Multiple Myeloma Clinical Trial

A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

Summary

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab in combination with pomalidomide and dexamethasone (DPd).

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Full Description

Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy, safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology Group [ECOG] performance status, clinical laboratory tests, vital signs, and AE monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Total duration of study will be up to 6 years 6 months.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio
Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment
Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed
Documented evidence of progressive disease based on investigator's determination of response by the 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 immediately prior to the start of administration of study treatment

Exclusion Criteria:

Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients
Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)
Received prior pomalidomide therapy
A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug
Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

810

Study ID:

NCT05455320

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 210 Locations for this study

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The University of Arizona Cancer Center
Tucson Arizona, 85719, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Norwalk Hospital-oncology
Norwalk Connecticut, 06850, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
George Washington University
Washington District of Columbia, 20037, United States
Memorial Healthcare System
Hollywood Florida, 33021, United States
University of Miami Health System
Miami Florida, 33136, United States
University Of Illinois
Chicago Illinois, 60612, United States
University of Kansas
Westwood Kansas, 66205, United States
Tulane University Hospital & Clinics
New Orleans Louisiana, 70112, United States
Ochsner Health System
New Orleans Louisiana, 70121, United States
Johns Hopkins University
Baltimore Maryland, 21205, United States
Massachusetts General
Boston Massachusetts, 02114, United States
Boston University Medical Center
Boston Massachusetts, 02118, United States
University of Massachusetts Medical School
Worcester Massachusetts, 01655, United States
University of Michigan Health System
Ann Arbor Michigan, 48109, United States
University Of Minnesota
Minneapolis Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
NYU Langone Health
New York New York, 10016, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
University of North Carolina
Chapel Hill North Carolina, 27599, United States
Levine Cancer Institute, Carolinas HealthCare System
Charlotte North Carolina, 28204, United States
Novant Health
Charlotte North Carolina, 28204, United States
Novant Health
Winston-Salem North Carolina, 27103, United States
Wake Forest Baptist Medical Center
Winston-Salem North Carolina, 27157, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus Ohio, 43210, United States
OhioHealth
Columbus Ohio, 43214, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Baptist Cancer Center
Memphis Tennessee, 38120, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Joe Arrington Cancer Research Treatment Center
Lubbock Texas, 79410, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
University of Virginia
Charlottesville Virginia, 22903, United States
Virginia Commonwealth University - Massey Cancer Center
Richmond Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
UZ Brussel
Brussel , 1090, Belgium
UZA
Edegem , 2650, Belgium
Virga Jessa Ziekenhuis
Hasselt , 3500, Belgium
CHC MontLegia
Liège , 4000, Belgium
Clinique Saint Pierre
Ottignies , 1340, Belgium
UCL Mont Godinne
Yvoir , 5530, Belgium
Fundacao Pio XII
Barretos , 14784, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte , 30150, Brazil
Hospitais Integradaos da Gavea S/A - DF Star
Brasilia , 70390, Brazil
Fundacao Universidade de Caxias do Sul
Caxias do Sul , 95070, 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
Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP
Ribeirão Preto , 14051, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22775, Brazil
Hospital Sao Rafael
Salvador , 41253, Brazil
Hospital Paulistano
Sao Paulo , 01323, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Sao Paulo , 01401, Brazil
Fundacao Antonio Prudente - A.C. Camargo Cancer Center
Sao Paulo , 01509, Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo , 01308, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo , 01321, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Peking Union Medical College Hospital
Beijing , 10000, China
Beijing Chaoyang Hospital
Beijing , 10002, China
Peking University First Hospital
Beijing , 10003, China
The First Hospital of Jilin University
Changchun , 13002, China
The second Xiangya Hospital of Central South University
ChangSha , 41000, China
Sichuan Academy of Medical Science Sichuan Provincial People's Hospital
Chengdu , 61007, China
Fujian Medical University Union Hospital
Fuzhou , 35000, China
Sun Yat-Sen University Cancer Center
Guangzhou , 51006, China
Guangdong Provincial People's Hospital
Guangzhou , 51008, China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou , 31000, China
Nanjing Drum Tower Hospital
Nanjing , 21000, China
Tongji Hospital of Tongji University
Shanghai , 20006, China
Shanghai Fourth People's Hospital
Shanghai , 20043, China
Peking University Shenzhen Hospital
Shenzhen , 51803, China
First Affiliated Hospital, SooChow University
Su Zhou , 21500, China
Tianjin cancer hospital
Tianjin , 30006, China
Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science
Tianjin , 30032, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan , 43003, 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 - Poruba , 708 5, Czechia
Fakultni nemocnice Kralovske Vinohrady
Praha 10 , 100 3, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie
Praha 2 , 128 0, Czechia
APHP - Hopital Henri Mondor
Creteil , 94010, France
CHU Dijon
Dijon , 21000, France
Centre Leon Berard
Lyon , 69008, France
CHU de Montpellier - Hopital Saint-Eloi
Montpellier Cedex 5 , 34295, France
CHU de Nantes hotel-Dieu
Nantes , 44093, France
