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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Cristiana Costa
Chase
Protocol Number
PRO00117382
Phase
II
Enrollment Status
Pending Open to Enrollment