A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Sep 21, 2022
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two combinations of medications for patients with newly diagnosed multiple myeloma, a type of blood cancer. The combinations being tested are teclistamab with daratumumab and lenalidomide (Tec-DR) and talquetamab with daratumumab and lenalidomide (Tal-DR). The goal is to see how well these combinations work compared to the standard treatment of daratumumab, lenalidomide, and dexamethasone (DRd).
To participate in this study, patients must be newly diagnosed with multiple myeloma and not eligible for high-dose chemotherapy with stem cell transplant due to age or other health conditions. They should also be between the ages of 65 and 74 and meet other criteria related to their health status. Participants can expect to receive one of the treatment combinations and will be monitored closely for effectiveness and side effects. It's important to note that women who are pregnant or breastfeeding, as well as men planning to father a child, will need to avoid participation due to safety concerns. This trial is currently recruiting participants, and it aims to find better treatment options for individuals facing this challenging condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
- • Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
- • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- • A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
- • A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
- Exclusion Criteria:
- • Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization
- • Had plasmapheresis within 28 days of randomization
- • Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
- • Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
- • Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
- • Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Durham, North Carolina, United States
Boston, Massachusetts, United States
Saint Louis, Missouri, United States
Edmonton, Alberta, Canada
New York, New York, United States
Seattle, Washington, United States
Vejle, , Denmark
Washington, District Of Columbia, United States
Boston, Massachusetts, United States
Omaha, Nebraska, United States
Dallas, Texas, United States
Stony Brook, New York, United States
London, , United Kingdom
Portland, Oregon, United States
Rozzano, , Italy
Southfield, Michigan, United States
Woolloongabba, Queensland, Australia
Kortrijk, , Belgium
Ottawa, Ontario, Canada
Farmington, Connecticut, United States
Nedlands, , Australia
Porto Alegre, , Brazil
Houston, Texas, United States
Milan, , Italy
Nantes, , France
Yamanashi, , Japan
Trondheim, , Norway
Seoul, , Korea, Republic Of
Blackpool, , United Kingdom
Turku, , Finland
Tucson, Arizona, United States
Stockholm, , Sweden
Edinburgh, , United Kingdom
Oulu, , Finland
Louisville, Kentucky, United States
New York, New York, United States
Ramat Gan, , Israel
Cambridge, Cambridgeshire, United Kingdom
Wolverhampton, , United Kingdom
Vienna, , Austria
Beijing, Beijing, China
Seoul, , Korea, Republic Of
Gothenburg, , Sweden
New Delhi, , India
Santa Fe, New Mexico, United States
Aalborg, , Denmark
Leeds, , United Kingdom
New Haven, Connecticut, United States
Camperdown, , Australia
Woolloongabba, , Australia
Gent, , Belgium
Firenze, , Italy
Dijon, , France
Busan, , Korea, Republic Of
Falun, , Sweden
Stockholm, , Sweden
Seoul, , Korea, Republic Of
Cambridge, , United Kingdom
Nantes, , France
Hirakata, , Japan
Salamanca, , Spain
Duarte, California, United States
Durham, North Carolina, United States
Allentown, Pennsylvania, United States
Kanagawa, , Japan
Beijing, , China
Budapest, , Hungary
New Brunswick, New Jersey, United States
Charlotte, North Carolina, United States
Okayama, , Japan
Bern, , Switzerland
Cleveland, Ohio, United States
Wollongong, , Australia
Leuven, , Belgium
Hradec Kralove, , Czechia
Lublin, , Poland
Harbin, , China
Jerusalem, , Israel
Goyang Si, , Korea, Republic Of
Incheon, , Korea, Republic Of
Liverpool, , Australia
Hwasun, , Korea, Republic Of
Brno, , Czechia
Mainz, , Germany
Budapest, , Hungary
Nuernberg, , Germany
örebro, , Sweden
Daegu, , Korea, Republic Of
Beijing, Beijing, China
Ostrava, , Czechia
Shenyang, Liaoning, China
Nieuwegein, , Netherlands
Fort Belvoir, Virginia, United States
Kanazawa, , Japan
Zhengzhou, Henan, China
Tianjin, , China
Jinan, Shandong, China
Nanjing, , China
Lille, , France
Hamilton, Ontario, Canada
Hwasun, , Korea, Republic Of
Omaha, Nebraska, United States
Helsinki, , Finland
Anderlecht, , Belgium
Chengdu, , China
Dortmund, , Germany
Delft, , Netherlands
Pierre Benite, , France
Shanghai, , China
Haifa, , Israel
Amsterdam, , Netherlands
Pessac Cedex, , France
Istanbul, , Turkey
Canterbury, , United Kingdom
