Bortezomib, Pomalidomide, Dexamethasone For Systemic AL Amyloidosis

Systemic Amyloidosis Clinical Trial

Official title:

A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients With Systemic AL Amyloidosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342466
• Other study ID #: 2023-358-02
• Status: Recruiting
• Phase: Phase 2
• Start date: May 6, 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Peking University People's Hospital
• Contact: Yang Liu, Dr
• Phone: 86-13716926210
• Email: pkuphliuyang[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.

Description:

Proteasome inhibitor and immunmodulators have synergistic effect for plasma cell dyscrasia. Due to the fact that more than 70-80% of patients with amyloidosis have renal involvement, the application of lenalidomide is limited. Thus, the investigators designed this open-label, multicenter, phase 2 study for newly diagnosed or previously treated systemic AL amyloidosis with bortezomib, pomalidomide and dexamethasone regimen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.

2. Newly diagnosed AL amyloidosis

3. Patients must be = 18 years of age.

4. ECOG performance status 0, 1 or 2.

5. Measurable disease defined by at least one of the following:

? serum free light chain (FLC) =2.0 mg/dL (20 mg/L) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) =2mg/dL (20 mg/L).

?. presence of a monoclonal spike that is =5 g/l.

6. Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).

7. Absolute neutrophil count (ANC) =1.0 X 10^9/L, Hemoglobin =70 g/L, Platelets =50 X 10^9/L

8. eGFR =20 mL/min/ 1.73 m^2

9. Written informed consent in accordance with local and institutional guidelines.

10. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.

2. Presence of other tumors which is/are in advanced malignant stage and has/have systemic 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+]);

6. Patients with HIV infection or syphilis infection;

7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Related Conditions & MeSH terms

• Amyloidosis
• Immunoglobulin Light-chain Amyloidosis
• Systemic Amyloidosis

Intervention

Drug:
• Bortezomib
Bortezomib 1.3mg/m2 sc weekly
• Pomalidomide
4mg per day taken orally on 1-21 of repeated 28-day cycles
• Dexamethasone
Dexamethasone 20mg-40mg weekly

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jin Lu, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic VGPR + CR rate at 6 months	Hematologic very good partial response plus complete response rate at 6 months	6 months
Secondary	Overall Hematologic response rate at 6 months	Overall Hematologic partial response, very good partial response rate and complete response at 6 months	6 months
Secondary	At least one organ response at 6 months	At least one organ response (cardiac response, renal response, liver response) at 6 months	6 months
Secondary	TTNT at 2 years	Time to next treatment at 2 years	2 years
Secondary	Estimated PFS at 2 years	Estimated Progression free survival at 2 years	2 years
Secondary	Estimated OS at 2 years	Estimated Overall Survival at 2 years	2 years
Secondary	TRAE	Treatment-related adverse events up to 6 months	6 months