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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06376214
Other study ID # 2024-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source Nanjing University School of Medicine
Contact Xianghua Huang, MD
Phone 02580862351
Email hxhszb@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.


Description:

This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen (group A) and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen (group B) , and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment (group C). Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression. Group C were given Daratumumab (16mg/kg), dexamethasone (40mg) and pomalidomide. The usage of Daratumumab and dexamethasone is the same as group A and B. Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6. The dose of pomalidomide is adjusted based on the patient's renal function and ECOG score.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Participants must be aged =18 and =75 years; 2. Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver)); 3. In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage ?-?A; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT?proBNP>8500ng/L and cTnT>0.035µg/L or cTnI>0.01g/L; 4. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study; 5. Expected survival = 12 weeks; 6. ECOG performance status= 2; 7. Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of <1% per year. Exclusion Criteria: 1. eGFR< 30ml/min/1.73m2; 2. Combined multiple myeloma; 3. Acute or chronic infection requiring treatment within 30 days prior to baseline; 4. Pregnant or breastfeeding women. 5. Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators. 6. Other conditions deemed by the researcher as unsuitable for enrollment.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dratumumab / Hyaluronidase Injection [Darzalex Faspro]
Daratumumab will be administered at the FDA-approved dose of 16mg/kg as an intravenous infusion.
Pomalidomide 4 MG
Patients received oral pomalidomide on days 1-21 of a 28-days cycle from cycle 1 to 6.
Procedure:
autologous stem cell transplantation (ASCT)
The ASCT protocol included mobilisation with colony-stimulating factor alone and conditioning with high-dose melphalan140-200 mg/m2 .

Locations

Country Name City State
China National Clinical Research Center for Kidney Diseases, Jinling Hospital Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hematological complete response rate the 6 months overall hematologic complete response rate after treatment. 6 months
Primary Organ response rate the 1-year organ response rate after treatment 1 year
Secondary Time to Next Treatment Number of months from study drug initiation to starting another treatment 3 years
Secondary Progression-free survival the 3 years progression-free survival after treatment 3 years
Secondary Overall survival the 5 years overall survival after treatment 5 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05996406 - Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14) Phase 2
Withdrawn NCT05692908 - An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis Phase 1
Withdrawn NCT04943302 - Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis Phase 2
Not yet recruiting NCT06097832 - Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis Phase 1
Recruiting NCT05486481 - Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE) Phase 1/Phase 2
Recruiting NCT04973137 - A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis Phase 3
Completed NCT02015312 - A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL) Phase 2
Recruiting NCT04316442 - Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis Phase 1/Phase 2