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New treatment option for AL Amyloidosis
Official title Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
ClinicalTrials.gov ID: NCT05898646
What this study is testing
What is Daratumumab?
Daratumumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for al amyloidosis.
Also referred to as Daratumumab Biosimilar HLX15, Darzalex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 36 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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:
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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...
- 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)
- 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:
- Hypercalcemia: Serum calcium \> 1 mg/dL higher than upper limit of normal or \> 11 mg/dL
- Renal insufficiency: Creatinine clearance \ 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: people with resolved infection (i.e., people who are HBsAg negative but positive for antibodies to hepatitis B...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 36 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.