Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis (NCT02816476) | Clinical Trial Compass
CompletedPhase 2
Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis
France40 participantsStarted 2016-09
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must be \>18 years of age
✓. Histologic diagnosis of AL amyloidosis
✓. Genetic testing must be negative for transthyretin mutations
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
✓. Patients should have received at least one line with an alkylating agent and/or a proteasome inhibitor and dexamethasone and not be in VGPR or CR at the time of inclusion
✓. Measurable hematologic disease:
✓. Symptomatic organ involvement
✓. Wash-out period of at least 4 weeks from previous antitumor therapy or any investigational treatment or 5 half-lives from previous antibodies, whichever is longer,
Exclusion criteria
✕. Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis