A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd)... | NCT05083169 | Trialant

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd)... | NCT05083169 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level >=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain >=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio

Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion

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 score of 0, 1, or 2 at screening and prior to the start of administration of study treatment

Have clinical laboratory values within the specified range

Exclusion Criteria:

Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include:

A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG,

A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade >= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization

Received any prior B cell maturation antigen (BCMA)-directed therapy

Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG

Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within 14 days before randomization

Received a live, attenuated vaccine within 4 weeks before randomization

Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis

University of Alabama Birmingham

Birmingham, Alabama 35294, United States

City of Hope

Duarte, California 91010, United States

Stanford University Medical Center

Stanford, California 94305-5623, United States

Yale University

New Haven, Connecticut 06510, United States

Emory University Winship Cancer Institute

Atlanta, Georgia 30322, United States

Tufts Medical Center

Boston, Massachusetts 02111, United States

Henry Ford Hospital

Detroit, Michigan 48202, United States

Henry Ford Health System

Southfield, Michigan 48075, United States

Cleveland Clinic

Cleveland, Ohio 44195, United States

West Penn Hospital

Pittsburgh, Pennsylvania 15224, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15232, United States

Medical University of South Carolina

Charleston, South Carolina 29425-8900, United States

Baptist Cancer Center

Memphis, Tennessee 38120, United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee 37232, United States

University of Texas Southwestern Medical Center

Dallas, Texas 75235, United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112, United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin 53792, United States

Hospital Italiano de Buenos Aires

Buenos Aires, C1199ABB, Argentina

Hospital Aleman

CABA, C1118AAT, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, X5016KEH, Argentina

ZAS Cadix

Antwerp, 2030, Belgium

AZ St.-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

UZ Gent

Ghent, 9000, Belgium

Hopital de Jolimont

Haine Saint Paul La Louviere, 7100, Belgium

Az Groeninge

Kortrijk, 8500, Belgium

UZ Leuven

Leuven, 3000, Belgium

Algemeen Ziekenhuis Delta

Roeselare, 8800, Belgium

Hospitais Integradaos da Gavea S/A - DF Star

Brasília, 70390-140, Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, 81520 060, Brazil

Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN

Florianópolis, 88034-000, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, 59062 000, Brazil

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, 90050-170, Brazil

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, 22775 001, Brazil

Hospital Sao Rafael

Salvador, 41253-190, Brazil

Real e Benemerita Associacao Portuguesa de Beneficencia

São Paulo, 01323 900, Brazil

Hospital Paulistano

São Paulo, 01323-000, Brazil

Clinica Medica Sao Germano S/S LTDA

São Paulo, 01455 010, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, 4501000, Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2, Canada

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2, Canada

BC Cancer Agency - Vancouver BC

Vancouver, British Columbia V5Z 4E6, Canada

QEII Health Sciences

Halifax, Nova Scotia B3H 2Y9, Canada

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario M5G 1X6, Canada

Peking University First Hospital

Beijing, 100034, China

Peking University People's Hospital

Beijing, 100044, China

Peking University Third Hospital

Beijing, 100191, China

The First Hospital of Jilin University

Changchun, 130021, China

The Third Xiangya Hospital of Central Sourth University

Changshashi, 410013, China

Beijing Chaoyang Hospital

Chaoyang District, 100020, China

West China Hospital Sichuan University

Chengdu, 610041, China

Fujian Meidical University Union Hospital

Fuzhou, 350001, China

Sun Yat -Sen University Cancer Center

Guangzhou, 511363, China

First affiliated Hospital of Zhejiang University 1

Hangzhou, 310003, China

First affiliated Hospital of Zhejiang University

Hangzhou, 310003, China

Zhongda Hospital Southeast University

Nanjing, 210009, China

First Affiliated Hospital of Guangxi Medical University

Nanning, 530021, China

Shanghai Zhongshan Hospital

Shanghai, 200032, China

Shengjing Hospital Of China Medical University

Shenyang, 110136, China

Peking University Shenzhen Hospital

Shenzhen, 518036, China

Tianjin Medical University General Hospital

Tianjin, 300011, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, 710004, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, 221000, China

Henan Cancer Hospital

Zhengzhou, 450008, China

Aalborg University Hospital

Aalborg, DK-9000, Denmark

Aarhus University Hospital

Aarhus N, DK-8200, Denmark

Rigshospitalet

Copenhagen, 2100, Denmark

Odense Universitets Hospital

Odense, 5000, Denmark

Vejle Hospital

Vejle, DK-7100, Denmark

CHU Henri Mondor

Créteil, 94000, France

Hopital Claude Huriez

Lille, 59000, France

CHU de Limoges Hopital Dupuytren

Limoges, 87042, France

Hospices Civils de Lyon HCL

Lyon, 69002, France

C.H.U. Hotel Dieu - France

Nantes, 44093, France

CHU De Poitiers

Poitiers, 86021, France

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67200, France

Pôle IUC Oncopole CHU

Toulouse, 31059, France

CHRU Hôpital Bretonneau

Tours, 37044, France

Universitätsklinikum Carl-Gustav-Carus Dresden

Dresden, 01307, Germany

Heinrich-Heine -Universitaet Duesseldorf

Düsseldorf, 40225, Germany

Evang. Krankenhaus Essen-Mitte gGmbH

Essen, 45239, Germany

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

St. Barbara-Klinik Hamm GmbH

Hamm, 59073, Germany

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Universitaetsklinikum Schleswig Holstein Campus Kiel

