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

What is the Purpose of this Study?

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.

What is the Condition Being Studied?

Relapsed and/or Refractory Multiple Myeloma (RRMM)

Who Can Participate in the Study?

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

What is Involved?

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.

Study Details

Full Title
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)
Principal Investigator
Especialista en oncología hematológica
Protocol Number
IRB: PRO00117382
NCT: NCT06356571
Phase
Phase II
ClinicalTrials.gov
Estado de inscripción
Pronto disponible para inscripción