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 - EMN28 – EMagine / 68284528MMY3005- CARTITUDE-6

UVA Tracking #
300010
Principal Investigator
Laahn H Foster
Contact
Contact Phone
Official Trial 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
Study Description

The University of Virginia Comprehensive Cancer Center is participating to the EMN28-Emagine/CARTITUDE-6 study that is for participants ages 18 and over with Newly Diagnosed Multiple Myeloma who are Transplant Eligible and have had no prior treatment. This is a large, global study investigating the use ciltacabtagene autoleucel (cilta-cel) versus autologous stem cell transplantation (ASCT), which is the current standard of care. Cilta-cel is a B-cell maturation antigen (BCMA) directed CAR-T cell therapy, for which your white blood cells (which are a part of the immune system) will be genetically modified to target BCMA and will be used to treat your multiple myeloma.

In this study, patients will be first treated with standard chemotherapy with daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) followed by either ASCT or cilta-cel. Cilta-cel is currently approved as 5th line therapy for patients with relapsed, refractory disease and it has been shown to be very effective in this population. This study is investigating earlier use of cilta-cel in patients with newly diagnosed myeloma. There may or may not be any benefit to you; however, this study may help doctors learn if cilta-cel may be used as part of first-line therapy for multiple myeloma and will help other people in the future.

Treatment will be continuous for a maximum of 2 years (unless your study doctor believes that extending the duration of maintenance therapy will benefit you then you may receive it until your disease comes back/progresses). In the post-study treatment follow-up phase, visits for laboratory assessments will continue to occur every 4 weeks until you are 2 years after the start of your post-CAR-T therapy phase; thereafter, they will occur every 4 or 8 weeks until the disease comes back or progresses, to gather information about how your myeloma responds.

Additional information found here: https://www.clinicaltrials.gov/study/NCT05257083?titles=CARTITUDE-6&ran…

For questions, contact:
uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation