Optimizing first-line treatment for AL amyloidosis with specific genetic markers

Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)

This study is testing a new treatment plan for people with AL amyloidosis who have a specific genetic marker to see if it helps them respond better and faster to their first-line therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: Daratumumab
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT06192979 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to enhance the first-line treatment for systemic AL amyloidosis in patients with the t(11;14) genetic abnormality. Participants will initially receive a combination of daratumumab, bortezomib, and dexamethasone (DBD) for at least 6 cycles if they show a rapid hematologic response within 7 days. If they do not respond quickly, they will switch to a different regimen including daratumumab, venetoclax, and dexamethasone. The primary goal is to achieve a complete hematologic response within 6 months.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with systemic AL amyloidosis who have the t(11;14) genetic abnormality and meet specific health criteria.

Not a fit: Patients with active multiple myeloma, severe infections, or other advanced malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with AL amyloidosis, particularly those with the t(11;14) genetic marker.

How similar studies have performed: While there have been studies on AL amyloidosis treatments, this specific approach targeting the t(11;14) genetic marker is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of systemic AL amyloidosis;
2. Daratumumab, bortezomib, dexamethasone used in 1st line treatment;
3. Life expectancy greater than 12 weeks;
4. HGB ≥70g/L;
5. Blood oxygen saturation \>90%;
6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
7. Informed consent explained to, understood by and signed by the patient.

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 \[HCVRNA+\]);
6. Patients with HIV infection or syphilis infection;
7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Where this trial is running

Beijing, Beijing Municipality and 5 other locations

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Capital Medical University Affiliated Fuxing Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Chinese PLA Eastern Theater General Hospital — Nanjing, Jiangsu, China (Recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi’an, Shanxi, China (Recruiting)

Study contacts

• Principal investigator: Jin Lu — Peking University People's Hospital
• Study coordinator: Jin Lu

Conditions Amyloidosis; Systemic; AL Amyloidosis; t(11; 14); Rapid Response; AL amyloidosis