AL AmyloidosisPhase 2NCT05898646
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
A Phase 2 study testing Bone Marrow Aspiration, Daratumumab and Echocardiography Test in people with AL Amyloidosis, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AL Amyloidosis
- What is being tested?
- Bone Marrow Aspiration, Daratumumab and Echocardiography Test
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Sep 2023to 30 Nov 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- NOTE: Patients are allowed to participate in this study if urine electrophoresis immunofixation study was not done at time of diagnosis or cannot be obtained
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- Patients must have completed 6 cycles of daratumumab (Dara)-CyBorD-based induction treatment prior to registration or have a plan to complete cycle 6 prior to cycle 1 day 1. NOTE: treatment in the study is allowed only after the completion of 6 cycles of induction
- Patients must have achieved a hematological complete response (CR) (irrespective of organ response achievement) or hematological very good partial response (VGPR) (irrespective of organ response achievement) or hematological low-difference in involved and uninvolved free light chain (dFLC) partial response (PR) (irrespective of organ response achievement) or hematological PR with at least one organ response after receiving Dara-CyBorD-based induction.
- NOTE: Patients with baseline dFLC < 5 mg/dL, must have achieved hematological CR, or dFLC < 1 mg/dL or achieved organ response prior to randomization
- Patients in whom bortezomib and/or cyclophosphamide were omitted from induction due to toxicity concerns or adverse effects are allowed. Patients must receive at least daratumumab and dexamethasone at induction to qualify for the study
- NOTE: Dexamethasone use does not need to be carried to end of induction for eligibility consideration
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3
- Hemoglobin >= 8.0 g/dL (obtained =< 28 days prior to registration)
- Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 28 days prior to registration)
- Platelet count >= 50,000/mm^3 (obtained =< 28 days prior to registration)
- Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only.
- NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Provide written informed consent
- NOTE: Informed consent required =< 90 days prior registration
- Ability to complete questionnaire(s) by themselves or with assistance
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Who cannot join
- Any of the following because this study involves an agent that has possible genotoxic, mutagenic and teratogenic effects:
- 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
- Multiple myeloma at time of diagnosis as defined by any of the following:
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- Hypercalcemia: Serum calcium > 1 mg/dL higher than upper limit of normal or > 11 mg/dL
- Renal insufficiency: Creatinine clearance < 40 mL per min or serum creatinine > 2 mg/dL attributed to high circulating light chains (i.e. cast nephropathy) or hypercalcemia
- Anemia: Hemoglobin > 2 g/dL below lower limit of normal, or < 10 g/dL, attributed to high marrow myeloma infiltration
- Bone lesions: >= 1 osteolytic lesion on skeletal x-ray, computed tomography (CT), or positron emission tomography (PET)-CT (bone imaging is not mandatory but based on clinical suspicion)
- Clonal bone marrow plasma cells >= 60%
- > 1 focal lesion on magnetic resonance imaging (MRI) (MRI is not mandatory but based on clinical suspicion)
- If bone imaging (CT, MRI, PET-CT) was not done at time of diagnosis it is not needed to be performed at registration to rule out bone disease
- >= 40% BMPCs irrespective of the above
- The study will allow patients with involved: uninvolved serum-free light chain (sFLC) ratio >= 100 if this is the only criteria that defines amyloidosis if all the above criteria are not met
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Note: Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
- NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Unstable angina pectoris
- Psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Taxiarchis Kourelis, MD
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clincal Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Udit Yadav, MBBS
About this study
Official title: Phase II Study Evaluating Maintenance in Light Chain Amyloidosis (EMILIA)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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:
- 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 undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy 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 undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial.
After completion of study treatment, patients are followed up every 3 months for up to 36 months from registration, and then up to 5 years from starting the study for survival status.
- Conditions
- AL Amyloidosis
- Being tested
- Bone Marrow Aspiration, Daratumumab, Echocardiography Test, Questionnaire Administration, X-Ray Imaging
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration
DaratumumabBiological
Also called Daratumumab Biosimilar HLX15, Darzalex, HLX15, HuMax-CD38
Given SC
Echocardiography TestProcedure or surgery
Also called EC, Echocardiography
Undergo echocardiography
Questionnaire AdministrationOther
Ancillary studies
X-Ray ImagingProcedure or surgery
Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs
Undergo x-ray imaging
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Arm I (6 cycles of daratumumab) | Experimental | 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 undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial. Receives: Procedure: Bone Marrow Aspiration; Biological: Daratumumab; Procedure: Echocardiography Test; Other: Questionnaire Administration; Procedure: X-Ray Imaging; Procedure: Biospecimen Collection |
| Arm II (18 cycles of daratumumab) | Active comparator | 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 undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial. Receives: Procedure: Bone Marrow Aspiration; Biological: Daratumumab; Procedure: Echocardiography Test; Other: Questionnaire Administration; Procedure: X-Ray Imaging; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From registration up to 36 months
Secondary outcomes (4)
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).
Measured: At the end of maintenance treatment
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.
Measured: Up to 36 months
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)
Measured: At 6, 12, 18, 24, and 36 months from registration
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).
Measured: Time from registration to death from any cause, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start6 Sep 2023
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AL AmyloidosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Taxiarchis Kourelis, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898646
- Sponsor's protocol ID
- MC220802
- Other IDs
- R21CA288898, 22-011048
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2023
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating Maintenance in Light Chain Amyloidosis (EMILIA)
- ClinicalTrials.gov ID
- NCT05898646
- Acronym / sponsor ID
- MC220802
- Conditions
- AL Amyloidosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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:
- 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 undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy 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 undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial.
After completion of study treatment, patients are followed up every 3 months for up to 36 months from registration, and then up to 5 years from starting the study for survival status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (6 cycles of daratumumab) | Experimental | Procedure: Bone Marrow Aspiration, Biological: Daratumumab, Procedure: Echocardiography Test, Other: Questionnaire Administration, Procedure: X-Ray Imaging, Procedure: Biospecimen CollectionPatients 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 undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial. |
| Arm II (18 cycles of daratumumab) | Active comparator | Procedure: Bone Marrow Aspiration, Biological: Daratumumab, Procedure: Echocardiography Test, Other: Questionnaire Administration, Procedure: X-Ray Imaging, Procedure: Biospecimen CollectionPatients 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 undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age >= 18 years
- Histological confirmation of AL amyloidosis with adequate typing (mass spectrometry, immunohistochemistry, immunofluorescence, immunogold)
- AL amyloidosis with organ disease requiring therapy
- 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.
- Patients must have completed 6 cycles of daratumumab (Dara)-CyBorD-based induction treatment prior to registration or have a plan to complete cycle 6 prior to cycle 1 day 1. NOTE: treatment in the study is allowed only after the completion of 6 cycles of induction
Key exclusion criteria (22 listed)
- Any of the following because this study involves an agent that has possible genotoxic, mutagenic and teratogenic effects:
- Received >1 cycle of daratumumab maintenance after end of induction therapy and prior to registration
- Multiple myeloma at time of diagnosis as defined by any of the following:
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Note: Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow AspirationUndergo bone marrow aspiration | Procedure or surgery | Arm I (6 cycles of daratumumab), Arm II (18 cycles of daratumumab) |
| DaratumumabAlso: Daratumumab Biosimilar HLX15, Darzalex, HLX15, HuMax-CD38Given SC | Biological | Arm I (6 cycles of daratumumab), Arm II (18 cycles of daratumumab) |
| Echocardiography TestAlso: EC, EchocardiographyUndergo echocardiography | Procedure or surgery | Arm I (6 cycles of daratumumab), Arm II (18 cycles of daratumumab) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (6 cycles of daratumumab), Arm II (18 cycles of daratumumab) |
| X-Ray ImagingAlso: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographsUndergo x-ray imaging | Procedure or surgery | Arm I (6 cycles of daratumumab), Arm II (18 cycles of daratumumab) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm I (6 cycles of daratumumab), Arm II (18 cycles of daratumumab) |
Primary outcome
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.
4 secondary outcomes
Hematological response
Time frame: At the end of maintenance treatment
Minimal residual disease (MRD) negativity rate
Time frame: Up to 36 months
Organ response rates
Time frame: At 6, 12, 18, 24, and 36 months from registration
Overall survival (OS)
Time frame: Time from registration to death from any cause, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taxiarchis Kourelis, MD principal investigator
Mayo Clinic in Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bone Marrow Aspiration, Daratumumab and Echocardiography Test in people with AL Amyloidosis, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: From registration up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.