Clinical trial · Interventional
Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis
A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients with Systemic AL Amyloidosis
NCT06342466CI-TRIAL-00084192recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Systemic Amyloidosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BPd
- description
- 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.
- interventionNames
- Drug: Bortezomib
- Drug: Pomalidomide
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Hematologic VGPR + CR rate at 6 months
- timeFrame
- 6 months
- description
- Hematologic very good partial response plus complete response rate at 6 months
Secondary outcomes (6)
- measure
- Overall Hematologic response rate at 6 months
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.