RecruitingNot ApplicableNCT06192979

Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

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


Sponsor

Jin Lu, MD

Enrollment

41 participants

Start Date

Jan 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bortezomib, a drug called Daratumumab, and others for people with al amyloidosis and amyloidosis; systemic. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab

Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles. Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.

DRUGBortezomib

All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.

DRUGDexamethasone

All patients received 20-40 mg oral or intravenous dexamethasone

DRUGVenetoclax

All patients received venetoclax 400mg daily.


Locations(7)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Capital Medical University Affiliated Fuxing Hospital

Beijing, Beijing Municipality, China

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Chinese PLA Eastern Theater General Hospital

Nanjing, Jiangsu, China

Qilu Hospital of Shandong University (QingDao)

Qingdao, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, China

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NCT06192979


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