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).

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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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

1030

Study ID:

NCT05552222

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 172 Locations for this study

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City of Hope Orange County Lennar Foundation Cancer Center
Irvine California, 92618, United States
University of California San Diego (UCSD) - The Rebecca and John Moores Cancer Center
La Jolla California, 92037, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
LSUHSC Shreveport Feist-Weiller Cancer Center
Shreveport Louisiana, 71103, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Boston University School Of Medicine
Boston Massachusetts, 02118, United States
Henry Ford Hospital - Hematology/oncology
Detroit Michigan, 48202, United States
Providence Cancer Center
Southfield Michigan, 48075, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Cooper Health System MD Anderson Cancer Center at Cooper
Camden New Jersey, 08103, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell Medical College
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Durham VAMC
Durham North Carolina, 27705, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Lehigh Valley Health Network
Allentown Pennsylvania, 18103, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Fort Belvoir Community Hospital
Fort Belvoir Virginia, 22060, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Royal Prince Alfred Hospital
Camperdown , 2050, Australia
Barwon Health - University Hospital Geelong
Geelong , 3220, Australia
Liverpool Hospital
Liverpool , 2170, Australia
Fiona Stanley Hospital
Murdoch , 6150, Australia
Sir Charles Gairdner Hospital
Nedlands , 6009, Australia
Calvary Mater Newcastle Hospital
New South Wales , 2298, Australia
Wollongong Hospital
Wollongong , 2500, Australia
Ordensklinikum Linz GmbH Elisabethinen
Linz , 5020, Austria
LKH - Universitätsklinikum der PMU Salzburg
Salzburg , 5020, Austria
Medical University Vienna
Vienna , 1090, Austria
Hanusch Krankenhaus
Wien , 1140, Austria
Institut Jules Bordet
Anderlecht , 1070, Belgium
Jolimont
Haine-Saint-Paul, La Louviere , 7100, Belgium
Az Groeninge
Kortrijk , 8500, Belgium
Universitair Ziekenhuis Leuven
Leuven , 3000, Belgium
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk , 2610, Belgium
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais , 30150, Brazil
Instituto Do Cancer Do Ceara
Fortaleza , 60430, Brazil
Liga Norte Riograndense Contra O Cancer
Natal , 59062, Brazil
Complexo Hospitalar de Niterói
Niteroi , 24030, Brazil
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
Ribeirão Preto , 14048, Brazil
Hospital Sao Rafael
Salvador , 41235, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
Sao Paulo , 05403, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Tom Baker Cancer Center, University of Calgary
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
British Columbia Cancer Agency
Vancouver British Columbia, V5Z4E, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V5C, Canada
The Ottawa Hospital - General Campus
Ottawa Ontario, K1H 8, Canada
CHU de Québec Université Laval
Quebec , G1R 2, Canada
Beijing Chaoyang Hospital
Beijing , 10002, China
Peking University First Hospital
Beijing , 10003, China
The Second Xiangya Hospital of Central South Hospital
Changsha , 41001, China
Sichuan Provincial People's Hospital
Chengdu , 61007, China
Fujian Meidical University Union Hospital
Fu Zhou , 35000, China
Sun Yat -Sen University Cancer Center
Guangzhou , 51006, China
Nanfang Hospital
Guangzhou , 51051, China
First Affiliated Hospital, Medical School of Zhejiang University
Hang Zhou , 31000, China
Nanjing Drum Tower Hospital
Nanjing , 21000, China
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai , 20002, China
Shengjing Hospital of China Medical University
Shenyang , 11005, China
Institute of Hematology & Blood Diseases Hospital
Tian Jin , 30002, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , 32500, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi' An , 71000, China
Henan Cancer Hospital
Zhengzhou , 45000, China
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
Fakultni nemocnice Plzen
Plzen , 304 6, Czechia
VFN v Praze
Praha , 128 0, Czechia
Aalborg University Hospital
Aalborg , 9000, Denmark
Regionshospitalet Gødstrup
Herning , 7400, Denmark
Zealand University Hospital
Roskilde , , Denmark
Vejle Sygehus
Vejle , 7100, Denmark
APHP - Hopital Henri Mondor
Creteil , 94010, France
CHU Dijon
Dijon , 21000, France
Hopital Claude Huriez
Lille , 59000, France
CHU Nantes
Nantes , 44093, France
CHU Hôpital Saint Antoine
PARIS cedex 12 , 75012, France
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac cedex , 33604, France
CHU Lyon Sud
Pierre-Benite , 69310, France
CHU Poitiers - Hôpital la Milétrie
Poitiers , 86021, France
CHU de Rennes - Hopital Pontchaillou
Rennes , 35033, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse , 31000, France
Helios Kliniken Berlin Buch Gmbh
Berlin , 13125, Germany
St. Johannes-Hospital
Dortmund , 44137, Germany
Universitaetsklinik Hamburg-Eppendorf
Hamburg , 20251, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz , 55131, Germany
Klinikum Nuernberg Nord
Nuernberg , 90419, Germany
Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
Tübingen , 72076, Germany
Universitaetsklinikum Wuerzburg
Würzburg , 97080, Germany
Alexandra General Hospital of Athens
Athens Attica , 115 2, Greece
'G. Papanikolaou' Hospital of Thessaloniki
Thessalonikis , 570 1, Greece
Anticancer Hospital of Thessaloniki 'Theageneio'
Thessaloniki , 546 3, Greece
Semmelweis Egyetem
Budapest , 1088, Hungary
Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely
Budapest , 1097, Hungary
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs , 7624, Hungary
M S Ramaiah Medical College and Hospital
Bangalore , 56005, India
Tata Memorial Hospital
Bombay , 40001, India
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh , 16001, India
Fortis Memorial Research Institute
Gurugram , 12200, India
Bhagwan Mahaveer Hospital & Research Centre
Jaipur , 30201, India
Tata Medical Center
Kolkata , 70016, India
Kingsway Hospital
Nagpur , 44000, India
All India Institute of Medical Sciences
New Delhi , 11002, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry , 60500, India
Deenanath Mangeshkar Hospital and Research Centre
Pune , 41100, India
A.O.U Sant'Orsola-Malpighi
Bologna , 40138, Italy
Ospedale San Raffaele
Milan , 20132, Italy
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
Naples , 80131, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia , 27100, Italy
Universita Degli Studi di Roma 'Tor Vergata'
Roma , 00133, Italy
Istituto Clinico Humanitas
Rozzano , 20089, Italy
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Torino , 10126, Italy
Juntendo University Hospital
Bunkyo-Ku , 113-8, Japan
Kameda General Hospital
Chiba , 296-0, Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun , 311-3, Japan
Kansai Medical University Hospital
Hirakata , 573-1, Japan
Hyogo Medical University Hospital
Hyôgo , 663-8, Japan
Saitama Medical University Hospital
Iruma-gun , 350-0, Japan
Tokai University Hospital
Kanagawa , 259-1, Japan
Kumamoto University Hospital
Kumamoto-shi , 860-8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
Hokkaido University Hospital
Sapporo-shi , 060-8, Japan
Japanese Red Cross Medical Center
Shibuya-ku , 150-8, Japan
Shizuoka Cancer Center
Sunto-gun , 411-8, Japan
Yamanashi Prefectural Central Hospital
Yamanashi , 400-8, Japan
Pusan National University Hospital
Busan , 49241, Korea, Republic of
Kyungpook National University Hospital
Daegu , 41944, Korea, Republic of
National Cancer Center
Goyang-si , 10408, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
VUMC Amsterdam
Amsterdam , 1081 , Netherlands
Gelre Ziekenhuis
Apeldoorn , 7334 , Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein , 3435 , Netherlands
Zuyderland Medical Center
Sittard , 6130 , Netherlands
Oslo University Hospital HF Ullevål sykehus
Oslo , 0450, Norway
St. Olavs Hospital
Trondheim , 7030, Norway
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozow , 36-20, Poland
Centrum Medyczne Pratia Katowice
Katowice , 40-08, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce , 25-73, Poland
Szpital Uniwersytecki w Krakowie
Krakow , 30-50, Poland
SPZOZ Ministerstwa Spraw Wewnętrznych z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn , 10-22, Poland
Hosp. Garcia de Orta
Almada , 2805-, Portugal
Ccab - Hosp. de Braga
Braga , 4710-, Portugal
Champalimaud Foundation Champalimaud Centre
Lisbon , 1400-, Portugal
Instituto Portugues de Oncologia
Porto , 4200-, Portugal
Hosp. Univ. Virgen de Las Nieves
Granada , 18014, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. La Paz
Madrid , 28046, Spain
Hosp. Univ. Hm Sanchinarro
Madrid , 28050, Spain
Hosp. Univ. Son Espases
Palma de Mallorca , 07120, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Mutua Terrassa
Terrassa , 08221, Spain
Hosp. Clinico Univ. de Valencia
Valencia , 46010, Spain
Falu Lasarett
Falun , 791 8, Sweden
Skanes universitetssjukhus
Lund , 221 8, Sweden
Karolinska University Hospital, Huddinge
Stockholm , 141 8, Sweden
Universitetssjukhuset Örebro
Örebro , 701 8, Sweden
INSELSPITAL, Universitätsspital Bern
Bern , 3010, Switzerland
Kantonsspital St.Gallen
St. Gallen , 9007, Switzerland
Ankara University Medical Faculty
Ankara , 06590, Turkey
Istanbul University Istanbul Medical Faculty
Istanbul , 34093, Turkey
Medipol University Hospital
Istanbul , 34214, Turkey
Dokuz Eylul University Medical Faculty
Izmir , 35340, Turkey
Ondokuz Mayis University
Samsun , 55280, Turkey
Blackpool Victoria Hospital
Blackpool , FY3 8, United Kingdom
Addenbrooke's Hospital
Cambridge , CB2 0, United Kingdom
Kent and Canterbury Hospital
Canterbury , CT1 3, United Kingdom
Western General Hospital
Edinburgh , EH4 2, United Kingdom
St James University Hospital
Leeds , LS9 7, United Kingdom
Guy's Hospital
London , SE1 9, United Kingdom
Imperial College Healthcare
London , W2 1N, 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:

1030

Study ID:

NCT05552222

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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