Lancet Oncology Recently published reports updating the findings from the phase 3 DREAMM 7 trial involving 494 patients averaging ages 64.5 years with the median follow-up of 39.4 months.

Accordingly, patients from the DREAM7 trial are now qualified to be participants in a Phase 3 study that demonstrates a triplet-based regimen of Dexamethasone, Bortezomib, and Belantam Mafodotin, instead of a DVd based regimen.

Outcomes

Vania Hungria M.D. Department of Hematology, São Paulo, Brazil, the lead author of the study, noted that with respect to PFS2 progression, events occurred in 38% of the BVd arm and 50% of the DVd arm.  Investigators reported serious fatal Adverse Events in eleven percent of the BVd arm as opposed to eight percent of the DVd arm.

Dr. Hungria, representing the team, said that to their knowledge the study indicates strong overall survival against established standards of care.  Baseline characteristics were balanced.  Low platelets, (Thrombocytopenia) were most frequently reported having occurred in 56% of the BVd arm and 35% of the DVd arm.

The FDA Oncologic Committee

The FDA Advisory Drug Committee voted five to three against BVd to treat patients who have multiple myeloma and at least one previous line of therapy.