Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

NCT ID: NCT06342466

Last Updated: 2024-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2026-12-31

Brief Summary

This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated 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.

Detailed 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.

Conditions

Systemic Amyloidosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BPd

BPd regimen (Bortezomib, pomalidomide, and dexamethasone) will be applied every 28 days until progression of disease, unacceptable toxicity or subsequent therapy, for a maximum of six cycles.

Group Type: EXPERIMENTAL

Bortezomib

Intervention Type: DRUG

Bortezomib 1.3mg/m2 sc weekly

Pomalidomide

Intervention Type: DRUG

4mg per day taken orally on 1-21 of repeated 28-day cycles

Dexamethasone

Intervention Type: DRUG

Dexamethasone 20mg-40mg weekly

Interventions

Bortezomib

Bortezomib 1.3mg/m2 sc weekly

Intervention Type: DRUG

Pomalidomide

4mg per day taken orally on 1-21 of repeated 28-day cycles

Intervention Type: DRUG

Dexamethasone

Dexamethasone 20mg-40mg weekly

Intervention Type: DRUG

Other Intervention Names

Velcade

Eligibility Criteria

Inclusion Criteria

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

2. Newly diagnosed or previous treated 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:

① 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).

②. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jin Lu, MD

OTHER

Sponsor Role: lead

Responsible Party

Jin Lu, MD

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jin Lu

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Liu, Dr

Role: CONTACT

Phone: 86-13716926210

Email: pkuphliuyang@vip.sina.com

Facility Contacts

Yang Liu

Role: primary

Jin Lu

Role: backup

Other Identifiers

2023-358-02

Identifier Type: -

Identifier Source: org_study_id