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Trial Title:
Bortezomib, Pomalidomide, Dexamethasone For Systemic AL Amyloidosis
NCT ID:
NCT06342466
Condition:
Systemic Amyloidosis
Conditions: Official terms:
Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Dexamethasone
Bortezomib
Pomalidomide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Bortezomib, pomalidomide, dexamethasone
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bortezomib
Description:
Bortezomib 1.3mg/m2 sc weekly
Arm group label:
BPd
Other name:
Velcade
Intervention type:
Drug
Intervention name:
Pomalidomide
Description:
4mg per day taken orally on 1-21 of repeated 28-day cycles
Arm group label:
BPd
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone 20mg-40mg weekly
Arm group label:
BPd
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.
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.
Criteria for eligibility:
Criteria:
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Yang Liu
Phone:
+8613716926210
Email:
pkuphliuyang@bjmu.edu.cn
Investigator:
Last name:
Jin Lu
Email:
Principal Investigator
Start date:
May 6, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Jin Lu, MD
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06342466
