Myeloma patients who are transplant-ineligible might feel like their treatment options are limited, but good news is on the horizon. 

The Phase III (3) IMROZ trial has revealed a new potential therapy for those patients who don't qualify or opt out of a stem cell transplant in their beginning stages of therapy (newly diagnosed myeloma).  

Phase III IMROZ Trial Details and Outcomes 

The Phase 3 IMROZ trial tested adding Sarclisa^® (also known as isatuximab) in combination with the standard-of-care bortezomib (Velcade), lenalidomide (REVLIMID®) and dexamethasone (this combination is also known as VRd). 

The clinical trial met its primary endpoint of superior progression-free survival (PFS) compared with VRd alone. 

There were 484 patients enrolled in this trial across 104 centers and spanning 21 countries. Sarclisa was administered through an intravenous infusion at a dose of 10mg/kg once weekly for five weeks during the first 42-day cycle and once every two weeks in cycles 2-4 in combination with an injection of Velcade, an oral REVLIMID pill, and intravenous or oral dexamethasone. 

Then Sarclisa was administered every two weeks from cycles 5-17 and every four weeks in cycles 18+ during 28-day cycles in combination with lenalidomide and dexamethasone at the standard dose, until the disease progression, complicating side effects, or a decision from the patient to stop the treatment. 

According to the official announcement from Sanofi, Dr. Thierry Facon who led the IMROZ study shared,

"The IMROZ trial outcome is promising for patients with newly diagnosed multiple myeloma who are transplant-ineligible, as there remains a significant unmet need for potential new therapies.”

Conclusion

The exact study results have been submitted for presentation at an upcoming medical meeting. The FDA has not yet approved this therapy, but it is hopeful news for those newly diagnosed myeloma patients who will not receive a stem cell transplant as part of their induction therapy. More effective upfront therapies are needed in order to cure myeloma and prevent disease progression.