Trial reportBritish journal of haematology2026
Daratumumab plus bortezomib and dexamethasone (Dara-VD) in newly diagnosed Mayo 2004 stage IIIA and IIIB light-chain amyloidosis: Long-term follow-up results from a prospective phase 2 study.
Trial report in British journal of haematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Anti-CD38 monoclonal antibodies dramatically improve the prognosis in immunoglobulin light-chain (AL) amyloidosis, yet patients with end-stage (Mayo 2004 IIIB) disease are typically excluded from prospective trials. To evaluate the daratumumab plus bortezomib and dexamethasone (Dara-VD) regimen in Mayo 2004 stage III patients, we conducted a prospective phase 2 trial including 20 stage IIIA and 20 stage IIIB patients. The long-term follow-up results are reported here. The 24-month haematological complete response (CR) and very good partial response (VGPR) rate were 52.5% and 12.5% respectively. Organ responses improved after 12 months; the 24-month cardiac CR and VGPR rates were 15.0% and 35.0%. After a median follow-up of 50.9 months, 16 patients died and 10 patients had progressive diseases. The median overall survival (OS) had not been reached in either group, with a 4-year OS rate of 60.0% (95% confidence interval [CI]: 45.2%-75.2%). The median event-free survival (EFS) was 33.5 months (95% CI 21.0-46.0 months), with a 4-year EFS rate of 37.5% (95% CI: 24.3-54.7). No significant difference in OS or EFS was observed between stage IIIA and IIIB patients. In conclusion, the strong anti-plasma cell regimen Dara-VD provides comparable long-term responses and prognosis for Mayo stage IIIB patients.
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