Purpose of this Study
We are doing this study to find out if the drugs talquetamab and teclistamab are a safe and effective option for people with multiple myeloma that has come back after treatment (relapsed) or is not improving with treatment (refractory).
Who Can Participate?
Eligibility
Adults ages 18+ who are diagnosed with relapsed or refractory multiple myeloma.
For more information about who can join this study, please contact the study team at quinna.marshburn@duke.edu.
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 three periods: screening period, study dosing period, and a safety follow-up period.
If you choose to join this study, during the screening period you will:
- Have a tumor biopsy
- Have imaging scans (CT, MRI, and echocardiogram)
- Have physical exams and blood draws
- Arm A: If you are in this arm, you will get a regimen of both talquetamab and pomalidomide (Tal-P).
- Arm B: If you are in this arm, you will get a regimen of both talquetamab and teclistamab (Tal-Tec).
- Arm C: If you are in this arm, you will get a regimen of elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd).
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3 Randomized Study Comparing Talquetamab in Combination with Pomalidomide (Tal-P), Talquetamab in Combination with Teclistamab (Tal-Tec), and Investigator’s Choice of Either Elotuzumab, Pomalidomide, and Dexamethasone (EPd) or Pomalidomide, Bortezomib, and Dexamethasone (PVd) in Participants with Relapsed or Refractory Myeloma who Have Received 1 to 4 Prior Lines of Therapy Including an Anti-CD38 Antibody and Lenalidomide
Principal Investigator
Yubin
Kang
Protocol Number
PRO00116532
NCT ID
NCT06208150
Phase
III
Enrollment Status
Pending Open to Enrollment