Kiel, 24105, Germany

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Alexandra General Hospital of Athens

Athens Attica, 115 28, Greece

Anticancer Hospital of Thessaloniki Theageneio

Thessaloniki, 546 39, Greece

G.Papanikolaou

Thessaloniki, 57010, Greece

U.O. Ematologia con Trapianto- AOU Policlinico di Bari

Bari, 70124, Italy

ASST Papa Giovanni XXIII Bergamo

Bergamo, 24127, Italy

Policlinico Sant'Orsola Malpighi

Bologna, 40138, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, 47014, Italy

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, 27100, Italy

Università di Roma 'La Sapienza' - Ospedale Umberto 1°

Roma, 00161, Italy

A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette

Turin, 10126, Italy

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Ogaki Municipal Hospital

Gifu, 503-8502, Japan

National Hospital Organization Mito Medical Center

Higashiibaraki-gun, 311-3193, Japan

Tokai University Hospital

Isehara, 259-1193, Japan

Shonan Kamakura General Hospital

Kamakura-shi, 247-8533, Japan

National Cancer Center Hospital East

Kashiwa, 277 8577, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, 343-8555, Japan

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Kurume University Hospital

Kurume, 830-0011, Japan

National Hospital Organization Matsumoto Medical Center

Matsumoto, 399-8701, Japan

Nagoya City University Hospital

Nagoya, 467 8602, Japan

Hyogo Medical University Hospital

Nishinomiya Shi, 663 8501, Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

National Hospital Organization Hiroshima-Nishi Medical Center

Ōtake, 739-0696, Japan

Hokkaido University Hospital

Sapporo, 060-8648, Japan

Tohoku University Hospital

Sendai, 980 8574, Japan

National Hospital Organization Sendai Medical Center

Sendai, 983-8520, Japan

Japanese Red Cross Medical Center

Shibuya-ku, 150-8935, Japan

Iwate Medical University Hospital

Shiwa-gun, 028-3695, Japan

VU Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Sint Antonius Ziekenhuis - Afd.Interne - INT

Nieuwegein, 3435 CM, Netherlands

Radboudumc

Nijmegen, 6525GA, Netherlands

Isala Kliniek

Zwolle, 8025 AB, Netherlands

Klinika Hematologii i Transplantologii, UCK

Gdansk, 80-214, Poland

Pratia Onkologia Katowice

Katowice, 40 519, Poland

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, 25 734, Poland

Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli

Lublin, 20 090, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, 02-781, Poland

Specjalistyczny Szpital im dra Alfreda Sokolowskiego w Walbrzychu

Wałbrzych, 58 309, Poland

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, 50 367, Poland

S.P. Botkin Moscow City Clinical Hospital 1

Moscow, 125284, Russia

S.P. Botkin Moscow City Clinical Hospital

Moscow, 125284, Russia

Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, 191024, Russia

Kyungpook National University Hospital

Daegu, 41944, South Korea

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

Seoul National University Hospital

Seoul, 03080, South Korea

Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

Samsung Medical Center

Seoul, 06351, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, 06591, South Korea

Inst. Cat. Doncologia-H Duran I Reynals

Barcelona, 08908, Spain

Hosp Univ Vall D Hebron

Barcelona, 8035, Spain

Hosp. de Cabuenes

Gijón, 33394, Spain

Hosp. Univ. de Gran Canaria Dr. Negrin

Las Palmas de Gran Canaria, 35010, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, 28007, Spain

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Hosp. Univ. Son Espases

Palma, 7120, Spain

Clinica Univ. de Navarra

Pamplona, 31008, Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223, Spain

Hosp Clinico Univ de Salamanca

Salamanca, 37007, Spain

Hosp. Univ. Marques de Valdecilla

Santander, 39008, Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Falu Lasarett

Falun, 791 82, Sweden

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Helsingborgs lasarett

Helsingborg, 25187, Sweden

Sunderby Sjukhus

Luleå, 971 80, Sweden

Skanes universitetssjukhus

Lund, 221 85, Sweden

Norrlands Universitetssjukhus

Umeå, 901 85, Sweden

Akademiska Sjukhuset

Uppsala, 75185, Sweden

China Medical University Hospital

Taichung, 40447, Taiwan

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Ankara University Medical Faculty

Ankara, 06590, Turkey (Türkiye)

Ondokuz Mayis University

Atakum, 55280, Turkey (Türkiye)

Medipol University Hospital

Istanbul, 34214, Turkey (Türkiye)

Dokuz Eylul University Medical Faculty

Izmir, 35340, Turkey (Türkiye)

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, FY3 8NR, United Kingdom

Ninewells Hospital & Medical School

Dundee, DD1 9SY, United Kingdom

Kings College Hospital

London, SE5 9RS, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom

University Hospitals Plymouth NHS Trust

Plymouth, PL6 8DH, United Kingdom

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom