Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

NCT06342466 | Recruiting Phase 2

• 1 other identifier: 2023-358-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Amyloidosis

Outcome Measures

Primary Outcomes (1)

• Hematologic VGPR + CR rate at 6 months

  Hematologic very good partial response plus complete response rate at 6 months

  6 months

Secondary Outcomes (6)

• Overall Hematologic response rate at 6 months

  6 months

• At least one organ response at 6 months

  6 months

• TTNT at 2 years

  2 years

• Estimated PFS at 2 years

  2 years

• Estimated OS at 2 years

  2 years

Study Arms (1)

BPd

EXPERIMENTAL

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.

Drug: Bortezomib; Drug: Pomalidomide; Drug: Dexamethasone

Interventions

Bortezomib DRUG

Bortezomib 1.3mg/m2 sc weekly

Also known as: Velcade

BPd

Pomalidomide DRUG

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

BPd

Dexamethasone DRUG

Dexamethasone 20mg-40mg weekly

BPd

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.
• Newly diagnosed or previous treated AL amyloidosis
• Patients must be ≥ 18 years of age.
• ECOG performance status 0, 1 or 2.
• 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.
• Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system).
• Absolute neutrophil count (ANC) ≥1.0 X 10\^9/L, Hemoglobin ≥70 g/L, Platelets ≥50 X 10\^9/L
• eGFR ≥20 mL/min/ 1.73 m\^2
• Written informed consent in accordance with local and institutional guidelines.
• Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if:

• Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
• Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
• Severe or persistent infection that cannot be effectively controlled;
• Presence of severe autoimmune diseases or immunodeficiency disease;
• Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
• Patients with HIV infection or syphilis infection;
• Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

Sponsors & Collaborators

• Jin Lu, MD: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Interventions

Bortezomib; pomalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jin Lu

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Liu, Dr

CONTACT

86-13716926210; pkuphliuyang@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Bortezomib, pomalidomide, dexamethasone

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 2, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)