NCT06342466 Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis
| NCT ID | NCT06342466 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jin Lu, MD |
| Condition | Systemic Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2024-05-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Jin Lu
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06342466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Systemic Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06342466 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06342466 currently recruiting?
Yes, NCT06342466 is actively recruiting participants. Contact the research team at pkuphliuyang@vip.sina.com for enrollment information.
Where is the NCT06342466 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06342466 clinical trial?
NCT06342466 is sponsored by Jin Lu, MD. The principal investigator is Jin Lu at Peking University People's Hospital. The trial plans to enroll 40 participants.