Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in AL patients with favorable safety profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax combined with daratumumab and dexamethasone in untreated AL amyloidosis patients.

Eligibility criteria

Qualifiers

Biopsy proved treatment-naïve AL amyloidosis

Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%

dFLC > 50mg/L

Disqualifiers

Co-morbidity of uncontrolled infection

Co-morbidity of other active malignancy

Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia

Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)

Trial design

Treatments tested in this trial

  • Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)
  • Venetoclax
  • Dexamethasone

Treatment groups

36 Participants
are divided into 1 treatment group