Daratumumab for Patients With Light Chain Amyloidosis

Light Chain (AL) Amyloidosis Clinical Trial

Official title:

Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective, Single Center Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06376214
• Other study ID #: 2024-02
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Amyloidosis
• Light Chain (AL) Amyloidosis

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