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

Sponsor
Jin Lu, MD
Study ID
NCT06192979
Status
Recruiting
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Conditions

  • AL Amyloidosis
  • Amyloidosis; Systemic

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    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 — DRUG
    All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.
  • Dexamethasone — DRUG
    All patients received 20-40 mg oral or intravenous dexamethasone
  • Venetoclax — DRUG
    All patients received venetoclax 400mg daily.

Study Details

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.

Key Dates

Start date
Jan 5, 2024
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
41 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Rapid Response Group
    Daratumumab, bortezomib, dexamethasone
  • Other: Non-Rapid Response Group
    Daratumumab, venetoclax, dexamethasone

Primary Outcome Measure

Overall CHR rate at 6 months [ Time Frame: Overall CHR rate at 6 months ]

Central Contacts

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