Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnant persons

Nursing persons

Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception

Received >1 cycle of daratumumab maintenance after end of induction therapy and prior to registration

Trial design

Treatments tested in this trial

  • Bone Marrow Aspiration
  • Daratumumab
  • Echocardiography Test
  • Questionnaire Administration
  • X-Ray Imaging
  • Biospecimen Collection

Treatment groups

96 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator