Phase II Study Evaluating Maintenance in Light Chain Amyloidosis (EMILIA)
Mayo Clinic
Summary
This phase II trial compares shorter-duration versus longer-duration maintenance therapy with daratumumab for improving survival in patients who have received initial treatment with daratumumab for light chain (AL) amyloidosis. Maintenance therapy is treatment that is given to help keep cancer from coming back after it has disappeared following initial therapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Daratumumab is commonly prescribed as initial treatment for patients with AL amyloidosis. However, it is not known what role daratumumab may play in the maintenance therapy period of patients with AL amyloidosis. This phase II trial compares shorter duration maintenance to longer duration maintenance for improving survival in patients with AL amyloidosis.
Description
PRIMARY OBJECTIVE: I. To determine the event-free survival (EFS) after 3-6 versus 18 cycles of daratumumab maintenance following 6 cycles induction of daratumumab-cyclophosphamide-bortezomib-dexamethasone (CyBorD) in newly diagnosed AL amyloidosis. SECONDARY OBJECTIVES: I. To determine the rate of hematological response at end of maintenance in each arm. II. To assess minimal residual disease rates by next generation multiparametric flow cytometry at study registration and at the end maintenance. III. To determine organ response rate at 6, 12, 18, 24 and 36 months from registration in eac…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \>= 18 years * Histological confirmation of AL amyloidosis with adequate typing (mass spectrometry, immunohistochemistry, immunofluorescence, immunogold) * AL amyloidosis with organ disease requiring therapy * NOTE: Disease requiring therapy is referred to the time of diagnosis. There are no limitations in baseline measurable disease parameters * Patients must have monoclonal protein studies (serum free light chain assay, serum immunofixation or serum MASS-FIX) obtained at time of diagnosis before induction therapy initiated and available for review to be enrolled…
Interventions
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- BiologicalDaratumumab
Given SC
- ProcedureEchocardiography Test
Undergo echocardiography
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureX-Ray Imaging
Undergo x-ray imaging
- ProcedureBiospecimen Collection
Undergo blood sample collection
Locations (2)
- Mayo Clinic in ArizonaScottsdale, Arizona
- Mayo Clinic in RochesterRochester, Minnesota