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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05083169
Other study ID # CR109049
Secondary ID 2020-004742-1164
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date October 14, 2021
Est. completion date December 8, 2028

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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). 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 587
Est. completion date December 8, 2028
Est. primary completion date August 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: 1. 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, 2. 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Daratumumab
Daratumumab will be administered SC injection.
Pomalidomide
Pomalidomide will be administered orally.
Dexamethasone
Dexamethasone will be administered orally or intravenously.
Bortezomib
Bortezomib will be administered SC injection.
Teclistamab
Teclistamab will be administered SC injection.

Locations

Country Name City State
Argentina Hospital Aleman Buenos Aires
Argentina Hospital Italiano de Buenos Aires Buenos Aires
Argentina Hospital Privado - Centro Medico de Cordoba Cordoba
Belgium ZNA Cadix Antwerpen
Belgium AZ St.-Jan Brugge-Oostende AV Brugge
Belgium UZ Gent Gent
Belgium Hopital de Jolimont Haine Saint Paul La Louviere
Belgium Az Groeninge Kortrijk
Belgium UZ Leuven Leuven
Belgium Algemeen Ziekenhuis Delta Roeselare
Brazil Hospitais Integradaos da Gavea S/A - DF Star Brasilia
Brazil Liga Paranaense de Combate ao Cancer Curitiba
Brazil Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN Florianopolis
Brazil Liga Norte Riograndense Contra O Cancer Natal
Brazil Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre
Brazil Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) Rio de Janeiro
Brazil Hospital Sao Rafael Salvador
Brazil Clinica Sao Germano Sao Paulo
Brazil Hospital Paulistano Sao Paulo
Brazil Real e Benemerita Associacao Portuguesa de Beneficencia Sao Paulo
Brazil Instituto D Or de Pesquisa e Ensino (IDOR) São Paulo
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada QEII Health Sciences Halifax Nova Scotia
Canada Princess Margaret Cancer Centre University Health Network Toronto Ontario
Canada BC Cancer Agency - Vancouver BC Vancouver British Columbia
China Peking University First Hospital Beijing
China Peking University People s Hospital Beijing
China Peking University Third Hospital Beijing
China The First Hospital of Jilin University Changchun
China The Third Xiangya Hospital of Central Sourth University Changshashi
China Beijing Chaoyang Hospital Chaoyang District
China West China Hospital Sichuan University Chengdu
China Fujian Meidical University Union Hospital Fuzhou
China Sun Yat-Sen University Cancer Center Guangzhou
China First affiliated Hospital of Zhejiang University Hangzhou
China Zhongda Hospital Southeast University Nanjing
China First Affiliated Hospital of Guangxi Medical University Nanning
China Shanghai Zhongshan Hospital Shanghai
China Shengjing Hospital Of China Medical University Shenyang
China Peking University Shenzhen Hospital Shenzhen
China Tianjin Medical University Cancer Institute and Hospital Tianjin
China Tianjin Medical University General Hospital Tianjin
China The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an
China The Affiliated Hospital of Xuzhou Medical University Xuzhou
China Henan Cancer Hospital Zhengzhou
Denmark Aalborg University Hospital Aalborg
Denmark Aarhus University Hospital Aarhus N
Denmark Rigshospitalet Copenhagen
Denmark Odense Universitets Hospital Odense
Denmark Vejle Hospital Vejle
France CHU Henri Mondor Creteil
France CHRU de Lille Hopital Claude Huriez LILLE Cedex
France CHU de Limoges Hopital Dupuytren Limoges
France C.H.U. Hotel Dieu - France Nantes
France Centre hospitalier Lyon-Sud Pierre Benite cedex
France CHU De Poitiers Poitiers
France Institut de Cancerologie Strasbourg Europe ICANS Strasbourg
France Pôle IUC Oncopole CHU Toulouse cedex 9
France CHRU Hôpital Bretonneau Tours
Germany Universitätsklinikum Carl-Gustav-Carus Dresden Dresden
Germany Heinrich-Heine -Universitaet Duesseldorf Düsseldorf
Germany Evang. Krankenhaus Essen-Mitte gGmbH Essen
Germany Universitatsklinikum Freiburg Freiburg
Germany Universitaetsklinikum Hamburg Eppendorf Hamburg
Germany St. Barbara-Klinik Hamm GmbH Hamm
Germany Universitaetsklinikum Heidelberg Heidelberg
Germany Universitaetsklinikum Schleswig-Holstein Campus Kiel Kiel
Germany Universitaetsklinikum Leipzig Leipzig
Germany Universitaetsklinikum Tuebingen Tubingen
Greece Alexandra General Hospital of Athens Athens Attica
Greece Anticancer Hospital of Thessaloniki Theageneio Thessaloniki
Greece G.Papanikolaou Thessaloniki
Italy U.O. Ematologia con Trapianto- AOU Policlinico di Bari Bari
Italy ASST Papa Giovanni XXIII - Bergamo Bergamo
Italy Policlinico Sant'Orsola Malpighi Bologna
Italy Azienda Ospedaliera Universitaria Careggi Firenze
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola
Italy IRCCS Policlinico San Matteo, Università degli studi di Pavi Pavia
Italy Università di Roma 'La Sapienza' - Ospedale Umberto 1° Roma
Italy A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette Turin
Japan Fukuoka University Hospital Fukuoka
Japan Ogaki Municipal Hospital Gifu
Japan National Hospital Organization Mito Medical Center Higashiibaraki-gun
Japan Tokai University Hospital Isehara
Japan Shonan Kamakura General Hospital Kamakura-shi
Japan National Cancer Center Hospital East Kashiwa
Japan Dokkyo Medical University Saitama Medical Center Koshigaya
Japan Kumamoto University Hospital Kumamoto
Japan Kurume University Hospital Kurume
Japan National Hospital Organization Matsumoto Medical Center Matsumoto
Japan Nagoya City University Hospital Nagoya
Japan Hyogo Medical University Hospital Nishinomiya-shi
Japan National Hospital Organization Okayama Medical Center Okayama
Japan National Hospital Organization Hiroshima-Nishi Medical Center Otake
Japan Hokkaido University Hospital Sapporo-shi
Japan Tohoku University Hospital Sendai
Japan National Hospital Organization Sendai Medical Center Sendai-City
Japan Japanese Red Cross Medical Center Shibuya-ku
Japan Iwate Medical University Hospital Shiwa-gun
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Gachon University Gil Medical Center Incheon
Korea, Republic of Chonnam National University Hwasun Hospital Jeollanam-do
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary's Hospital Seoul
Netherlands VU Medisch Centrum Amsterdam
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Sint Antonius Ziekenhuis - Afd.Interne - INT Nieuwegein
Netherlands Radboudumc Nijmegen
Netherlands Isala Kliniek Zwolle
Poland Klinika Hematologii i Transplantologii, UCK Gdansk
Poland Pratia Onkologia Katowice Katowice
Poland Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce
Poland Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli Lublin
Poland Specjalistyczny Szpital im. dra Alfreda Sokolowskiego w Walbrzychu Walbrzych
Poland Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw
Russian Federation S.P. Botkin Moscow City Clinical Hospital Moscow
Russian Federation Clinical Research Institute of Hematology and Transfusiology St-Petersburg
Spain Hosp. Univ. Vall D Hebron Barcelona
Spain Inst. Cat. Doncologia-H Duran I Reynals Barcelona
Spain Hosp. de Cabuenes Gijón
Spain Hosp. Univ. de Gran Canaria Dr. Negrin Las Palmas de Gran Canaria
Spain Hosp. Gral. Univ. Gregorio Maranon Madrid
Spain Hosp. Univ. 12 de Octubre Madrid
Spain Hosp. Univ. Ramon Y Cajal Madrid
Spain Hosp. Univ. Son Espases Palma
Spain Clinica Univ. de Navarra Pamplona
Spain Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcon
Spain Hosp Clinico Univ de Salamanca Salamanca
Spain Hosp. Univ. Marques de Valdecilla Santander
Spain Hosp. Clinico Univ. de Santiago Santiago de Compostela
Spain Hosp. Virgen Del Rocio Sevilla
Spain Hosp. Univ. I Politecni La Fe Valencia
Sweden Falu Lasarett Falun
Sweden Sahlgrenska University Hospital Göteborg
Sweden Helsingborgs lasarett Helsingborg
Sweden Sunderby Sjukhus Luleå
Sweden Skanes universitetssjukhus Lund
Sweden Norrlands Universitetssjukhus Umea
Sweden Akademiska Sjukhuset Uppsala
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Chang Gung Memorial Hospital Taoyuan
Turkey Ankara University Medical Faculty Ankara
Turkey Ondokuz Mayis University Atakum
Turkey Medipol University Hospital Istanbul
Turkey Dokuz Eylul University Medical Faculty Izmir
United Kingdom Blackpool Teaching Hospitals NHS Foundation Trust Blackpool
United Kingdom Ninewells Hospital & Medical School Dundee
United Kingdom Kings College Hospital London
United Kingdom Oxford University Hospitals NHS Foundation Trust Oxford
United Kingdom University Hospitals Plymouth NHS Trust Plymouth
United Kingdom Royal Marsden Hospital Sutton
United States Emory University - Winship Cancer Institute Atlanta Georgia
United States University of Alabama Birmingham Birmingham Alabama
United States Tufts Medical Center Boston Massachusetts
United States Medical University of South Carolina Charleston South Carolina
United States Cleveland Clinic Cleveland Ohio
United States University of Texas Southwestern Medical Center Dallas Texas
United States Henry Ford Hospital Detroit Michigan
United States City of Hope Duarte California
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin
United States Baptist Cancer Center Memphis Tennessee
United States Vanderbilt - Ingram Cancer Center Nashville Tennessee
United States Yale University New Haven Connecticut
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States Huntsman Cancer Institute Salt Lake City Utah
United States Seattle Cancer Care Alliance Seattle Washington
United States Ascension Providence Hospital Southfield Michigan
United States Stanford University Medical Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  China,  Denmark,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. Up to 5 years
Secondary Overall Response (Partial Response [PR] or Better) Overall response (PR or better) is defined as participants who have a PR or better per IMWG criteria. Up to 5 years
Secondary Very Good Partial Response (VGPR) or Better VGPR or better is defined as participants who achieve a VGPR or better response per IMWG criteria. Up to 5 years
Secondary Complete Response (CR) or Better CR or better is defined as participants who achieve a CR or better response per IMWG criteria. Up to 5 years
Secondary Minimal Residual Disease (MRD)-negativity MRD-negativity is defined as participants who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the date of randomization and before disease progression or start of subsequent antimyeloma therapy. Up to 5 years
Secondary Progression Free Survival on Next-line Therapy (PFS2) PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first. Up to 5 years
Secondary Overall Survival (OS) OS is measured from the date of randomization to the date of the participant's death. Up to 5 years
Secondary Time to Next Treatment (TTNT) TTNT is defined as the interval time from randomization to the start of subsequent antimyeloma treatment. Up to 5 years
Secondary Duration of Response Duration of response will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria, or death due to any cause, whichever occurs first. Up to 5 years
Secondary Number of Participants with Adverse Events (AEs) by Severity Number of participants with AEs by Severity will be reported. Up to 5 years
Secondary Serum Concentration of Teclistamab Serum samples will be analyzed to determine concentrations of teclistamab using a validated, specific, and sensitive method. Up to 5 years
Secondary Number of Participants with Anti-drug Antibodies (ADAs) to Teclistamab and Daratumumab Number of participants with ADAs to teclistamab and daratumumab will be reported. Up to 5 years
Secondary Time to Worsening of Symptoms Time to worsening is measured as the interval from the date of randomization to the start date of meaningful change. Up to 5 years
Secondary Change from Baseline in Symptoms, Functioning, and Overall 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) The EORTC-QLQ-C30 Version 3 includes 30 items in 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high HRQoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. Baseline up to 5 years
Secondary Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items resulting in a symptom subscale and an impact subscale. The recall period is the "past 7 days", and responses are reported on a 5-point verbal rating scale. Baseline up to 5 years
Secondary Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF 8c) The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. Higher overall score indicates more sleep disturbance. Baseline up to 5 years
Secondary Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE ) The National Cancer Institute's (NCI's) PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting of treatment tolerability. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference of the AEs. It ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact. Baseline up to 6 months
Secondary Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L) The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline up to 5 years
Secondary Change from Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Patient Global Impression - Severity (PGI-S) The PGIS contains 2 questions on how the participant would currently rate severity of symptoms and impacts with a 7-day recall period. The response options are presented as a 5-point verbal rating scale from 1="none" to 5="very severe." Baseline up to 5 years
Secondary PFS in Participants with High-risk Molecular Features PFS in participants with high-risk molecular features will be reported. Up to 5 years
Secondary Depth of Response in Participants in High-risk Molecular Features Depth of response in participants in high-risk molecular features will be reported. Up to 5 years
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