Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis
Status:
Completed
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
Summary
This is a Phase II, single-arm, multicentre study of Daratumumab (16mg/kg IV route) in adult
patients with Light-Chain (AL) Amyloidosis who are not in VGPR or better after previous
treatment. A sample size of 40 patients who meet all eligibility criteria will be enrolled to
receive study treatment. Patients will receive treatment until either disease progression or
toxicity has occurred with a maximum planned of six 28-day cycles.
Daratumumab will be administrated every week for the first 2 cycles then. every 2 weeks from
cycle 3 through cycle 6.
Patients will also receive best supportive care (BSC) to mitigate Daratumumab side-effects,
and to address underlying Amyloidosis, including blood product transfusions, antimicrobials,
and (as appropriate) growth factors including granulocyte colony-stimulating factors for
neutropenia, erythropoietin for anaemia, and/or transfusions for thrombocytopenia