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

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05898646

Provider View

This study is exploring whether continuing treatment with the drug daratumumab for a shorter or longer period can help improve survival in patients with light chain amyloidosis, a condition where abnormal proteins build up in organs and tissues.

Patient Parameters

Program Overview

This phase II trial is comparing two different lengths of maintenance therapy using daratumumab to see which is more effective in helping patients with light chain (AL) amyloidosis live longer. Maintenance therapy is given to prevent cancer from returning after initial treatment. Daratumumab is a type of medication called a monoclonal antibody that targets a protein on certain cancer cells, helping the immune system destroy them. This study aims to find out if continuing daratumumab treatment for a shorter or longer time after initial therapy can improve survival in patients with AL amyloidosis.

Description

Primary Objective:

  • To find out how long patients live without their disease getting worse after receiving either 3-6 or 18 cycles of daratumumab maintenance therapy following initial treatment with a combination of daratumumab, cyclophosphamide, bortezomib, and dexamethasone (CyBorD) for newly diagnosed AL amyloidosis.

Secondary Objectives:

  • To measure the response of blood and bone marrow to the treatment at the end of maintenance.
  • To check for any remaining disease using advanced testing methods at the start and end of maintenance.
  • To evaluate how well organs affected by amyloidosis respond to treatment over time.
  • To determine how long it takes before patients need another therapy after completing daratumumab maintenance.
  • To assess the time it takes for organs to respond to treatment if they didn't initially respond.
  • To evaluate the time to a deeper organ response based on updated criteria for heart and kidneys.
  • To measure the time until organs show signs of disease progression.
  • To track the occurrence of serious infections like pneumonia or sepsis during the study.
  • To determine overall survival after completing either 3-6 or 18 cycles of daratumumab maintenance.

Correlative Research Objective:

  • To assess the overall quality of life of patients using specific health questionnaires at various points during the study.

Study Outline:

  • Arm I: Patients receive daratumumab under the skin on day 1 of each cycle, repeating every 28 days for up to 6 cycles, unless the disease progresses or side effects become unacceptable. Patients will also have x-rays, bone marrow biopsies, and blood tests throughout the study. Those with heart involvement will have echocardiograms.

  • Arm II: Patients receive daratumumab under the skin on day 1 of each cycle, repeating every 28 days for up to 18 cycles, unless the disease progresses or side effects become unacceptable. Patients will also have x-rays, bone marrow biopsies, and blood tests throughout the study. Those with heart involvement will have echocardiograms.

After completing the study treatment, patients will be followed up every 3 months for up to 36 months, and then up to 5 years to check their survival status.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of AL amyloidosis with organ disease that needs treatment.
  • Must have had specific protein studies done at diagnosis before starting initial treatment.
  • Must have completed 6 cycles of initial treatment with daratumumab and other drugs within 84 days before joining the study.
  • Must have shown a good response to initial treatment, either complete or partial, with or without organ response.
  • Must have received at least daratumumab and dexamethasone during initial treatment.
  • Must have a performance status score of 0, 1, 2, or 3, indicating varying levels of activity.
  • Must have adequate blood counts and organ function as determined by specific tests.
  • Must have a negative pregnancy test if of childbearing potential.
  • Must provide written informed consent and be willing to complete questionnaires and return for follow-up visits.

Exclusion Criteria

  • Cannot be pregnant or nursing, and must agree to use contraception if of childbearing potential.
  • Cannot have received more than one cycle of daratumumab maintenance after initial treatment.
  • Cannot have multiple myeloma at diagnosis, as defined by specific criteria like high calcium levels, kidney issues, anemia, or bone lesions.
  • Cannot be seropositive for hepatitis B unless certain conditions are met.
  • Cannot be immunocompromised or HIV positive and on antiretroviral therapy.
  • Cannot have uncontrolled illnesses or psychiatric conditions that would interfere with study participation.

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