Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
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ClinicalTrials.gov Identifier: NCT05898646 |
Recruitment Status :
Recruiting
First Posted : June 12, 2023
Last Update Posted : January 17, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | June 2, 2023 | ||||
First Posted Date ICMJE | June 12, 2023 | ||||
Last Update Posted Date | January 17, 2024 | ||||
Actual Study Start Date ICMJE | July 17, 2023 | ||||
Estimated Primary Completion Date | November 1, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Event free survival [ Time Frame: From registration up to 36 months ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial | ||||
Official Title ICMJE | Phase II Study Evaluating Maintenance in Light Chain Amyloidosis (EMILIA) | ||||
Brief 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. | ||||
Detailed 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 each arm (organ response will be assessed based on organ-related values at diagnosis). IV. To determine time to next therapy (TTNT) after 3-6 versus 18 cycles daratumumab maintenance. V. To determine time to organ response in those who did not achieve organ response at trial registration. VI. To determine time to deep organ response based on revised organ response criteria for heart and kidneys. VII. To determine time to organ progression, defined as the time between registration to date of organ progression per organ progression criteria. VIII. To determine rate of pneumonia, sepsis and/or upper respiratory infections and any grade >= 3 infection in both arms within 3 years from registration. IX. To determine overall survival after 3-6 versus 18 cycles daratumumab maintenance. CORRELATIVE RESEARCH OBJECTIVE: I. To assess overall health-related quality of life, as measured by Patient Reported Outcomes Measurement Information System (PROMIS)-29 health questionnaire and selected items for the Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) questionnaire at registration, and at 3, 6, 12, 18 and 36 months from registration. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive daratumumab subcutaneously (SC) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 6 cycles on study. Patients also undergo x-ray imaging at screening and bone marrow biopsy and blood sample collection throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial. ARM II: Patients receive daratumumab SC on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 18 cycles on study. Patients also undergo x-ray imaging at screening and bone marrow biopsy and blood sample collection throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial. After completion of study treatment, patients are followed up every 6 months for up to 36 months from registration, and then up to 5 years from starting the study for survival status. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | AL Amyloidosis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
96 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | November 1, 2024 | ||||
Estimated Primary Completion Date | November 1, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05898646 | ||||
Other Study ID Numbers ICMJE | MC220802 NCI-2023-03819 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 22-011048 ( Other Identifier: Mayo Clinic Institutional Review Board ) MC220802 ( Other Identifier: Mayo Clinic ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Mayo Clinic | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Mayo Clinic | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Mayo Clinic | ||||
Verification Date | January 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |