Selinexor, Daratumumab, and Dexamethasone (XDd) for Light-Chain Cardiac Amyloidosis
Starting soon · Phase 2
Conditions studied: Light-chain Cardiac Amyloidosis
In brief
The goal of this clinical trial is to evaluate whether selinexor combined with daratumumab and dexamethasone (XDd) can treat patients with advanced light-chain cardiac amyloidosis. The main questions it aims to answer are: Does XDd regimen achieve hematologic complete response in patients with advanced light-chain cardiac amyloidosis? Does XDd regimen improve cardiac response, organ response, progression-free survival, overall survival, quality of life, and safety?
Key facts
- Study ID
- NCT07743957
- Run by
- Beijing Anzhen Hospital
- People needed
- 63
- Starts
- 2026-07-13
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years.
- Confirmed systemic light-chain amyloidosis, meeting both of the following:
- Tissue biopsy confirms amyloid deposition, and the amyloid precursor protein is immunoglobulin light chain or heavy-light chain. Pathologic evidence includes at least one of the following: Congo red staining positive with apple-green birefringence under polarized light microscopy; Light-chain restricted expression demonstrated by immunohistochemistry, immunofluorescence, or immunoelectron microscopy, or mass spectrometry confirming the precursor protein as immunoglobulin light chain; Electron microscopy showing nonbranching, rigid, randomly arranged fibrils with a diameter of 8 to 14 nm.
- Evidence of monoclonal immunoglobulin or free light chain in serum or urine, or detection of monoclonal plasma cells/B cells in bone marrow examination.
- Clinical manifestations, physical examination, laboratory tests, or imaging studies confirm involvement of one or more organs, with mandatory cardiac involvement. Cardiac involvement is defined as either:
- Mean ventricular wall thickness > 12 mm on echocardiography, with other cardiac diseases excluded; or
- NT-proBNP > 332 ng/L in the absence of renal insufficiency and atrial fibrillation.
- Mayo 2004 stage IIIa or IIIb disease, including newly diagnosed and relapsed/refractory patients.
- Measurable disease in light-chain amyloidosis, defined by at least one of the following:
- Serum monoclonal protein ≥ 0.5 g/dL by serum protein electrophoresis and immunofixation performed by the central laboratory;
- Serum free light chain ≥ 50 mg/L with an abnormal kappa/lambda ratio; or
- Difference between involved and uninvolved free light chains (dFLC) ≥ 50 mg/L. Note: Urine Bence Jones proteinuria alone is not sufficient to define measurable disease for eligibility.
- Not pregnant or breastfeeding. Men and women of childbearing potential must agree to use appropriate contraception before treatment, during treatment, during any treatment interruption, and for 4 weeks after treatment completion.
- Written informed consent has been signed by the participant. If the participant is unable to sign because of their medical condition, informed consent may be signed by a legal guardian or immediate family member.
You may not qualify if…
- Active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or other acquired or congenital immunodeficiency disorders.
- Baseline peripheral neuropathy or neuropathic pain of grade ≥ 2 according to NCI CTCAE v4.0.
- Major surgery within 30 days before enrollment.
- Epilepsy requiring medication, dementia, or other psychiatric conditions that prevent understanding of or compliance with the study protocol.
- Any severe physical or psychiatric illness that may interfere with participation in this clinical study.
- Any other condition that the investigator considers unsuitable for enrollment.
Full record on ClinicalTrials.gov
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