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New treatment option for Light Chain (AL) Amyloidosis
Official title Daratumumab for Patients With Light Chain Amyloidosis
ClinicalTrials.gov ID: NCT06376214
What this study is testing
What is Dratumumab / Hyaluronidase Injection [Darzalex Faspro]?
Dratumumab / Hyaluronidase Injection [Darzalex Faspro] is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for light chain (al) amyloidosis.
Also referred to as DARA.
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 is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants must be aged ≥18 and ≤75 years;
- Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));
- In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging...
- Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;
- Expected survival ≥ 12 weeks;
You likely can't join if
- eGFR\< 30ml/min/1.73m2;
- Combined multiple myeloma;
- Acute or chronic infection requiring treatment within 30 days prior to baseline;
- Pregnant or breastfeeding women.
- Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators.
- Other conditions deemed by the researcher as unsuitable for enrollment.
See the full eligibility criteria
- Participants must be aged ≥18 and ≤75 years;
- Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));
- In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP\>8500ng/L...
- Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;
- Expected survival ≥ 12 weeks;
- ECOG performance status≤ 2;
- Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or...
- eGFR\< 30ml/min/1.73m2;
- Combined multiple myeloma;
- Acute or chronic infection requiring treatment within 30 days prior to baseline;
- Pregnant or breastfeeding women.
- Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators.
- Other conditions deemed by the researcher as unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. 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.