Daratumumab Combined With Bortezomib and Dexamethasone in Mayo 04 Stage III Light Chain Amyloidosis
Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
Patients with light chain (AL) amyloidosis who have advanced cardiac damage are at risk of
premature mortality. There is ongoing unmet need for effective therapies to rapidly induce
deep hematologic response and decrease the early death rate. Lately, trials of daratumumab in
newly-diagnosed and relapsed/refractory AL amyloidosis have shown dramatic response rates.
However, the benefits of upfront daratumumab in stage III AL patients, especially stage IIIb
patients, have not yet been demonstrated definitely in prospective studies. Therefore, we
designed a phase II, single arm clinical trial to investigate the efficacy and safety of
co-administration of daratumumab with bortezomib and dexamethasone (BD) regimen in
treatment-naïve patients with Mayo 04 stage III AL amyloidosis. We planned to enroll 40
patients, who would receive daratumumab and BD treatment for a total duration of 12 months.
The primary endpoint is complete response and very good partial response at 3 months after
treatment initiation. Secondary endpoints include overall survival, organ response and
adverse events.