Blood test may predict amyloidosis treatment success in days
NCT ID NCT06627309
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether a rapid drop in a blood marker called dFLC can predict a complete response in people with AL amyloidosis treated with daratumumab-based therapy. Researchers will follow 50 patients to see if early changes in dFLC levels match up with later treatment success. The goal is to find a simple way to guide treatment decisions early on.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Daratumumab, bortezomib, and dexamethasone
- What this could lead to
- If successful, this could help doctors quickly tell if a patient is responding to treatment, allowing for faster adjustments and better outcomes.
- What could go wrong
- This is a small, early-stage study with only 50 participants. The blood marker may not reliably predict long-term response, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Systemic AL amyloidosis patients with evaluable hematologic parameter
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of systemic AL amyloidosis; 2. Daratumumab, bortezomib, dexamethasone used in treatment; 3. Informed consent explained to, understood by and signed by the patient; 4. dFLC ≥ 50 mg/L; Exclusion Criteria: 1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma; 2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; 3. Severe or persistent infection that cannot be effectively controlled; 4. Presence of severe autoimmune diseases or immunodeficiency disease; 5. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]); Patients with HIV infection or syphilis infection; 6. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Anzhen Hospital
RECRUITINGBeijing, Beijing Municipality, 101118, China
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Chinese PLA Eastern Theater General Hospital
RECRUITINGNanjing, Jiangsu, China
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First Affiliated Hospital of Harbin Medical University
RECRUITINGHarbin, Heilongjiang, China
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Fuxing Hospital affiliated to Capital Medical University
RECRUITINGBeijing, Beijing Municipality, 100045, China
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, China
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Peking University People's Hospital
RECRUITINGBeijing, Beijing Municipality, 100044, China
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Shengjing Hospital of China Medical University
RECRUITINGShenyang, Liaoning, China
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The First Affiliated Hospital of Xi'an Jiao Tong University
RECRUITINGXi'an, China
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