Clinical trial · Interventional
Daratumumab for Patients With Light Chain Amyloidosis
Daratumumab and Dexamethasone Combined With Pomalidomide (DPD) or ASCT in the Treatment of Newly Diagnosed Systemic Light Chain Amyloidosis (AL Amyloidosis): a Prospective, Single Center Clinical Trial
- 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 a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis.
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 |
|---|---|---|---|
| Light Chain (AL) Amyloidosis | AL Amyloidosis | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous stem cell transplantation (ASCT) | Procedure | — | UNRESOLVED |
| Dratumumab / Hyaluronidase Injection [Darzalex Faspro] | Drug | — | UNRESOLVED |
| Pomalidomide 4 MG | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- long-term daratumumab treatment group (group A)
- description
- The patient will receive the standard protocol of daratumumab combined with dexamethasone treatment, once a week for the first two months, once every two weeks for four months, and then once a month for 18 months.
- interventionNames
- Drug: Dratumumab / Hyaluronidase Injection [Darzalex Faspro]
- type
- EXPERIMENTAL
- label
- daratumumab combine with ASCT treatment group (group B)
- description
- This group of patients will first receive two courses of treatment with the standard protocol of daratumumab combined with dexamethasone. Subsequent patients will receive ASCT treatment, and patients who achieve VGPR or CR after transplantation treatment will be followed up for observation
- interventionNames
- Drug: Dratumumab / Hyaluronidase Injection [Darzalex Faspro]
- Procedure: autologous stem cell transplantation (ASCT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants must be aged ≥18 and ≤75 years; 2. Newly diagnosed AL amyloidosis ((confirmed by pathological examination with at least one major organ involvement (heart, kidney, or liver)); 3. In group A and B, according to the Mayo 2004 staging system, the disease is classified as stage Ⅰ-ⅢA; In group C, according to the Mayo 2004 staging system, the disease is classified as stage IIIB: NT⁃proBNP\>8500ng/L and cTnT\>0.035μg/L or cTnI\>0.01g/L; 4. Participants must personally sign an informed consent form approved by the Ethics Committee before the start of the study; 5. Expected survival ≥ 12 weeks; 6. ECOG performance status≤ 2; 7. Female participants of childbearing potential must agree to use effective contraception from the day of signing the informed consent until 365 days after the infusion. Effective contraception is defined as abstinence or the use of a contraceptive method with a failure rate of \<1% per year. Exclusion Criteria: 1. eGFR\< 30ml/min/1.73m2; 2. Combined multiple myeloma; 3. Acute or chronic infection requiring treatment within 30 days prior to baseline; 4. Pregnant or breastfeeding women. 5. Participants known to have life-threatening allergic reactions, hypersensitivity, or intolerance to Monoclonal antibodies or immune modulators. 6. Other conditions deemed by the researcher as unsuitable for enrollment.
References
Publications (0)
Data not yet available