NCT06342466RecruitingPhase 2
Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis
A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients with Systemic AL Amyloidosis
Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 19 Mar 2024
- Start date
- 6 May 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Jin Lu, MD
- Diseases
- Amyloidosis
- NCT number
- NCT06342466
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 6 May 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
- Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.