Rapid dFLC Response Predict CHR in AL Amyloidosis

Last updated: March 6, 2026
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Treatment

Bortezomib (drug)

Cyclophosphamide (CTX)

Dara IV

Clinical Study ID

NCT06627309
2023PHB319-001-02
  • Ages 18-99
  • All Genders

Study Summary

Light chain amyloidosis (AL amyloidosis) is a rare plasma cell dyscrasia characterized by the deposition of insoluble amyloid fibrils in multiple organ systems. The treatment of amyloidosis primarily relies on anti-plasma cell therapy and supportive care. The application of anti-plasma cell therapy has significantly improved outcomes in patients with AL amyloidosis. Standard first-line therapy typically includes daratumumab, bortezomib, cyclophosphamide, and dexamethasone (Dara-BCD), achieving a complete hematologic response in nearly 60% of patients.The depth and speed of the hematologic response are strongly correlated with organ response and overall survival. An early achievement of a complete hematologic response is particularly crucial in cases of AL amyloidosis characterized by significant organ involvement. The median time to a hematologic response for the daratumumab based treatment is only 7-9 days. The retrospective data showed that the hematologic response in Day 7 in Cycle 1 (C1D7) may predict the complete hematologic response rate. In order to validate the conclusion, the investigator design this prospective study.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of systemic AL amyloidosis;

  2. Daratumumab, bortezomib, dexamethasone used in treatment;

  3. Informed consent explained to, understood by and signed by the patient;

  4. dFLC ≥ 50 mg/L;

Exclusion

Exclusion Criteria:

  1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacyticlymphoma;

  2. Presence of other tumors which is/are in advanced malignant stage and has/havesystemic metastasis;

  3. Severe or persistent infection that cannot be effectively controlled;

  4. Presence of severe autoimmune diseases or immunodeficiency disease;

  5. Patients with active hepatitis B or hepatitis C ([HBVDNA+] or [HCVRNA+]); Patientswith HIV infection or syphilis infection;

  6. Any situations that the researchers believe will increase the risks for the subjector affect the results of the study.

Study Design

Total Participants: 50
Treatment Group(s): 5
Primary Treatment: Bortezomib (drug)
Phase:
Study Start date:
October 26, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality 101118
    China

    Active - Recruiting

  • Fuxing Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality 100045
    China

    Active - Recruiting

  • Peking University First Hospital

    Beijing, Beijing Municipality
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality 100044
    China

    Active - Recruiting

  • First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • Chinese PLA Eastern Theater General Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an,
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.