Multiple Myeloma Clinical Trial

A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma

Summary

The purpose of this study is to compare the efficacy of talquetamab versus belantamab mafodotin in terms of overall response rate (ORR) or progression-free survival (PFS).

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Full Description

Multiple myeloma is an incurable, malignant, plasma cell disorder that accounts for approximately 18 percent (%) of hematological malignancies, making it the second most common hematologic malignancy. Talquetamab (also known as JNJ-64407564) is a humanized immunoglobulin G4 (IgG4) bispecific antibody designed to target G Protein-coupled receptor family C group 5 member D (GPRC5D+) cells and cluster of differentiation 3 (CD3) receptor complex on T-cells. Belantamab mafodotin is a humanized B-cell maturation antigen (BCMA)-targeting monoclonal antibody (mAb) conjugated to a cytotoxic agent maleimidocaproyl monomethyl auristatin F (MMAF) which disrupts the microtubule network, leading to cell cycle arrest and apoptosis. This study will investigate the possible improvement of ORR or PFS with talquetamab compared with belantamab mafodotin in participants with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 mAb (alone or in combination), and whose disease is refractory to at least one proteasome inhibitor (PI) and one immunomodulatory drug (IMiD). The study will consists of a screening phase, treatment phase (until confirmed progressive disease, start of subsequent antimyeloma therapy, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and post-treatment follow-up phase (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Safety evaluations will include a review of adverse events, physical examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, and vital signs.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Documented multiple myeloma as defined by the criteria: a) multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria b) measurable disease at screening, as assessed by central laboratory, defined by any of the following i) serum M-protein level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) ii) urine M-protein level >=200 milligram (mg)/24 hours iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum free light chain (sFLC) >=10 milligram per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain (FLC) ratio
Received at least 4 prior antimyeloma therapies including an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb) (alone or in combination) and is refractory per IMWG criteria to at least one proteasome inhibitor (PI), and one immunomodulatory drug (IMiD)
Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening
A female participant of childbearing potential must have a negative serum pregnancy test at screening, and must agree to further serum or urine pregnancy tests during the study and within 6 months after receiving the last dose of study treatment

Exclusion Criteria:

Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
Stroke or seizure within 6 months prior to signing informed consent form (ICF)
Prior or concurrent exposure to belantamab mafodotin
Current corneal epithelial disease except mild punctate keratopathy
Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

216

Study ID:

NCT05461209

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 84 Locations for this study

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University of Arizona Cancer Center
Tucson Arizona, 85719, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
University of California, San Francisco
San Francisco California, 94143, United States
Norwalk Hospital-oncology
Norwalk Connecticut, 06850, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
University Of Illinois
Chicago Illinois, 60607, United States
Tulane University Hospital & Clinics
New Orleans Louisiana, 70112, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20814, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Saint Luke's Hospital - Saint Luke's Cancer Specialists
Chesterfield Missouri, 63017, United States
New Jersey Hematology Oncology Ass.
Brick New Jersey, 08724, United States
Novant Health
Charlotte North Carolina, 28204, United States
Novant Health
Winston-Salem North Carolina, 27103, United States
University Hospital of Cleveland
Cleveland Ohio, 44106, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond Virginia, 23298, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53705, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States
Nova Scotia Health Authority
Halifax Nova Scotia, B3H 1, Canada
University Health Network
Toronto Ontario, M5G 1, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
CHU de Québec Université Laval
Quebec , G1R 2, Canada
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultní nemocnice Olomouc
Olomouc , 779 0, Czechia
Fakultni nemocnice Ostrava
Ostrava , 708 5, Czechia
Universitaetsklinikum Frankfurt
Frankfurt , 60590, Germany
Universitaetsklinikum Halle (Saale)
Halle (Saale) , 06120, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel , 24105, Germany
Universitaetsklinikum Koeln
Koeln , 50937, Germany
Klinikum rechts der Isar der TU Muenchen
Muenchen , 81675, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tuebingen , 72076, Germany
Universitaetsklinikum Wuerzburg
Wuerzburg , 97080, Germany
Alexandra General Hospital of Athens
Athens , 11528, Greece
Rambam Medical Center
Haifa , 31096, Israel
Carmel Medical Center
Haifa , 34362, Israel
Rabin Medical Center
Petah Tikva , 49100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Policlinico Sant'Orsola Malpighi
Bologna , 40138, Italy
Asst Ovest Milanese - Ospedale Di Legnano
Legnano , 20025, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , 47014, Italy
Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano
Milano , 20122, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo , 90127, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Azienda Ospedaliera di Perugia Ospedale S.Maria della Misericordia
Perugia , 06129, Italy
A.O. Universitaria Senese- Ospedale Santa Maria alle Scotte
Siena , 53100, Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Torino , 10126, Italy
Hospital Santa Maria della Misericordia
Udine , 33100, Italy
ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi
Varese , 2100, Italy
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów , 36-20, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce , 25-73, Poland
Szpital Kliniczny im. H. Swiecickiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Poznaniu
Poznań , 60-10, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw , 50-36, Poland
Hosp. Garcia de Orta
Almada , 2805-, Portugal
Instituto Portugues de Oncologia
Lisboa , 1099-, Portugal
Champalimaud Foundation Champalimaud Centre
Lisbon , 1400-, Portugal
Instituto Portugues de Oncologia
Porto , 4200-, Portugal
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia , 4434-, Portugal
Hosp. de Cabuenes
Asturias , , Spain
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Clinic I Provincial de Barcelona
Barcelona , 08036, Spain
Hosp. de Leon
Leon , 24080, Spain
Hosp. Univ. de La Princesa
Madrid , 28006, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Hosp. Quiron Madrid Pozuelo
Madrid , 28223, Spain
Hosp. Univ. Virgen de La Arrixaca
Murcia , 30120, Spain
Hosp. Univ. Marques de Valdecilla
Santander , 39008, Spain
Hosp. Gral. Univ. de Toledo
Toledo , 45007, Spain
Hosp. Univ. Dr. Peset
Valencia , 46017, Spain
Belfast City Hospital
Belfast , BT9 7, United Kingdom
Nottingham University Hospitals
Nottingham , NG5 1, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Queen Alexandra Hospital
Porthsmouth , PO6 3, United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

216

Study ID:

NCT05461209

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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