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.
Who Can Participate?
Eligibility
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
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
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation
MajesTEC-4
MajesTEC-4
Principal Investigator
Cristina
Gasparetto
Protocol Number
PRO00118540
NCT ID
NCT05243797
Phase
III
Enrollment Status
Pending Open to Enrollment