DREAMM-7 Study Design and the Rationale

The faculty describe the approval of belantamab mafodotin with bortezomib and dexamethasone for patients who have had at least 2 prior lines of treatment including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), noting the boxed warning for ocular adverse effects.

DREAMM-7 is characterized as a randomized, open-label phase 3 study comparing belantamab mafodotin with bortezomib and dexamethasone against a daratumumab-based combination of daratumumab, bortezomib, and dexamethasone, the regimen approved on the basis of the CASTOR trial. Belantamab mafodotin was given with dose adjustments and schedule modifications allowed. The first 8 cycles were given with bortezomib and dexamethasone, followed by belantamab mafodotin until progression. Most enrolled patients were in early lines. The primary endpoint was progression-free survival, with overall response rate, measurable residual disease (MRD) negativity, overall survival, and safety as important considerations. Turning to design, the faculty argue that control arms must be strong, contrasting DREAMM-7 with trials such as ASPIRE and TOURMALINE that compared a 3-drug regimen against a 2-drug regimen. CASTOR compared daratumumab, bortezomib, and dexamethasone against bortezomib and dexamethasone, and the expectation for that control arm is more than 15 months. The faculty proceed to further discuss the DREAMM-7 study’s treatment arms, dosing, and dosing schedules.