EMN30/64007957MMY3003 MajesTEC-4 (Multiple Myeloma) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an investigational drug called teclistamab (the study drug) is a safe and effective option for people who have multiple myeloma and have achieved at least a partial response to standard therapy. We want to know how well it works on its own and in combination with a standard drug called lenalidomide.
Multiple Myeloma
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with multiple myeloma
- Have one of the following response types to treatment: clinical response or partial response suitable for observation
For more information about who can join this study, please contact the study team at quinna.marshburn@duke.edu.
What is Involved?
The study is divided into 3 periods: a pre-screening period, screening, and a study dosing period.
If you choose to join the study, you will go through a pre-screening period which lasts about 3-8 weeks. During this time, you will have a tissue biopsy and blood tests.
The screening period will follow next and may last up to 28 days. During this period, you will come in for visits to have the following procedures: echocardiogram, EKGs, physical exams, a CT and/or a PET scan, blood tests, and urine tests.
If you are found to be eligible after the screening period, you will move on to the study dosing period. During this period, you will get a random assignment (by chance) to 1 of 3 groups:
- Group 1: If you are in this group, you will get the study drug and take it in combination with lenalidomide.
- Group 2: If you are in this group, you will get lenalidomide on its own.
- Group 3: If you are in this group, you will only get the study drug.
Participation in the study will last for up to 2 years.
Study Details
