Optimize First-line Treatment for AL Amyloidosis With t (11; 14)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJin Lu, MD
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of systemic AL amyloidosis;
Daratumumab, bortezomib, dexamethasone used in 1st line treatment;
Life expectancy greater than 12 weeks;
HGB ≥70g/L;
Disqualifiers
Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
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;
Trial design
Treatments tested in this trial
- Daratumumab
- Bortezomib
- Dexamethasone
- Venetoclax
Treatment groups
41 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jin Lu, MD
Lead sponsor
Peking University People's Hospital
Sponsor institution
Source ClinicalTrials.gov