AbbVie: M15-538 (Multiple Myeloma)
What is the Purpose of this Study?
If you choose to join this study, you will go through a screening period to see if you are eligible. During this period, you will:
- Have a physical exam
- Have blood draws
- Give urine samples
- Have a heart scan (ECG or echocardiogram)
- Have a bone marrow biopsy
We will test your bone marrow for a certain genetic marker called t(11;14). You must be positive for t(11;14) to be eligible to proceed.
If you are eligible to proceed in the study, you will be be assigned to 1 of 3 treatment arms:
- Arm A: lower dose of the study drug in combination with carfilzomib + dexamethasone
- Arm B: higher dose of the study drug in combination with carfilzomib + dexamethasone
- Arm C: carfilzomib + dexamethasone alone
Participation in each arm of the study will last for up to 72 weeks.
- Have a physical exam
- Have blood draws
- Give urine samples
- Have a heart scan (ECG or echocardiogram)
- Have a bone marrow biopsy
We will test your bone marrow for a certain genetic marker called t(11;14). You must be positive for t(11;14) to be eligible to proceed.
If you are eligible to proceed in the study, you will be be assigned to 1 of 3 treatment arms:
- Arm A: lower dose of the study drug in combination with carfilzomib + dexamethasone
- Arm B: higher dose of the study drug in combination with carfilzomib + dexamethasone
- Arm C: carfilzomib + dexamethasone alone
Participation in each arm of the study will last for up to 72 weeks.
What is the Condition Being Studied?
Relapsed/Refractory Multiple Myeloma
Who Can Participate in this Study?
Adults ages 18+ who:
- Have multiple myeloma that is not responding to therapy; OR
- Have multiple myeloma that has come back after previous therapy
- Are positive for a genetic marker called t(11;14)
For more information about who can join this study, please contact the study team 919-668-0613.
Age Group
Adults
Participating Institutions
What is Involved?
We are doing this study to find out if an experimental study drug called venetoclax (Venclexta) is a safe and effective treatment for relapsed or refractory multiple myeloma. We want to see if people have better outcomes when they're treated with the study drug and standard drugs, carfilzomib (Kyprolis) and dexamethasone, versus just the standard drugs on their own.
Study Details
Full Title
A Phase 2, Open-Label, Multi-Center Study of Venetoclax in Combination with Carfilzomib and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
Principal Investigator
Protocol Number
IRB:
PRO00082035
NCT:
NCT02899052
ClinicalTrials.gov
View on ClinicalTrials.gov