Multiple Myeloma Clinical Trial
A Study to Compare Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) in Participants With Newly Diagnosed Multiple Myeloma
Summary
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
Full Description
Teclistamab is a full-size, immunoglobin G4 proline, alanine, alanine (IgG4-PAA) bispecific antibody that targets the cluster of differentiation 3 (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA), which is expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B cells and plasma cells. DRd is an approved regimen for the treatment of participants with newly diagnosed, transplant-ineligible multiple myeloma. The primary hypothesis of this study is that Tec-DR will significantly improve the rate of progression free survival (PFS) or sustained minimal residual disease (MRD)-negative complete response (CR) compared with DRd in participants with newly diagnosed multiple myeloma who are ineligible or not intended for autologous stem cell transplant (ASCT) as initial therapy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up. Safety Assessment includes adverse events (AEs), laboratory test results, vital sign measurements, physical examination findings, assessment of Eastern Cooperative Oncology Group (ECOG) performance status grade, and effector cell associated encephalopathy (ICE) score (Tec-DR only). Total duration of this study will be up to 9 years.
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 female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study treatment
A male participant must agree not to plan to father a child while enrolled in this study or within 3 months after the last dose of study treatment
Exclusion Criteria:
Received a cumulative dose of systemic corticosteroids equivalent to greater than or equal to (>=) 20 milligrams (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 excipients
Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
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There are 183 Locations for this study
Tucson Arizona, 85719, United States
Irvine California, 92618, United States
La Jolla California, 92037, United States
Farmington Connecticut, 06030, United States
Washington District of Columbia, 20007, United States
Weston Florida, 33331, United States
Augusta Georgia, 30912, United States
Shreveport Louisiana, 71103, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02118, United States
Detroit Michigan, 48202, United States
Southfield Michigan, 48075, United States
Saint Louis Missouri, 63110, United States
Camden New Jersey, 08103, United States
New Brunswick New Jersey, 08901, United States
New York New York, 10065, United States
New York New York, 10065, United States
Stony Brook New York, 11794, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27705, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97239, United States
Allentown Pennsylvania, 18103, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Fort Belvoir Virginia, 22060, United States
Seattle Washington, 98109, United States
Camperdown , 2050, Australia
Geelong , 3220, Australia
Liverpool , 2170, Australia
Murdoch , 6150, Australia
Nedlands , 6009, Australia
New South Wales , 2298, Australia
Wollongong , 2500, Australia
Woolloongabba , 4102, Australia
Linz , 1140, Austria
Salzburg , 5020, Austria
Vienna , 1090, Austria
Wien , 1140, Austria
Anderlecht , 1070, Belgium
Haine-Saint-Paul, La Louviere , 7100, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Belo Horizonte, Minas Gerais , 30150, Brazil
Fortaleza , 60430, Brazil
Natal , 59062, Brazil
Niteroi , 24030, Brazil
Ribeirao Preto , 14051, Brazil
Salvador , 41235, Brazil
Sao Paulo , 04537, Brazil
Sao Paulo , 05403, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Vancouver British Columbia, V5Z4E, Canada
Hamilton Ontario, L8V5C, Canada
Ottawa Ontario, K1H 8, Canada
Quebec , G1R 2, Canada
Beijing , 10002, China
Beijing , 10003, China
Changsha , 41001, China
Chengdu , 61007, China
Fu Zhou , 35000, China
Guangzhou , 51006, China
Guangzhou , 51051, China
Hang Zhou , 31000, China
Hangzhou , 31000, China
Nanjing , 21000, China
Shanghai , 20002, China
Shenyang , 11005, China
Tian Jin , 30002, China
Tianjin , 30006, China
Wenzhou , 32500, China
Xi' An , 71000, China
Zhengzhou , 45000, China
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Olomouc , 779 0, Czechia
Ostrava , 708 5, Czechia
Plzen , 304 6, Czechia
Praha , 128 0, Czechia
Aalborg , 9000, Denmark
Herning , 7400, Denmark
Roskilde , , Denmark
Vejle , 7100, Denmark
Creteil , 94010, France
Dijon , 21000, France
Lille , 59000, France
Nantes , 44093, France
PARIS cedex 12 , 75012, France
Pessac cedex , 33604, France
Pierre-Benite , 69310, France
Poitiers , 86021, France
Rennes , 35033, France
Toulouse , 31000, France
Berlin , 13125, Germany
Dortmund , 44137, Germany
Hamburg , 20251, Germany
Mainz , 55131, Germany
Nuernberg , 90419, Germany
Tübingen , 72076, Germany
Würzburg , 97080, Germany
Athens Attica , 115 2, Greece
Thessalonikis , 570 1, Greece
Thessaloniki , 546 3, Greece
Budapest , 1088, Hungary
Budapest , 1097, Hungary
Budapest , 1122, Hungary
Pécs , 7624, Hungary
Bangalore , 56005, India
Bombay , 40001, India
Chandigarh , 16001, India
Gurugram , 12200, India
Jaipur , 30201, India
Kolkata , 70016, India
Nagpur , 44000, India
New Delhi , 11002, India
Pondicherry , 60500, India
Pune , 41100, India
Bologna , 40138, Italy
Milan , 20132, Italy
Naples , 80131, Italy
Pavia , 27100, Italy
Roma , 00133, Italy
Rozzano , 20089, Italy
Torino , 10126, Italy
Bunkyo-Ku , 113-8, Japan
Chiba , 296-0, Japan
Higashiibaraki-gun , 311-3, Japan
Hirakata , 573-1, Japan
Hyôgo , 663-8, Japan
Iruma-gun , 350-0, Japan
Kanagawa , 259-1, Japan
Kumamoto-shi , 860-8, Japan
Matsuyama-City , 790-8, Japan
Nagasaki , 856-8, Japan
Okayama , 701-1, Japan
Osaka , 545-8, Japan
Sapporo-shi , 060-8, Japan
Shibuya-ku , 150-8, Japan
Sunto-gun , 411-8, Japan
Toyoake , 470-1, Japan
Yamanashi , 400-8, Japan
Busan , 49241, Korea, Republic of
Daegu , 41944, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Incheon , 21565, Korea, Republic of
Amsterdam , 1081 , Netherlands
Apeldoorn , 7334 , Netherlands
Nieuwegein , 3435 , Netherlands
Sittard , 6130 , Netherlands
Oslo , 0450, Norway
Trondheim , 7030, Norway
Brzozow , 36-20, Poland
Katowice , 40-08, Poland
Kielce , 25-73, Poland
Krakow , 30-50, Poland
Olsztyn , 10-22, Poland
Almada , 2805-, Portugal
Braga , 4710-, Portugal
Lisbon , 1400-, Portugal
Porto , 4200-, Portugal
Granada , 18014, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Madrid , 28050, Spain
Palma de Mallorca , 07120, Spain
Salamanca , 37007, Spain
Terrassa , 08221, Spain
Valencia , 46010, Spain
Falun , 791 8, Sweden
Lund , 221 8, Sweden
Stockholm , 141 8, Sweden
Örebro , 701 8, Sweden
Bern , 3010, Switzerland
St. Gallen , 9007, Switzerland
Ankara , 06590, Turkey
Istanbul , 34093, Turkey
Istanbul , 34214, Turkey
Izmir , 35340, Turkey
Samsun , 55280, Turkey
Blackpool , FY3 8, United Kingdom
Cambridge , CB2 0, United Kingdom
Canterbury , CT1 3, United Kingdom
Edinburgh , EH4 2, United Kingdom
Leeds , LS9 7, United Kingdom
London , SE1 9, United Kingdom
London , W2 1N, United Kingdom
Wolverhampton , WV10 , United Kingdom
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