Iberdomide Maintenance Vs Lenalidomide Maintenance Following ASCT (Multiple Myeloma) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find the most effective, safe dose of an experimental drug called iberdomide (the study drug). We want to know how well this study drug works in people with multiple myeloma when compared with a drug called lenalidomide after an autologous stem cell transplant.

What is the Condition Being Studied?

Newly Diagnosed Multiple Myeloma (NDMM)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with symptomatic MM
  • Have received an autologous stem cell transplant
  • Do not have progressive disease or clinical relapse following stem cell transplant
  • Do not have smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma
  • Do not have known central nervous system/meningeal involvement of MM

Para obtener más información sobre quién puede participar en este estudio, comuníquese con el equipo del estudio al 919-668-1026.

Grupo etario
Adultos

What is Involved?

Si decide unirse a este estudio, pasará por un período de detección para determinar si es elegible. Durante este período de detección, usted:

  • Hacer un examen físico
  • Hacerse un escáner del corazón (ECG)
  • Realizar extracciones de sangre
  • Provide urine samples

If you are eligible to join the study, you will get a random assignment (like a coin flip) to one of two different groups:

  • One group will take a regimen of the study drug
  • The other group will take a drug call lenalidomide

If you are assigned to the study drug group, you will take the study drug by mouth every day for the first 21 days of each 28-day drug cycle. The dose of the study drug that you get will depend on when you enter the study.

If you are assigned to get lenalidomide, you will take this drug every day. Your dose of lenalidomide will start at 10 mg once daily, and the study doctor might increase this dose to 15 mg after 3 cycles if they believe you will get a benefit from the change.

The total study drug regimen may take up to approximately 4 years, but this can vary depending on how you respond to the study drug.

Study Details

Full Title
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM)
Principal Investigator
Especialista en terapia celular
Protocol Number
IRB: PRO00113837
NCT: NCT05827016
Phase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción