- Patients with a confirmed diagnosis of newly diagnosed multiple myeloma
- Presence of high-risk cytogenetics using fluorescent in situ hybridization (FISH)
- Patients are allowed to have received one cycle of bortezomib-based doublet or triplet therapy
- Patients of childbearing potential must use approved contraception methods and if female, have a negative pregnancy test prior to starting treatment.
Detailed eligibility will be discussed when reaching out to the study team.
This study is being done to find out how the combination of selinexor, daratumumab, bortezomib and dexamethasone (Dara-SVD) compares to the standard of care treatment of daratumumab, lenalidomide, bortezomib, dexamethasone (Dara-RVD) in achieving good response in newly diagnosed multiple myeloma. The standard of care is the treatment most patients who are not in a study receive.
The study drug combination is considered investigational, which means it is not approved by the U.S. Food and Drug Administration (FDA). The standard of care treatment is FDA approved for multiple myeloma.
Participants will be randomized into one of two treatment groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.
One group will receive selinexor, daratumumab, bortezomib, and dexamethasone study drugs for up to 4 cycles of 28 days, and the other will receive the usual standard treatment with lenalidomide, daratumumab, bortezomib, and dexamethasone for up to 4 cycles.
Selinexor, lenalidomide and dexamethasone are taken orally and bortezomib and daratumumab are administered through the skin. In addition to receiving treatment, participants in both groups will also need to visit the clinic for blood tests, physical examinations, and other tests throughout the study.
Total study participation is expected to last 16 weeks. Participants will continue to be followed for 24 months.