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

ConditionAL Amyloidosis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration

  • Daratumumab

    Biological/Vaccine

    Given SC

  • Echocardiography Test

    Procedure/Surgery

    Undergo echocardiography

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • X-Ray Imaging

    Procedure/Surgery

    Undergo x-ray imaging

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Arm I (6 cycles of daratumumab)Experimental treatment 6 interventions
Group B: Arm II (18 cycles of daratumumab)Active comparator 6 interventions

Trial outcomes

Primary outcomes

1

Event free survival

The point estimate for the hazard ratio and corresponding one-sided 85% confidence interval will be generated with a stratified Cox regression (using the trial stratification factors) that has treatment arm as an exploratory variable.

Time frame
From registration up to 36 months

Secondary outcomes

1

Hematological response

A success is defined as a complete response (CR), very good partial response (VGPR) and partial response (PR). Hematological response must be maintained or improved during maintenance. Loss of level of hematological response (i.e., CR to VGPR/PR/progressive disease \[PD\], VGPR to PR/PD or PR to PD) will be considered a failure. The rate of hematological response will be defined as the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportions will be calculated. All responses will be assessed and compared to values at diagnosis (and not at trial registration).

Time frame
At the end of maintenance treatment
2

Minimal residual disease (MRD) negativity rate

Will be estimated by the number of successes divided by the total number of evaluable patients who consented for MRD assessment. Exact binomial 95% confidence intervals for the true success proportions will be calculated.

Time frame
Up to 36 months
3

Organ response rates

Cardiac, renal, and hepatic response rates will be evaluated separately. The rate of organ response will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportions will be calculated. All responses will be assessed and compared to values at diagnosis (and not at trial registration)

Time frame
At 6, 12, 18, 24, and 36 months from registration
4

Overall survival (OS)

Median OS will be estimated using the Kaplan-Meier method. Patients who do not experience death while on study will be censored at the last known date alive. The median OS and corresponding 95% confidence interval will be reported by arm (6 vs. 18 cycles of daratumumab maintenance).

Time frame
Time from registration to death from any cause, assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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