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

AL Amyloidosis Amyloidosis; Systemic

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

Inclusion Criteria7

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 Criteria7

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;
Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
Patients with HIV infection or syphilis infection;
Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

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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.