Clinical trial NCT05552222: A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Official title: A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 1590
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).


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 participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment

Exclusion Criteria:

* Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 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 or talquetamab excipients
* Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
* Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From randomization to the date of disease progression or death (Up to 09 years)
measure: 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)
timeFrame: At Month 12
Secondary outcomes:
measure: Very Good Partial Response (VGPR) or Better
timeFrame: From randomization up to 09 years
measure: Complete Response (CR) or Better
timeFrame: From randomization up to 09 years
measure: Sustained Minimal Residual disease (MRD)-negative Complete Response (CR)
timeFrame: From randomization up to 09 years
measure: MRD-negative CR
timeFrame: From randomization up to 09 years
measure: Progression Free Survival on Next-line Therapy (PFS2)
timeFrame: From randomization up to 09 years
measure: Overall Survival (OS)
timeFrame: From randomization to the date of death (up to 09 years)
measure: Number of Participants with Adverse Events (AEs) by Severity
timeFrame: From randomization up to 09 years
measure: Number of Participants with Abnormalities in Laboratory Parameters
timeFrame: From randomization up to 09 years
measure: Number of Participants with Abnormalities in Vital Signs
timeFrame: From randomization up to 09 years
measure: Number of Participants with Abnormalities in Physical Examination
timeFrame: From randomization up to 09 years
measure: Number of Participants with Abnormalities in Electrocardiogram (ECG)
timeFrame: From randomization up to 09 years
measure: Serum Concentrations of Teclistamab and Talquetamab
timeFrame: From randomization up to 09 years
measure: Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Talquetamab
timeFrame: From randomization up to 09 years
measure: Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)
timeFrame: From baseline up to 9 years
measure: Change from Baseline in Treatment-related Symptoms as Assessed by Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Baseline through Cycle 6 (each cycle of 28 days) (up to 196 days)
measure: Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)
timeFrame: From baseline up to 9 years
measure: Time to Sustained Worsening in Symptoms, Functioning, and HRQoL
timeFrame: From randomization up to 09 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Cancer Center
state: California
city: Irvine
country: United States
facility: City of Hope Orange County Lennar Foundation Cancer Center
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Waukee
country: United States
facility: University of Iowa Health Care
state: Iowa
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Grand Rapids
country: United States
facility: Cancer And Hematology Centers of Western Michigan PC
state: Michigan
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Santa Fe
country: United States
facility: Christus St. Vincent Regional Cancer Center
state: New Mexico
city: Durham
country: United States
facility: Durham VAMC
state: North Carolina
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Geelong
country: Australia
facility: Barwon Health - University Hospital Geelong
city: Liverpool
country: Australia
facility: Liverpool Hospital
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
city: New South Wales
country: Australia
facility: Calvary Mater Newcastle Hospital
city: Wollongong
country: Australia
facility: Wollongong Hospital
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
city: Salzburg
country: Austria
facility: SCRI CCCIT gem GmbH
city: Vienna
country: Austria
facility: Medical University Vienna
city: Wien
country: Austria
facility: Hanusch Krankenhaus
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Antwerpen
country: Belgium
facility: ZAS Cadix
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Haine Saint Paul La Louviere
country: Belgium
facility: Jolimont
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen- Campus St Augustinus
city: Barretos
country: Brazil
facility: Fundacao Pio XII
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte
city: Curitiba
country: Brazil
facility: Liga Paranaense de Combate ao Cancer
city: Fortaleza
country: Brazil
facility: Instituto Do Cancer Do Ceara
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Cancer
city: Niteroi
country: Brazil
facility: Complexo Hospitalar de Niteroi
city: Porto Alegre
country: Brazil
facility: Hospital De Clinicas De Porto Alegre
city: Ribeirao Preto
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
city: Salvador
country: Brazil
facility: Hospital Sao Rafael
city: Sao Paulo
country: Brazil
facility: Hospital Nove de Julho
city: Sao Paulo
country: Brazil
facility: Clinica Medica Sao Germano S/S LTDA
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP
city: Calgary
country: Canada
facility: Arthur J E Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Quebec
country: Canada
facility: CHU de Quebec L Hotel Dieu de Quebec
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Tongren Hospital CMU
city: Chang Zhou
country: China
facility: Changzhou No 2 Peoples Hospital
city: Changchun
country: China
facility: The First Hospital of Jilin University
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South Hospital
city: Chaoyang District
country: China
facility: Beijing Chaoyang Hospital
city: Chengdu
country: China
facility: Sichuan Provincial Peoples Hospital
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Fu Zhou
country: China
facility: Fujian Meidical University Union Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital
city: Guangzhou
country: China
facility: Sun Yat -Sen University Cancer Center
city: Hang Zhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
city: Hangzhou
country: China
facility: No.1 Affiliated Hospital, Medical College of Zhejiang University
city: Harbin
country: China
facility: Harbin medical university cancer hospital
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Nan Jing
country: China
facility: Zhongda Hospital Southeast University
