EMN30/64007957MMY3003 MajesTEC-4 (Multiple Myeloma) - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if an investigational drug called teclistamab (the study drug) is a safe and effective option for people who have multiple myeloma and have achieved at least a partial response to standard therapy. We want to know how well it works on its own and in combination with a standard drug called lenalidomide.

¿Cuál es la Condición que se está estudiando?

Mieloma múltiple

¿Quién puede participar en el Estudio?

Adults ages 18+ who:

  • Are diagnosed with multiple myeloma
  • Have one of the following response types to treatment: clinical response or partial response suitable for observation

For more information about who can join this study, please contact the study team at quinna.marshburn@duke.edu.

Grupo etario
Adultos

¿Qué Implica?

The study is divided into 3 periods: a pre-screening period, screening, and a study dosing period.

If you choose to join the study, you will go through a pre-screening period which lasts about 3-8 weeks. During this time, you will have a tissue biopsy and blood tests.

The screening period will follow next and may last up to 28 days. During this period, you will come in for visits to have the following procedures: echocardiogram, EKGs, physical exams, a CT and/or a PET scan, blood tests, and urine tests.

If you are found to be eligible after the screening period, you will move on to the study dosing period. During this period, you will get a random assignment (by chance) to 1 of 3 groups:

  • Group 1: If you are in this group, you will get the study drug and take it in combination with lenalidomide.
  • Group 2: If you are in this group, you will get lenalidomide on its own.
  • Group 3: If you are in this group, you will only get the study drug.

Participation in the study will last for up to 2 years.

Detalles del Estudio

Título Completo
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation MajesTEC-4
Investigador Principal
Especialista en terapia celular
Número de Protocolo
IRB: PRO00118540
NCT: NCT05243797
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción