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:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 103 Locations for this study

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University of California, Irvine
Orange California, 92868, United States
PIH Health Hospital
Whittier California, 90602, United States
Cleveland Clinic Florida
Weston Florida, 33331, United States
St. Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
Box Hill Hospital
Melbourne , 3128, Australia
Fiona Stanley Hospital
Murdoch , 6150, Australia
Algemeen Ziekenhuis Klina
Brasschaat , 2930, Belgium
Jolimont
Haine-St-Paul , 7100, Belgium
Az Groeninge
Kortrijk , 8500, Belgium
Universitair Ziekenhuis Gasthuisberg
Leuven , 3000, Belgium
Liga Norte Riograndense Contra O Cancer
Natal , 59062, Brazil
Complexo Hospitalar de Niterói
Niteroi , 24020, Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro , 22775, Brazil
Sociedade Beneficente de Senhoras - Hospital Sírio Libanês
Sao Paulo , 01308, Brazil
Fundacao Antonio Prudente - A.C. Camargo Cancer Center
Sao Paulo , 01509, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Sao Paulo , 04501, Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo , 01321, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo , 01323, Brazil
The Third Xiangya Hospital, Central South University
Changsha , 41001, China
Sichuan Provincial People's Hospital
Chengdu , 61003, China
Sun Yat -Sen University Cancer Center
Guangzhou , 51006, China
First affiliated Hospital of Zhejiang University
Hangzhou , 31000, China
The First Affiliated Hospital of NanChang University
Nanchang , 33000, China
Institute of Hematology & Blood Diseases Hospital
Tian Jin , 30002, 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
Fakultni nemocnice Brno
Brno , 625 0, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba , 708 5, 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
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
Dresden , 01307, Germany
Universitätsmedizin Greifswald
Greifswald , 17475, Germany
Asklepios Klinik Altona
Hamburg , 22763, 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
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
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
Campus Bio-Medico di Roma
Roma , 00128, Italy
ASUI Santa Maria della Misericordia di Udine
Udine , 33100, Italy
Ospedale di Circolo e Fondazione Macchi
Varese , 21100, Italy
Ogaki Municipal Hospital
Gifu , 503-8, Japan
Kansai Medical University Hospital
Hirakata , 573-1, Japan
Hitachi General Hospital
Hitachi , 317-0, Japan
Saitama Medical University Hospital
Iruma-gun , 350-0, Japan
Kameda General Hospital
Kamogawa City , 296-8, Japan
Kurashiki Central Hospital
Kurashiki , 710-8, Japan
Matsuyama Red Cross Hospital
Matsuyama , 790-8, Japan
JRC Nagasaki Genbaku Hospital
Nagasaki-Shi , 852-8, 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 , 3813 , Netherlands
Universitair Medisch Centrum Groningen
Groningen , 9700 , Netherlands
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-21, Poland
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin , 20-08, Poland
Institut Catala d'Oncologia L'Hospitalet
Hospitalet de Llobregat , 08908, 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
Hospital Universitario Central de Asturias
Oviedo , 33011, Spain
Hosp. Son Llatzer
Palma de Mallorca , 07198, Spain
Hosp. Montecelo
Pontevedra , 36071, Spain
Hospital Universitari i Politecnic La Fe
València , 46026, Spain
Falu Lasarett Medicinkliniken Falun
Falun , 791 8, Sweden
Helsingborgs lasarett
Helsingborg , 25287, Sweden
Akademiska Sjukhuset
Uppsala , 751 8, Sweden

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:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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