city: Nan Ning Shi
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
city: Nanchang
country: China
facility: The First Affliated Hospital Of Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Fourth People s Hospital
city: Shen Zhen Shi
country: China
facility: Peking University Shenzhen Hospital
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Tian Jin
country: China
facility: Institute of Hematology and Blood Diseases Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: WuHan
country: China
facility: Wuhan Tongji Hospital Tongji Medical College
city: Xi' An
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
city: Xiamen
country: China
facility: The first affiliated hospital of xiamen university
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Brno - Bohunice
country: Czechia
facility: Fakultni nemocnice Brno
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen
city: Praha
country: Czechia
facility: VFN v Praze
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Herning
country: Denmark
facility: Regionshospitalet Godstrup
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Creteil
country: France
facility: APHP - Hopital Henri Mondor
city: Lille
country: France
facility: Hopital Claude Huriez
city: Nantes
country: France
facility: CHU Nantes
city: PARIS cedex 12
country: France
facility: CHU Hopital Saint Antoine
city: Pessac cedex
country: France
facility: CHU de Bordeaux - Hospital Haut-Leveque
city: Pierre-Benite
country: France
facility: CHU Lyon Sud
city: Poitiers
country: France
facility: CHU Poitiers - Hopital la Miletrie
city: Rennes
country: France
facility: CHU de Rennes - Hopital Pontchaillou
city: Strasbourg
country: France
facility: Institut de Cancerologie Strasbourg Europe ICANS
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse Oncopole
city: Berlin
country: Germany
facility: Helios Kliniken Berlin Buch Gmbh
city: Halle (Saale)
country: Germany
facility: Universitaetsklinikum Halle Saale
city: Hamburg
country: Germany
facility: Universitaetsklinik Hamburg-Eppendorf
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg Nord
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,
city: Wurzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Athens Attica
country: Greece
facility: Alexandra General Hospital of Athens
city: Thessalonikis
country: Greece
facility: G Papanikolaou Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Anticancer Hospital of Thessaloniki Theageneio
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petah Tikva
country: Israel
facility: Rabin
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII Bergamo
city: Bologna
country: Italy
facility: A O U Sant Orsola Malpighi
city: Firenze
country: Italy
facility: Careggi University Hospital
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Naples
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo, Università degli studi di Pavi
city: Roma
country: Italy
facility: Universita Degli Studi di Roma Tor Vergata
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Torino
country: Italy
facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
city: Bunkyo Ku
country: Japan
facility: Juntendo University Hospital
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chiba
country: Japan
facility: Kameda Medical Center
city: Higashiibaraki-gun
country: Japan
facility: National Hospital Organization Mito Medical Center
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
city: Hyôgo
country: Japan
facility: Hyogo Medical University Hospital
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital
city: Matsuyama-City
country: Japan
facility: Matsuyama Red Cross Hospital
city: Nagasaki
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
city: Shibukawa
country: Japan
facility: National Hospital Organization Shibukawa Medical Center
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center
city: Sunto Gun
country: Japan
facility: Shizuoka Cancer Center
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Yamanashi
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Goyang si
country: Korea, Republic of
facility: National Cancer Center
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Amsterdam
country: Netherlands
facility: VUMC Amsterdam
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medical Center
city: Oslo
country: Norway
facility: Oslo University Hospital HF Ulleval sykehus
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Biala Podlaska
country: Poland
facility: Wojewodzki Szpital Kliniczny w Bialej Podlaskiej
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Poznaniu
city: Zielona Gora
country: Poland
facility: Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze
city: Braga
country: Portugal
facility: Uls Braga - Hosp. Braga
city: Lisbon
country: Portugal
facility: Champalimaud Foundation Champalimaud Centre
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia
city: Porto
country: Portugal
facility: Uls Hosp Sao Joao
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Granada
country: Spain
facility: Hosp. Univ. Virgen de Las Nieves
city: Jerez de la Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Madrid
country: Spain
facility: Hosp Univ Hm Sanchinarro
city: Palma de Mallorca
country: Spain
facility: Hosp. Univ. Son Espases
city: Pozuelo de Alarcon
country: Spain
facility: Hosp. Quiron Madrid Pozuelo
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Terrassa
country: Spain
facility: Hosp. Mutua Terrassa
city: Valencia
country: Spain
facility: Hosp. Clinico Univ. de Valencia
city: Falun
country: Sweden
facility: Falu Lasarett
city: Lund
country: Sweden
facility: Skanes universitetssjukhus
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Örebro
country: Sweden
facility: Universitetssjukhuset Orebro
city: Bern
country: Switzerland
facility: Inselspital Universitatsspital Bern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St Gallen
city: Ankara
country: Turkey
facility: Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Ankara
country: Turkey
facility: Liv Hospital Ankara
city: Antalya
country: Turkey
facility: Memorial Antalya Hospital
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty
city: Istanbul
country: Turkey
facility: Medipol University Hospital
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol and Weston
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: Imperial College Healthcare
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: