Multiple Myeloma Clinical Trial

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Summary

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd.

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Full Description

Multiple myeloma is an incurable, malignant, plasma cell disorder. Teclistamab (JNJ-64007957) is a full-size, Immunoglobulin G (IgG) 4 proline, alanine, and alanine (PAA) bispecific antibody that targets the cluster of differentiation (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). With its dual binding sites, teclistamab is able to draw CD3 positive T cells in close proximity to BCMA positive cells, resulting in T-cell activation and subsequent lysis of BCMA positive cells. Pomalidomide is a third-generation immunomodulatory imide drug (IMiD) that exerts potent, direct tumoricidal and immune-enhancing effects and Carfilzomib is a second-generation proteasome inhibitor that inhibits proteasome which results in disruption of protein turnover and induces apoptosis. The primary hypothesis of this study is that teclistamab monotherapy (Arm A) will significantly improve progression free survival (PFS) compared with investigator's choice of PVd or Kd (Arm B) in participants with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The study will include a screening phase, treatment phase, and follow-up phase. Safety will be assessed by physical examinations, neurologic examinations, eastern cooperative oncology group (ECOG) performance status, clinical laboratory tests, vital signs, and AE monitoring. The overall duration of the study will be up to 9 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to 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 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level >=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain >=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio
Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line
Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
Must be willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

Received any prior B cell maturation antigen (BCMA)-directed therapy
A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic blood pressure >99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade >=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event [AE] related to carfilzomib)
Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma.
Received a live, attenuated vaccine within 4 weeks before randomization
Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis
Received a maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14 days prior to randomization

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

590

Study ID:

NCT05572515

Recruitment Status:

Not yet recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 172 Locations for this study

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University of Miami/Sylvester Cancer Center
Miami Florida, 33136, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20814, United States
Boston University Medical Center
Boston Massachusetts, 02118, United States
Saint Luke's Hospital - Saint Luke's Cancer Specialists
Chesterfield Missouri, 63017, United States
Cooper Health System MD Anderson Cancer Center at Cooper
Camden New Jersey, 08103, United States
Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center
New York New York, 10032, United States
Durham VAMC
Durham North Carolina, 27705, United States
Baylor Scott & White Clinic - Temple
Temple Texas, 76508, United States
Fort Belvoir Community Hospital
Fort Belvoir Virginia, 22060, United States
Box Hill Hospital
Box Hill , 3128, Australia
St. Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
Fiona Stanley Hospital
Murdoch , 6150, Australia
Sir Charles Gairdner Hospital
Nedlands , 6009, Australia
LKH - Universitätsklinikum der PMU Salzburg
Salzburg , 5020, Austria
Pyhrn-Eisenwurzen Klinikum Steyr
Steyr , 4400, Austria
Medical University Vienna, MUV
Vienna , A-109, Austria
Algemeen Ziekenhuis Klina
Brasschaat , 2930, Belgium
Jolimont
Haine-St-Paul , 7100, Belgium
Az Groeninge
Kortrijk , 8500, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven , 3000, Belgium
Hospitais Integradaos da Gavea S/A-DF Star
Brasilia , 70390, Brazil
Instituto Joinvilense de Hematologia e Oncologia Ltda - Centro de Hematologia e Oncologia
Joinville , 89201, Brazil
Complexo Hospitalar de Niterói
Niterói , 24020, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22793, Brazil
Hospital Sao Rafael
Salvador , 41253, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base
Sao Jose do Rio Preto , 15090, Brazil
Hemomed
Sao Paulo , 01236, Brazil
Fundação Antônio Prudente - A.C. Camargo Cancer Center
Sao Paulo , 01509, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Sao Paulo , 04502, Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
São Paulo , 01308, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo , 01323, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo , 01327, Brazil
Clinica Sao Germano
São Paulo , 01455, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo , 05652, Brazil
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Saint John Regional Hospital
Saint John New Brunswick, E2L 4, Canada
Nova Scotia Health Authority
Halifax Nova Scotia, B3H 1, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Lakeridge Health Oshawa
Oshawa Ontario, L1G2B, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont
Montreal Quebec, H1T 2, Canada
Peking Union Medical College Hospital
Beijing , 10000, China
Beijing Chaoyang Hospital
Beijing , 10002, China
The First Bethune Hospital of Jilin University
Changchun , 13002, China
The Third Xiangya Hospital, Central South University
Changsha , 41001, China
Sichuan Provincial People's Hospital
Chengdu , 61003, China
Chongqing University Cancer Hospital
Chongqing , 40003, China
Fujian Meidical University Union Hospital
Fu Zhou , 35000, China
Sun Yat -Sen University Cancer Center
Guangzhou , 51006, China
First affiliated Hospital of Zhejiang University
Hangzhou , 31000, China
Harbin medical university cancer hospital
Harbin , 15008, China
The First Affiliated Hospital of NanChang University
Nanchang , 33000, China
Nanjing Drum Tower Hospital
Nanjing , 21000, China
First Affiliated Hospital of Guangxi Medical University
Nanning , 53002, China
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai , 20002, China
Shengjing Hospital of China Medical University
Shenyang , 11005, China
Shenzhen 2nd People's Hospital
Shenzhen , 51802, China
Institute of Hematology & Blood Diseases Hospital
Tian Jin , 30002, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou , 32500, China
Wuhan Union Hospital
Wuhan , 43002, China
Wuxi People's Hospital
Wuxi , 21402, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an , 71000, China
Henan Cancer Hospital
Zhengzhou , 45000, China
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Ostrava
Ostrava , 70852, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Aalborg University Hospital
Aalborg , 9000, Denmark
Rigshospitalet
Copenhagen , DK-21, Denmark
Regionshospitalet Gødstrup
Herning , 7400, Denmark
Vejle Sygehus
Vejle , 7100, Denmark
Hôpital Côte de Nacre
Caen cedex 9 , 14003, France
CHU Grenoble
Grenoble , 38700, France
Centre Hospitalier du Mans
Le Mans , 72000, France
Institut Paoli Calmettes
Marseille , 13009, France
CHU de Montpellier, Hopital Saint-Eloi
Montpellier , 34090, France
CHU Nantes
Nantes Cedex 1 , 44000, France
Hopital de la Pitie Salpetriere
Paris , 75013, France
Hôpital Necker Enfants Malades
Paris , 75743, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse , 31100, France
CHU de Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy , 54500, France
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus , 03048, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresdden , 01307, Germany
Universitätsmedizin Greifswald
Greifswald , 17475, Germany
Asklepios Klinik Altona
Hamburg , 22763, Germany
Universitätsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitatsmedizin Leipzig
Leipzig , 04103, Germany
Universitaetsklinikum Giessen und Marburg GmbH
Marburg , 35043, Germany
Universitätsklinikum Ulm
Ulm , 89070, Germany
Heinrich-Braun-Klinikum gGmbH
Zwickau , 08060, Germany
Alexandra General Hospital of Athens
Athens Attica , 115 2, Greece
Agios Andreas General Hospital of Patra
Patra , 263 3, Greece
'G. Papanikolaou' Hospital of Thessaloniki
Thessaloniki , 570 1, Greece
M S Ramaiah Medical College and Hospital
Bangalore , 56005, India
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh , 16001, India
Fortis Memorial Research Institute
Gurgaon , 12200, India
Medanta The Medicity
Gurugram , 12200, India
Bhagwan Mahaveer Cancer Hospital & Research Centre
Jaipur , 30201, India
Tata Medical Center
Kolkata , 70015, India
Tata Memorial Hospital
Mumbai , 40001, India
Kingsway Hospital
Nagpur , 44000, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry , 60500, India
Deenanath Mangeshkar Hospital and Research Centre
Pune , 41100, India
Bnai Zion Medical Center
Haifa , 31048, Israel
Carmel Medical Center
Haifa , 34362, Israel
Rabin Medical Center
Petah Tikva , 49100, Israel
Sheba Medical Center
Ramat Gan , 52621, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv-Yafo , 64239, Israel
A.O.U Sant'Orsola-Malpighi
Bologna , 40138, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano , 20133, Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo , 90127, Italy
Ospedale Santa Chiara AO Universitaria Pisana
Pisa , 56126, Italy
Campus Bio-Medico di Roma
Roma , 00128, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Presidio Molinette
Turin , 10126, Italy
ASUI Santa Maria della Misericordia di Udine
Udine , 33100, Italy
Ospedale di Circolo e Fondazione Macchi
Varese , 21100, Italy
Chiba Cancer Center
Chiba , 260-0, Japan
Ogaki Municipal Hospital
Gifu , 503-8, Japan
Hitachi General Hospital
Hitachi , 317-0, Japan
Saitama Medical University Hospital
Iruma-gun , 350-0, Japan
Kameda General Hospital
Kamogawa City , 296-0, Japan
Kurashiki Central Hospital
Kurashiki , 710-8, Japan
Matsuyama Red Cross Hospital
Matsuyama , 790-8, Japan
Aichi Medical University Hospital
Nagakute , 480-1, Japan
Niigata University Medical & Dental Hospital
Niigata , 951-8, Japan
National Hospital Organization Okayama Medical Center
Okayama , 701-1, Japan
Osaka Metropolitan University Hospital
Osaka , 545-8, Japan
Hokkaido University Hospital
Sapporo , 060-8, Japan
Juntendo University Hospital
Tokyo , 113-0, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Yamanashi Prefectural Central Hospital
Yamanashi , 400-8, Japan
Hospital Pulau Pinang
Georgetown , 10450, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu , 88200, Malaysia
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Subang Jaya Medical Centre
Subang Jaya , 47500, Malaysia
Meander Medisch Centrum
Amersfoort , 3818 , Netherlands
VUMC Amsterdam
Amsterdam , 1081 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9700 , Netherlands
UMC Utrecht
Utrecht , 3584 , Netherlands
Uniwersyteckie Centrum Medyczne
Gdansk , 80-21, Poland
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Szpital Uniwersytecki w Krakowie
Krakow , 31-50, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin , 20-08, Poland
Hosp. Garcia de Orta
Almada , 2805-, Portugal
Champalimaud Foundation Champalimaud Centre
Lisbon , 1400-, Portugal
Instituto Portugues de Oncologia
Porto , 42000, Portugal
Hospital de Vila Nova de Gaia E.P.E.
Vila Nova de Gaia , 4434-, Portugal
Instituto Catalan Deoncologia Hospital Duran I Reynals
Barcelona , 8908, Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera , 11407, Spain
Hosp. Univ. Infanta Leonor
Madrid , 28031, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hosp. Gral. Univ. J.M. Morales Meseguer
Murcia , 30008, Spain
Hosp. Univ. Central de Asturias
Oviedo , 33006, Spain
Hosp. Son Llatzer
Palma de Mallorca , 07198, Spain
Hosp. Montecelo
Pontevedra , 36071, Spain
Hosp. Univ. I Politecni La Fe-
Valencia , 46026, Spain
Falu Lasarett Medicinkliniken Falun
Falun , 791 8, Sweden
Helsingborgs lasarett
Helsingborg , 25287, Sweden
Linkoping University Hospital
Linköping , 58185, Sweden
Akademiska Sjukhuset
Uppsala , 751 8, Sweden
Ankara Gulhane Training and Research Hospital
Ankara , 06010, Turkey
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara , 06200, Turkey
Ankara University Medical Faculty
Ankara , 06620, Turkey
Antalya Training And Research Hospital
Antalya , 07100, Turkey
Ondokuz Mayis University
Atakum , 55280, Turkey
Medipol University Hospital
Istanbul , 34214, Turkey
Istanbul University Istanbul Medical Faculty
Istanbul , 34452, Turkey
Dokuz Eylul University Medical Faculty
Izmir , 35330, Turkey
Aberdeen Royal Infirmary
Aberdeen , AB25 , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham , B15 2, United Kingdom
Colchester Hospital University NHS
Colchester , CO4 5, United Kingdom
St George's Hospital
London , SW17 , United Kingdom
James Cook University Hospital
Middlesborough , Ts4 3, United Kingdom
Norfolk and Norwich University Hospital
Norwich , NR4 7, United Kingdom
Royal Stoke University Hospital
Staffordshire , ST4 6, United Kingdom
The Clatterbridge Cancer Centre
Wirral , CH63 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

590

Study ID:

NCT05572515

Recruitment Status:

Not yet recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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