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Recruiting NCT06192979

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

No phase Interventional Amyloidosis; Systemic AL Amyloidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Daratumumab, Bortezomib, Dexamethasone, Venetoclax.
Who it may be relevant to
Registry conditions: Amyloidosis; Systemic, AL Amyloidosis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

The goal of this clinical trial is to optimize the first line treatment for systemic AL amyloidosis with t(11;14). The aim of this study is to pursue early complete hematologic response. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months. Participants will be treated according to the hematologic response after 7 days. If the patient get rapid response after 7 days, he/she will receive daratumumab, venetoclax and dexamethasone (DBD) for at least 6 cycles. If the patient do not get rapid response, he/she will receive daratumumab, venetoclax and dexamethasone.

Interventions

  • Drug Daratumumab
    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.
  • Drug Bortezomib
    All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.
  • Drug Dexamethasone
    All patients received 20-40 mg oral or intravenous dexamethasone
  • Drug Venetoclax
    All patients received venetoclax 400mg daily.

Primary outcome measures

  • Overall CHR rate at 6 months [Time frame: Overall CHR rate at 6 months]
Secondary outcome measures (7)
  • Cardiac response at 6 months [Time frame: Cardiac response at 6 months]
  • Renal response at 6 months [Time frame: Renal response at 6 months]
  • Hepatic response at 6 months [Time frame: Hepatic response at 6 months]
  • Estimated 2-year PFS [Time frame: Estimated 2-year PFS]
  • Estimated 2-year OS [Time frame: Estimated 2-year overall survival]
  • MRD status at 6 months [Time frame: MRD status at 6 months]
  • TRAEs [Time frame: TRAEs]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 7 centers
  • Peking University People's Hospital — Beijing
  • Capital Medical University Affiliated Fuxing Hospital — Beijing
  • Beijing Anzhen Hospital — Beijing
  • Chinese PLA Eastern Theater General Hospital — Nanjing
  • Qilu Hospital of Shandong University (QingDao) — Qingdao
  • Qingdao Municipal Hospital — Qingdao
  • The First Affiliated Hospital of Xi'an Jiao Tong University — Xi’an

Identifiers

NCT: NCT06192979 · 2023PHB319-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