Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 and up

Daratumumab maintenance therapy for AL amyloidosis

Official title: Phase II Study Evaluating Maintenance in Light Chain Amyloidosis (EMILIA)

Run by Mayo Clinic · NCT05898646 · Data updated 2026-11-12

This study tests whether shorter or longer maintenance therapy with daratumumab helps people with light chain amyloidosis stay healthy after their initial treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment96 (estimated)
SponsorMayo Clinic
Academic / other
Drugs / interventionsdaratumumab, cyclophosphamide
Locations2 sites (Scottsdale, Arizona and 1 other locations)
StatusRecruiting
StartedSeptember 6, 2023
Main results expectedNovember 30, 2029
Study endsNovember 30, 2031
Registry record updatedOctober 1, 2026
Trial IDNCT05898646 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with histologically confirmed AL amyloidosis requiring therapy and who have completed initial daratumumab-based treatment.

Probably not a fit

Patients who do not have AL amyloidosis or those who have not received prior daratumumab treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial investigates the effectiveness of shorter versus longer durations of daratumumab maintenance therapy in patients with light chain amyloidosis who have previously undergone initial treatment with daratumumab. The study aims to determine event-free survival and other key outcomes such as hematological response rates and organ response rates after different maintenance durations. Participants will be monitored for various health metrics, including overall survival and quality of life, as they receive either 3-6 or 18 cycles of maintenance therapy. The trial seeks to clarify the role of daratumumab in maintaining remission for this patient population.

Why it matters

Potential benefit: If successful, this study could improve survival rates and quality of life for patients with AL amyloidosis.

How similar studies have gone: Other studies have shown promise with daratumumab in treating AL amyloidosis, but this specific maintenance approach is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion 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 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
* 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)

Exclusion Criteria:

* 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 \< 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

Where it's running

  • Mayo Clinic in Arizona
    Scottsdale, Arizona, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.