LPS18183: subcutaneous isatuximab (Relapsed/Refractory Multiple Myeloma) - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if an experimental technology is a safe and effective way to administer treatment for relapsed and/or refractory multiple myeloma (RRMM). We want to know if giving the drug isatuximab as an injection under the skin works as well as giving this same drug as an intravenous (IV) infusion. The drug combination of isatuximab, carfilzomib, and dexamethasone is approved for the treatment of RRMM, but the current standard of care is to give isatuximab through an IV.

¿Cuál es la Condición que se está estudiando?

Relapsed and/or Refractory Multiple Myeloma (RRMM)

¿Quién puede participar en el Estudio?

Adults ages 18+ who:

  • Are diagnosed with RRMM
  • Have attempted at least 1 previous line of therapy but not more than 3
  • Have no history of graft-versus-host disease following a blood stem cell transplant

For more information, contact the study team at jennifer.tichon@duke.edu.

Grupo etario
Adultos

¿Qué Implica?

If you choose to join this study, you will get the standard treatment isatuximab, carfilzomib, and dexamethasone. Carfilzomib will be given as an IV, and dexamethasone can be given as an IV or a pill that you take by mouth. However, instead of getting isatuximab as an IV, you will get a 1400 mg dose of the drug as an injection under the skin by using an experimental device that administers the drug.

Detalles del Estudio

Título Completo
A single-arm, open-label, Phase 2 study evaluating subcutaneous administration of isatuximab, administered by an On Body Delivery System, in combination with weekly carfilzomib and dexamethasone in adult participants with relapsed and/or refractory multiple myeloma (RRMM)
Investigador Principal
Cristiana Costa Chase, DO
Especialista en oncología hematológica
Número de Protocolo
IRB: PRO00117382
NCT: NCT06356571
Fase
Phase II
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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