Testing venetoclax with daratumumab and dexamethasone in AL amyloidosis with t(11;14)
Tests venetoclax with daratumumab and dexamethasone in adults with AL amyloidosis.
Plain-language title generated from the registry record
Registry title: Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Key facts
- Where
- Beijing, Nanjing, Qingdao, and Xi’an, ChinaSee the 7 sites
Where in China
- Beijing Anzhen HospitalBeijing, ChinaTaking people
- Capital Medical University Affiliated Fuxing HospitalBeijing, ChinaTaking people
- Peking University People's HospitalBeijing, ChinaTaking people
- Chinese PLA Eastern Theater General HospitalNanjing, ChinaTaking people
- Qilu Hospital of Shandong University (Qingdao)Qingdao, ChinaTaking people
- QingDao Municipal HospitalQingdao, ChinaTaking people
- The First Affiliated Hospital of Xi'an Jiao Tong UniversityXi’an, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jin Lu, MD
- Trial code
- NCT06192979
- Record updated
- 7 July 2026
- Original description
Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.Read full original descriptionShow less
Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)
Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.
Inclusion: Diagnosis of systemic AL amyloidosis; Daratumumab, bortezomib, dexamethasone used in 1st line treatment; Life expectancy greater than 12 weeks; HGB ≥70g/L; Blood oxygen saturation >90%; Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN; Informed consent explained to, understood by and signed by the patient.
Exclusion: Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; Severe or persistent infection that cannot be effectively controlled; Presence of severe autoimmune diseases or immunodeficiency disease; Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]); Patients with HIV infection or syphilis infection; Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma; Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.