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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Qilu Hospital of Shandong University (QingDao)
  Qingdao, Shandong, China Recruiting
• Qingdao Municipal Hospital
  Qingdao, Shandong, China Recruiting

Study contacts

• Principal investigator: Jin Lu — Peking University People's Hospital
• Study coordinator: Jin Lu
• Email: jin1lu@sina.com
• Phone: +8613311491805

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Belgian Amyloidosis Biobank and Patient Registry at UZ Leuven

  This project collects and stores blood, tissue samples, and medical data from adults with suspected or confirmed amyloidosis to create a biobank and registry for future research.

  Recruiting at 2 sites Universitaire Ziekenhuizen KU Leuven · Leuven and 1 other locations · NCT07172243

• Registry for patients with systemic amyloidosis

  This study is collecting information from patients with systemic amyloidosis to better understand the disease and how different treatments work over time.

  Recruiting University Hospital, Essen · Essen, North Rhine-Westphalia · NCT06887283

• Testing Belantamab Mafodotin for AL Amyloidosis

  This study is testing a new drug called Belantamab Mafodotin to see if it can safely help people with relapsed or hard-to-treat AL Amyloidosis feel better.

  Recruiting at 2 sites Phase 1/2 University of Texas Southwestern Medical Center · Nashville, Tennessee and 2 other locations · NCT05145816

• SMS text check-ins to track symptoms for people with plasma cell disorders

  This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07850284

• Acoramidis for ATTR-CM: Cardiac Imaging Study

  This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.

  Recruiting Phase 4 Eidos Therapeutics, a BridgeBio company · St Louis, Missouri · NCT07695701

• Hungarian National Systemic Amyloidosis Registry

  This registry collects medical data from adults with systemic amyloidosis across Hungary to help understand how the disease is diagnosed and treated in real-world practice.

  Recruiting at 12 sites Semmelweis University · Balatonfüred and 11 other locations · NCT07689331

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.