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Blood test may predict amyloidosis treatment success in days

NCT ID NCT06627309

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 99 years

Sex

Anyone

Healthy volunteers

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

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.

Immunoglobulin Light-chain Amyloidosis primary systemic amyloidosis

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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Anzhen Hospital

    RECRUITING

    Beijing, Beijing Municipality, 101118, China

  • Chinese PLA Eastern Theater General Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • First Affiliated Hospital of Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, China

  • Fuxing Hospital affiliated to Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100045, China

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    RECRUITING

    Xi'an, China

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