Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

Condition(s) studied

Investigational drug(s) / intervention(s)

Daratumumab: Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles. Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.

Bortezomib: All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.

Dexamethasone: All patients received 20-40 mg oral or intravenous dexamethasone

Venetoclax: All patients received venetoclax 400mg daily.

Study summary

Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.

Eligibility

Primary outcome measure(s)

• Overall CHR rate at 6 months — Overall CHR rate at 6 months
  Overall complete hematologic response rate at 6 months

Trial sites (7)

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