CHU HOPITAL DE L'ARCHET - Hematology
Nice N/a , 06202, France
CHU Hopital Saint Antoine
Paris Cedex 12 , 75571, France
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
Pessac , 33604, France
Institut Universitaire du cancer de Toulouse-Oncopole
TOULOUSE Cedex 9 , 31059, France
Charite Campus Benjamin Franklin
Berlin , 12203, Germany
Asklepios Klinik Altona
Hamburg , 22763, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitaetsklinikum Koelnt
Koeln , 50937, Germany
Universitaetsklinikum Leipzig
Leipzig , 04103, Germany
Universitätsmedizin der Johannes Gutenberg Universität
Mainz , 55131, Germany
Universitaetsklinikum Wuerzburg
Wuerzburg , 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
Ha'Emek Medical Center
Afula , 18341, Israel
Shamir Medical Center (Assaf Harofeh)
Be'er Ya'akov , 70300, Israel
Bnai Zion Medical Center
Haifa , 31048, Israel
Rambam Medical Center
Haifa , 31096, Israel
Carmel Medical Center
Haifa , 34362, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Galilee Medical Center
Nahariya , 22100, Israel
Beilinson medical center
Petah Tikva , 49100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Ziv Medical Center
Safed , 13100, Israel
Sourasky (Ichilov) Medical Center
Tel Aviv , 64239, Israel
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona , 60126, Italy
Policlinico di Bari
Bari , 70124, Italy
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia , 25123, Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania , 95123, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milano , 20162, Italy
Azienda Ospedaliera Universitaria di Padova
Padova , 35128, Italy
Ospedale Villa Sofia-Cervello
Palermo , 90146, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia , 42123, Italy
Presidio Ospedaliero Santo Spirito in Sassia
Roma , 00193, Italy
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo , 71013, Italy
A.O.U. Città della Salute e della Scienza
Torino , 10126, Italy
Tokyo Medical and Dental University Hospital
Bunkyo-Ku , 113-8, Japan
Chiba Cancer Center
Chiba , 260-8, Japan
Fukuoka University Hospital
Fukuoka , 814-0, Japan
Ogaki Municipal Hospital
Gifu , 503-8, Japan
Gunma University Hospital
Gunma , 371-0, Japan
Kansai Medical University Hospital
Hirakata , 573-1, Japan
Japanese Red Cross Society Himeji Hospital
Hyogo , 670-8, Japan
Hyogo Medical University Hospital
Hyôgo , 663-8, 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
Kyoto Kuramaguchi Medical Center
Kyoto , 603-8, Japan
National Hospital Organization Matsumoto Medical Center
Matsumoto , 399-8, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Hiroshima West Medical Center
Otake , 739-0, Japan
Hokkaido University Hospital
Sapporo-shi , 060-8, Japan
Tohoku University Hospital
Sendai , 980-8, Japan
Iwate Medical University Hospital
Shiwa-gun , 028-3, Japan
Osaka University Hospital
Suita-shi , 565-0, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Dong-A University Hospital
Busan , 602-8, Korea, Republic of
National Cancer Center
Gyeonggi-do , 10408, Korea, Republic of
Gachon University Gil Medical Center
Incheon , 21565, Korea, Republic of
Chonnam National University Hwasun Hospital
Jeollanam-do , 58128, Korea, Republic of
Jeonbuk National University Hospital
Jeonju-si , 54907, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, 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
Albert Schweitzer ziekenhuis-lokatie Dordwijk
Dordrecht , 3318 , Netherlands
Maxima Medisch Centrum
Eindhoven , 5631 , Netherlands
Erasmus MC
Rotterdam , 3015 , Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
Brzozow , 36-20, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
Kielce , 25-73, Poland
Szpital Uniwersytecki w Krakowie
Krakow , 30 68, Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli
Lublin , 20090, Poland
Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii
Olsztyn , 10-22, Poland
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun , 87-10, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warszawa , 02-78, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw , 52-00, Poland
Hosp. Univ. Germans Trias I Pujol
Badalona , 08916, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona , 08025, Spain
Hosp. Univ. Vall D Hebron
Barcelona , 08035, Spain
Hosp. Clinic de Barcelona
Barcelona , 08036, Spain
Hosp. Univ. Virgen de La Arrixaca
El Palmar, Murcia , 30120, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera , 11407, Spain
Hosp. de Leon
Leon , 24071, Spain
Hosp. Univ. de La Princesa
Madrid , 28006, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. Hm Sanchinarro
Madrid , 28050, Spain
Hosp. Virgen de La Victoria
Malaga , 29010, Spain
Clinica Univ. de Navarra
Pamplona , 31008, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Hosp. Univ. de Canarias
San Cristóbal de La Laguna , 38320, Spain
Hosp. Univ. Dr. Peset
Valencia , 46017, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , 80756, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung , 83301, Taiwan
China Medical University Hospital
Taichung City , 40447, Taiwan
National Cheng Kung University Hospital
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 10048, Taiwan
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit
Ankara , 06200, Turkey
Ankara University Medical Faculty
Ankara , 06590, Turkey
Liv Hospital Ankara
Ankara , 06680, Turkey
Antalya Training And Research Hospital
Antalya , 07100, Turkey
Medipol Mega University Hospital
Istabul , 34214, Turkey
Istanbul University Istanbul Medical Faculty
Istanbul , 34093, Turkey
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34153, Turkey
Dokuz Eylul University Medical Faculty
Izmir , 35330, Turkey
On Dokuz Mayıs University Medical Faculty
Samsun , 55139, Turkey
Blackpool Victoria Hospital
Blackpool , FY3 8, United Kingdom
Ninewells Hospital & Medical School
Dundee , DD1 9, United Kingdom
Imperial College Healthcare
London , W2 1N, United Kingdom
Newcastle Freeman Hospital
Newcastle Upon Tyne , NE7 7, United Kingdom
Nottingham City Hospital
Nottingham , NG5 1, United Kingdom
University Hospitals Plymouth NHS Trust
Plymouth , PL6 8, United Kingdom
Royal Marsden Hospital
Sutton , SM2 5, 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:

810

Study ID:

NCT05455320

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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