
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Nashville Tennessee, 37203, United States More Info
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Jesus G Berdeja
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Houston Texas, 77090, United States More Info
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Saleha Sajid
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Spokane Washington, 99218, United States More Info
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Hakan Kaya
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Capital Federal Buenos Aires, C1426, Argentina More Info
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Paola Ochoa
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Rosario Santa Fe, S2002, Argentina More Info
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Dorotea Fantl
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Adam Bryant
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Waratah New South Wales, 2298, Australia More Info
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Wojciech Janowski
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Woodville South Australia, 5011, Australia More Info
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Huey-Shin Cindy Lee
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Salvador Bahía, 41253, Brazil More Info
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Edvan de Queiroz Crusoe
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Marcelo Bellesso
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Vania Hungria
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Ariah Schattner
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Suzanne Trudel
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Montreal Quebec, H2L 4, Canada More Info
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Emilie Lemieux-Blanchard
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Avignon cedex 9 , 84902, France More Info
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Le Mans , 72000, France More Info
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Nice Cedex 2 , 06189, France More Info
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Orléans , 45100, France More Info
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Saint-Priest en Jarez , 42270, France More Info
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Denis Guyotat
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Karlsruhe Baden-Wuerttemberg, 76133, Germany More Info
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Martin Bentz
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Cottbus Brandenburg, 03048, Germany More Info
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Martin Schmidt-Hieber
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Greifswald Mecklenburg-Vorpommern, 17475, Germany More Info
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Annamaria Brioli
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Oldenburg Niedersachsen, 26133, Germany More Info
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Christoph Kimmich
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Ralf Meyer
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Karolin Trautmann-Grill
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Hans Salwender
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Athens , 106 7, Greece More Info
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Sosana Delimpasi
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Haidari, Athens , 12462, Greece More Info
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Vasiliki Pappa
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Sandip Shah
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Kerala , 68204, India More Info
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Tuphan Kanti Dolai
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Jeevan Kumar
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Sangeeta Jiwatani
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Pondicherry , 60500, India More Info
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Biswajit Dubashi
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Dublin , 8, Ireland More Info
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Patrick Hayden
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Michele Cavo
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Barbara Gamberi
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Patrizia Tosi
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Massimo Roberto Lemoli
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Piero Galieni
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Alessandria Piemonte, 15121, Italy More Info
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Federico Monaco
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Busan , 49241, Korea, Republic of More Info
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Ho-Jin Shin
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Seoul , 03080, Korea, Republic of More Info
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JaMin Byun
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Mexico City Ciudad De Mexico, 03720, Mexico More Info
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Brenda-Leticia Gonzalez-Garcia
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Jaroslaw Czyz
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Agata Tyczynska
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Katowice , 40-51, Poland More Info
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Sebastian Grosicki
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Marek Hus
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Szymon Fornagiel
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Joanna Romejko-Jarosinska
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Tomasz Wrobel
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Ángel Ramírez Payer
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Albacete , 02006, Spain More Info
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Irene Gómez Catalán
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Barcelona , 08026, Spain More Info
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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
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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