Using daratumumab to treat patients with light chain amyloidosis

Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective, Single Center Clinical Trial

This study is testing how well daratumumab works for treating light chain amyloidosis in different groups of patients to find the best way to help them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing University School of Medicine (Academic / other)
• Drugs / interventions: daratumumab
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06376214 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of daratumumab in patients diagnosed with light chain amyloidosis. Participants are divided into three groups: one receiving long-term daratumumab treatment, another undergoing autologous stem cell transplantation after initial daratumumab treatment, and a third group consisting of newly diagnosed stage IIIb patients receiving a combination of daratumumab, dexamethasone, and pomalidomide. The treatment regimen involves intravenous daratumumab infusions followed by regular disease evaluations. The study aims to determine the best treatment approach for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed light chain amyloidosis and at least one major organ involvement.

Not a fit: Patients with severely impaired kidney function (eGFR < 30 ml/min) may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with light chain amyloidosis.

How similar studies have performed: Other studies have shown promise with daratumumab in similar conditions, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Participants must be aged ≥18 and ≤75 years;
2. Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver));
3. 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 and cTnT\>0.035μg/L or cTnI\>0.01g/L;
4. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study;
5. Expected survival ≥ 12 weeks;
6. ECOG performance status≤ 2;
7. 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 the use of a contraceptive method with a failure rate of \<1% per year.

Exclusion Criteria:

1. eGFR\< 30ml/min/1.73m2;
2. Combined multiple myeloma;
3. Acute or chronic infection requiring treatment within 30 days prior to baseline;
4. Pregnant or breastfeeding women.
5. Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators.
6. Other conditions deemed by the researcher as unsuitable for enrollment.

Where this trial is running

Nanjing, Jiangsu

• National Clinical Research Center for Kidney Diseases, Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Xianghua Huang, MD — Jinling Hospital, China
• Study coordinator: Xianghua Huang, MD

Conditions Light Chain Amyloidosis; light chain amyloidosis; daratumumab; stem cell transplantation