Study on Subcutaneous Isatuximab with Weekly Carfilzomib and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma
Sponsor: Sanofi
ClinicalTrials ID:NCT06356571
This clinical trial is testing a new combination of medications, including subcutaneous isatuximab, carfilzomib, and dexamethasone, to see if it can help treat adults with multiple myeloma that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The main goal of this study is to find out how effective a new treatment combination is for adults with relapsed or refractory multiple myeloma (RRMM) who have already tried 1 to 3 different treatments. The treatment includes isatuximab given under the skin, along with carfilzomib and dexamethasone, to see if it can improve the overall response rate in these patients.
Description
Participants in this study will go through a screening period of up to 28 days to determine eligibility. Each treatment cycle lasts 28 days. After stopping the study treatment, participants will have a follow-up visit 30 days after their last dose or before starting any new myeloma treatment, whichever happens first.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of multiple myeloma.
- Must have measurable disease, which means having certain levels of specific proteins in the blood or urine.
- Must have tried at least one but no more than three previous treatments for multiple myeloma.
- Must agree to use effective birth control methods during the study and for a specified time after treatment ends.
- Must be able to provide informed consent to participate in the study.
Exclusion Criteria
- Cannot have primary refractory multiple myeloma, meaning the disease has never responded to any treatment.
- Cannot have had anti-CD38 treatment within 6 months before starting the study or have had a bad reaction to it.
- Cannot have been treated with carfilzomib before.
- Cannot have allergies to certain ingredients in the study medications that cannot be managed with premedication.
- Cannot have contraindications to dexamethasone or carfilzomib.
- Cannot have received any anti-myeloma treatment within 14 days before starting the study.
- Cannot have had a stem cell transplant with active graft versus host disease.
- Cannot have had major procedures or live vaccines shortly before starting the study.
- Must be deemed suitable for participation by the study doctor, without any medical conditions that could interfere with the study.
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