Last updated 16 days ago

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

590 patients around the world
Available in United States, Brazil, Spain
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.
Janssen Research & Development, LLC
16Research sites
590Patients around the world
This study is for people with
Multiple myeloma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Sites
Beneficência Portuguesa de São Paulo
Recruiting
R. Maestro Cardim, 637 - Bela Vista, São Paulo - SP, 01323-001
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Natal, Rio Grande Do Norte, 59075-740
Complexo Hospitalar de Niterói - CHN
Recruiting
Tv. Lasalle, 12 - Centro, Niterói - RJ, 24020-096
Instituto Americas - COI
Recruiting
Americas Medical City, Av. Jorge Curi, 550 - Bloco A, Sala 347 - Barra da Tijuca, Rio de Janeiro - RJ, 22775-001
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
Av. Brg. Faria Lima, 5544 Sao Jose do Rio Preto - Estado de São Paulo 15090-000
Sociedade Beneficente de Senhoras Hospital Sirio Libanes
Recruiting
R. Dr. Albuquerque Lins, 40 - Santa Cecilia, São Paulo - SP, 01230-001, Brazil
Fundação Antônio Prudente - CAPEC - Centro de Apoio à Pesquisa Clínica
Recruiting
R. Prof. Antônio Prudente, 212 - Liberdade, São Paulo - SP, 01509-010
AC Camargo Cancer Center
Recruiting
São Paulo, 01509-001
Hospital Alemão Oswaldo Cruz
Recruiting
R. Treze de Maio, 1815 - Bela Vista, São Paulo - SP, 01323-020, Brazil
Clinica São Germano
Recruiting
R. Comendador Miguel Calfat, 217 - Vila Nova Conceição, São Paulo - SP, 04537-080, Brazil
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