Purpose of this Study
We are doing this study to find the safest and most effective dose of an experimental drug called Cilta-cel (the study drug) in patients with multiple myeloma (MM).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are newly diagnosed with multiple myeloma
- Are transplant eligible
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 a random assignment (like a coin flip) to 1 of 2 study regimens.
GROUP A: If you are in this group, you will get the standard treatment for your diagnosis.
- You will get 4 cycles (28-day periods) of induction chemotherapy using the drugs daratumumab and bortezomib.
- 4-6 weeks after you finish induction chemotherapy, you will get treatment to stimulate the production of bone marrow stem cells and then have these cells collected.
- 1-2 weeks after your stem cells are collected, you will get a high dose of a drug called melphalan and then have your stem cells returned to your body.
- After your stem cell transplant, you will get another 2 cycles of treatment with daratumumab and bortezomib.
- After your final doses of daratumumab and bortezomib, you will get a drug called lenalidomide every 4 weeks for as long as the study doctor believes you need it.
- Before starting the study regimen, you will have some of your white blood cells collected through a process called apheresis. Your collected white blood cells will be shipped to a CAR-T cell lab to be genetically modified and made into the study drug.
- You will get 6 cycles (28-day periods) of induction chemotherapy using the drugs bortezomib, lenalidomide, and dexamethasone or using bortezomib, cyclophosphamide, and dexamethasone (the study doctor will choose whichever combination they believe is most appropriate).
- You will get a single dose of the study drug after you finish the induction chemotherapy.
- After your dose of the study drug, you will get lenalidomide every 4 weeks for as long as the study doctor believes you need it.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible
Principal Investigator
Yubin
Kang
Protocol Number
PRO00115135
NCT ID
NCT05257083
Phase
III
Enrollment Status
Pending Open to Enrollment