Vancouver, British Columbia, Canada
Wien, , Austria
Busan, , Korea, Republic Of
Murdoch, , Australia
Salzburg, , Austria
Brzozow, , Poland
Thessalonikis, , Greece
Sapporo Shi, , Japan
Bunkyo Ku, , Japan
Xiamen, , China
Higashiibaraki Gun, , Japan
London, , United Kingdom
Katowice, , Poland
Natal, , Brazil
Olomouc, , Czechia
St. Gallen, , Switzerland
Zhengzhou, , China
Beijing, , China
Creteil, , France
Changchun, Jilin, China
Sittard Geleen, , Netherlands
Augusta, Georgia, United States
Izmir, , Turkey
Würzburg, , Germany
Wilrijk, , Belgium
Toulouse, , France
Chandigarh, , India
Madrid, , Spain
Valencia, , Spain
Sao Paulo, , Brazil
Porto, , Portugal
Poitiers, , France
Seoul, , Korea, Republic Of
Lund, , Sweden
Madrid, , Spain
Katowice, , Poland
Seoul, , Korea, Republic Of
Badalona, , Spain
Bombay, , India
Barcelona, , Spain
Madrid, , Spain
Osaka, , Japan
Olomouc, Olomoucký Kraj, Czechia
Toyoake, , Japan
Plzen, , Czechia
Sunto Gun, , Japan
Rennes, , France
Matsuyama City, , Japan
Roskilde, , Denmark
Bangalore, , India
Shanghai, , China
Zürich, , Switzerland
Linz, , Austria
Pune, , India
Iruma Gun, , Japan
Guangzhou, , China
Sao Paulo, , Brazil
Palma De Mallorca, , Spain
Pondicherry, , India
São Paulo, , Brazil
Wenzhou, , China
Tübingen, , Germany
Budapest, , Hungary
Olomouc, , Czechia
Athens Attica, , Greece
Shibukawa, , Japan
Bydgoszcz, , Poland
Granada, , Spain
Pozuelo De Alarcon, , Spain
Salvador, , Brazil
Calgary, Alberta, Canada
Berlin, , Germany
Apeldoorn, , Netherlands
Oslo, , Norway
Torino, , Italy
Bern, , Switzerland
Nagasaki, , Japan
Terrassa, , Spain
Geelong, , Australia
Nanchang, , China
Pécs, , Hungary
Sapporo, , Japan
Lisbon, , Portugal
Birmingham, , United Kingdom
Shreveport, Louisiana, United States
Haine Saint Paul, La Louviere, , Belgium
Jaipur, , India
Antalya, , Turkey
Quebec, , Canada
Chongqing, Chongqing, China
Ankara, , Turkey
Kielce, , Poland
Krakow, , Poland
Rennes, , France
Jerez De La Frontera, , Spain
Nagpur, , India
Almada, , Portugal
Braga, , Portugal
Bristol, , United Kingdom
St. Gallen, , Switzerland
örebro, , Sweden
Thessaloniki, , Greece
Roma, , Italy
Sittard, , Netherlands
Torino, , Italy
Changsha, , China
Pavia, , Italy
Istanbul, , Turkey
Detroit, Michigan, United States
Bologna, , Italy
Kolkata, , India
Herning, , Denmark
Hamburg, , Germany
Guangzhou, , China
Shibuya Ku, , Japan
Niteroi, , Brazil
Hangzhou, , China
Hyôgo, , Japan
Wurzburg, , Germany
Shenyang, , China
Ankara, , Turkey
Seoul, , Korea, Republic Of
La Jolla, California, United States
Camden, New Jersey, United States
New South Wales, , Australia
Linz, , Austria
Belo Horizonte, Minas Gerais, , Brazil
Fortaleza, , Brazil
Ribeirao Preto, , Brazil
Fu Zhou, , China
Hang Zhou, , China
Tian Jin, , China
Xi' An, , China
Praha, , Czechia
Paris Cedex 12, , France
Gurugram, , India
Naples, , Italy
Olsztyn, , Poland
Samsun, , Turkey
London, , United Kingdom
Irvine, California, United States
Bunkyo Ku, , Japan
Chiba, , Japan
Kumamoto Shi, , Japan
Barretos, , Brazil
Ribeirão Preto, , Brazil
Ribeirao Preto, , Brazil
Pessac Cedex, , France
Curitiba, , Brazil
Ribeirao Preto, , Brazil
Yamagata, , Japan
Sao Paulo, , Brazil
Poznan, , Poland
Weston, Florida, United States
Herning, , Denmark
Chaoyang District, , China
Brno Bohunice, , Czechia
Oslo, , Norway
Goyang Si, , Korea, Republic Of
Strasbourg, , France
Niteroi, , Brazil
Brzozow, , Poland
Thessalonikis, , Greece
Ankara, , Turkey
Chengdu, , China
Bologna, , Italy
Osaka, , Japan
Thessaloniki, , Greece
Ribeirao Preto, , Brazil
Bergamo, , Italy
Bunkyo Ku, , Japan
Tel Aviv Yafo, , Israel
Poitiers, , France
Shanghai, , China
Tian Jin, , China
Grand Rapids, Michigan, United States
Quebec, , Canada
Shanghai, , China
Lodz, , Poland
Halle (Saale), , Germany
Sao Paulo, , Brazil
Seoul, , Korea, Republic Of
Salamanca, , Spain
Calgary, Alberta, Canada
Haine Saint Paul La Louviere, , Belgium
Guangzhou, , China
Wuhan, , China
Paris Cedex 12, , France
Petah Tikva, , Israel
Roma, , Italy
Porto, , Portugal
Barcelona, , Spain
Madrid, , Spain
Salzburg, , Austria
Belo Horizonte, , Brazil
Chiba, , Japan
Porto, , Portugal
Denizli, , Turkey
Curitiba, , Brazil
Katowice, , Poland
Sao Paulo, , Brazil
Chang Zhou, , China
Nan Jing, , China
Nan Ning Shi, , China
Chiba, , Japan
Des Moines, Iowa, United States
Barretos, , Brazil
Hirakata, , Japan
Shen Zhen Shi, , China
Zielona Gora, , Poland
Porto, , Portugal
Braga, , Portugal
Porto Alegre, , Brazil
Hang Zhou, , China
Calgary, Alberta, Canada
Kanazawa, , Japan
Biala Podlaska, , Poland
Calgary, Alberta, Canada
Sunto Gun, , Japan
Kielce, , Poland
Lublin, , Poland
Beijing, , China
Yamagata, , Japan
Antwerpen, , Belgium
Waukee, Iowa, United States
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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