Criteria to qualify for study: Drug used in study:
  • Newly diagnosed AL amyloidosis. Diagnosis will be based on histopathological or electron microscopy criteria, one or more organs need to be affected, and disease must be measured by free light chain criteria. Eligible subjects will have an ECOG performance score of 0, 1, or 2 and adequate organ function.

AMY 05 54767414AMY3001

A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) compared with CyBorD alone in newly diagnosed Systemic AL Amylodosis.

Criteria to qualify for study: Drug used in study:
  • One prior line of therapy (defined as either one non-transplant regimen such as Mel-Dex of Vel-Dex or CyBorD.
  • One autologous stem cell transplant or one regimen of non-transplant induction therapy followed by a single autologous stem cell transplant (without hematologic progression between induction and ASCT).
  • Measuable hematologic disease as defined by serum differential free light chain concentration (Dflc, difference between amyloid forming [involved] and nonamyloid forming [uninvolved] free light chain [FLC] >50mg/L). Key exclusion criteria include Amyloidosis due to mutations of the transthyretin gene.

AMY 06 2016-200

Randomized Phase 2 trial of Lenalidomide/Dexamethasone/Elotuzumab +/- Cyclophosphamide followed by Lenalidomide/Dexamethasone/Elotuzumab maintenance as second-line therapy for patients with relapsed AL Amyloidosis.