Multiple Myeloma Clinical Trial

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

Summary

The purpose of this study is to compare the efficacy of teclistamab-daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd) in Part 1 and to evaluate the pharmacokinetics (PK), safety, and efficacy of the Tec-Dara regimen when teclistamab is administered using a alternative dosing schedule in Part 2.

View Full Description

Full Description

Teclistamab is a novel B-cell maturation antigen (BCMA) bispecific antibody that is being evaluated to treat participants with multiple myeloma, an incurable malignant plasma cell disorder. The primary hypothesis of this study is that Tec-Dara will significantly improve progression free survival (PFS) compared with investigator's choice of DPd/DVd in participants with relapsed refractory multiple myeloma. Approximately 560 participants will be randomly assigned in a 1:1 ratio to receive either Tec-Dara (Arm A) or investigator's choice of DPd/DVd (Arm B) in Part 1 and approximately 70 participants will be enrolled in Part 2. The study will be conducted in 3 phases: Screening Phase, Treatment Phase, and Follow-up Phase. Participants will be treated until disease progression, unacceptable toxicity, or other reasons to discontinue the study. Disease evaluation will occur every cycle. Safety will be assessed throughout the study. Efficacy will be assessed using International Myeloma Working Group (IMWG) criteria. The overall duration of the study will be approximately 5 years.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

630

Study ID:

NCT05083169

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 198 Locations for this study

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University of Alabama Birmingham
Birmingham Alabama, 35294, United States
City of Hope
Duarte California, 91010, United States
Stanford University Medical Center
Stanford California, 94305, 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
Ascension Providence Hospital
Southfield Michigan, 48075, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Oregon Health & Science University
Portland Oregon, 97239, 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, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States
Vanderbilt - Ingram Cancer Center
Nashville Tennessee, 37212, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75235, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
Medical College Of Wisconsin
Milwaukee Wisconsin, 53226, United States
Fundaleu
Buenos Aires , C1114, Argentina
Hospital Aleman
Buenos Aires , C1118, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires , C1199, Argentina
Hospital Privado - Centro Medico de Cordoba
Cordoba , X5016, Argentina
ZNA Stuivenberg
Antwerpen , 2060, Belgium
AZ St.-Jan Brugge-Oostende AV
Brugge , 8000, Belgium
UZ Gent
Gent , 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
Brasilia , 70390, Brazil
Liga Paranaense de Combate ao Cancer
Curitiba , 81520, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Florianopolis , 88034, Brazil
Liga Norte Riograndense Contra O Cancer
Natal , 59062, Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre , 90050, Brazil
Oncoclínicas Rio de Janeiro S.A.
Rio de Janeiro , 22250, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22793, Brazil
Hospital Sao Rafael
Salvador , 41253, Brazil
Hospital Paulistano
São Paulo , 01321, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo , 01323, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo , 45010, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
BC Cancer Agency - Vancouver BC
Vancouver British Columbia, V5Z 4, Canada
QEII Health Sciences
Halifax Nova Scotia, B3H 2, Canada
Princess Margaret Cancer Centre University Health Network
Toronto Ontario, M5G 1, Canada
McGill University Health Centre
Montreal Quebec, H4A 3, Canada
CHU de Québec
Quebec , G1R 2, Canada
Beijing Chaoyang Hospital
Beijing , 10002, China
Peking University First Hospital
Beijing , 10003, China
Peking University People's Hospital
Beijing , 10004, China
Peking University Third Hospital
Beijing , 10019, China
The First Hospital of Jilin University
Changchun , 13002, China
The Third Xiangya Hospital of Central Sourth University
Changshashi , 41001, China
West China Hospital, Sichuan University
Chengdu , 61004, China
The Second Hospital To Dalian Medical University
Dalian , 11601, China
Fujian Meidical University Union Hospital
Fuzhou , 35000, China
Sun Yat-Sen University Cancer Center
Guangzhou , 51006, China
First affiliated Hospital of Zhejiang University
Hangzhou , 31000, China
Zhongda Hospital,Southeast University
Nanjing , 21000, China
First Affiliated Hospital of Guangxi Medical University
Nanning , 53002, China
Shanghai Changzheng Hospital
Shanghai , 20000, China
Shanghai Zhongshan Hospital
Shanghai , 20003, China
Shengjing Hospital of China Medical University
Shenyang , 11002, China
Peking University Shenzhen Hospital
Shenzhen , 51803, China
Tianjin Medical University General Hospital
Tianjin , 30001, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China
Wuhan Union Hospital
Wuhan , 43002, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an , 71000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou , 22100, China
Henan Cancer Hospital
Zhengzhou , 45000, China
Aalborg University Hospital
Aalborg , DK-90, Denmark
Aarhus University Hospital
Aarhus N , DK-82, Denmark
Rigshospitalet
Copenhagen , 2100, Denmark
Odense Universitets Hospital
Odense , 5000, Denmark
Vejle Hospital
Vejle , DK-71, Denmark
CHU Henri Mondor
Creteil , 94000, France
CHRU de Lille - Hôpital Claude Huriez
LILLE Cedex , 59037, France
CHU de Limoges, Hopital Dupuytren
Limoges , 87042, France
C.H.U. Hotel Dieu - France
Nantes , 44093, France
Centre hospitalier Lyon-Sud
Pierre Benite cedex , 69495, France
CHU De Poitiers
Poitiers , 86021, France
Institut de Cancérologie Strasbourg Europe (ICANS)
Strasbourg , 67200, France
Pôle IUC Oncopole CHU
Toulouse cedex 9 , 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 , 79106, Germany
Universitaetsklinikum Hamburg Eppendorf
Hamburg , 20246, Germany
St Josef Krankenhaus
Hamm , 59075, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel , 24105, Germany
Universitatsklinikum Leipzig
Leipzig , 04103, Germany
Universitaetsklinikum Tuebingen
Tübingen , 72076, Germany
Alexandra General Hospital of Athens
Athens Attica , 115 2, Greece
University of Athens - Evaggelismos Hospital (Evangelismos Hospital)
Athens , 106 7, Greece
Anticancer Hospital of Thessaloniki 'Theageneio'
Thessaloniki , 546 3, 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
Firenze , 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 , 814-0, Japan
Ogaki Municipal Hospital
Gifu , 503-8, Japan
National Hospital Organization Mito Medical Center
Higashiibaraki-gun , 311-3, Japan
The Hospital of Hyogo College of Medicine
Hyôgo , 663-8, Japan
Tokai University Hospital
Isehara , 259-1, Japan
Shonan Kamakura General Hospital
Kamakura-shi , 247-8, Japan
National Cancer Center Hospital East
Kashiwa , 277-8, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya , 343-8, Japan
Kumamoto University Hospital
Kumamoto , 860-8, Japan
Kurume University Hospital
Kurume , 830-0, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto , 399-8, Japan
Nagoya City University Hospital
Nagoya , 467-8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
National Hospital Organization Hiroshima-Nishi Medical Center
Otake , 739-0, Japan
Hokkaido University Hospital
Sapporo-shi , 060-8, Japan
National Hospital Organization Sendai Medical Center
Sendai-City , 983-8, Japan
Tohoku University Hospital
Sendai , 980-8, Japan
Japanese Red Cross Medical Center
Shibuya-ku , 150-8, Japan
Iwate Medical University Hospital
Shiwa-gun , 028-3, Japan
Kyungpook National University Hospital
Daegu , 41944, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
VU Medisch Centrum
Amsterdam , 1081 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9713 , Netherlands
Sint Antonius Ziekenhuis - Afd.Interne - INT
Nieuwegein , 3435 , Netherlands
Radboudumc
Nijmegen , 6525G, Netherlands
Isala Kliniek
Zwolle , 8025 , Netherlands
Klinika Hematologii i Transplantologii, UCK
Gdansk , 80-95, Poland
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce , 25-73, Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin , 20-09, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Specjalistyczny Szpital im. dra Alfreda Sokołowskiego w Wałbrzychu
Wałbrzych , 58-30, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw , 50-36, Poland
S.P. Botkin Moscow City Clinical Hospital
Moscow , 12528, Russian Federation
S.P. Botkin Moscow City Clinical Hospital
Moscow , 12528, Russian Federation
Saint-Petersburg State Pavlov University
Saint-Petersburg , 19702, Russian Federation
Samara State Medical Univeristy
Samara , 44307, Russian Federation
Samara Region Clinical Hospital
Samara , 44309, Russian Federation
Federal Center of Heart, Blood and Endocrinology
Sankt-Peterburg , 19734, Russian Federation
Clinical Research Institute of Hematology and Transfusiology
St-Petersburg , 19102, Russian Federation
St.-Petersburg City Clinical Hospital nr 31
St. Petersburg , 19711, Russian Federation
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 Marañon
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 Alarcon , 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
Sevilla , 41013, Spain
Hosp. Univ. I Politecni La Fe
Valencia , 46026, Spain
Falu Lasarett
Falun , 791 8, Sweden
Sahlgrenska University Hospital
Göteborg , 413 4, Sweden
Helsingborgs lasarett
Helsingborg , 25187, Sweden
Sunderby Sjukhus
Luleå , 971 8, Sweden
Skanes universitetssjukhus
Lund , 221 8, Sweden
Universitetssjukhuset Orebro
Orebro , 703 6, Sweden
Karolinska Universitetssjukhuset, Huddinge
Stockholm , 141 8, Sweden
Norrlands Universitetssjukhus
Umea , 901 8, 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
Ondokuz Mayis University
Atakum , 55280, Turkey
Istanbul University Istanbul Medical Faculty
Istanbul , 34093, Turkey
Medipol University Hospital
Istanbul , 34214, Turkey
Dokuz Eylul University Medical Faculty
Izmir , 35340, Turkey
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool , FY3 8, United Kingdom
Ninewells Hospital & Medical School
Dundee , DD1 9, United Kingdom
St James University Hospital
Leeds , LS9 7, United Kingdom
Leicester Royal Infirmary Haematology
Leicester , LE1 5, United Kingdom
University College Hospital
London , NW1 2, United Kingdom
Kings College Hospital
London , SE5 9, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , NG5 1, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford , OX3 7, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth , PL6 8, United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

630

Study ID:

NCT05083169

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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