ClinicalTrials.gov record NCT07743957
Selinexor, Daratumumab, and Dexamethasone (XDd) for Light-Chain Cardiac Amyloidosis
Selinexor Combined With Daratumumab and Dexamethasone (XDd) for the Treatment of Patients With Advanced Light-Chain Cardiac Amyloidosis: A Prospective, Multicenter, Phase II Clinical Study
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 2 study tests a three-drug regimen called XDd (selinexor + daratumumab + dexamethasone) in people with advanced light-chain cardiac amyloidosis. All participants receive the same treatment in a single treatment group and are followed for outcomes up to about 12 months. The study measures blood (hematologic) and organ responses, survival, quality of life, biomarkers, and safety.
What it is studying. The study is testing whether the XDd regimen (selinexor combined with daratumumab and dexamethasone) can achieve hematologic complete responses in patients with advanced light-chain cardiac amyloidosis and how the regimen affects cardiac and other organ responses, progression-free and overall survival, quality of life, biomarkers (dFLC, NT-proBNP, MRD), and safety.
What the researchers hope to learn. To measure hematologic complete response rate; cardiac and other organ response rates (heart, kidney, liver); duration and time to response; progression-free and overall survival; changes in quality of life (EORTC QLQ-C30); safety and adverse events; and biomarker changes (dFLC, NT-proBNP) and bone marrow minimal residual disease (MRD).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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?
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- XDd
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will receive the study drug combination (selinexor 40 mg by mouth once weekly; daratumumab given as subcutaneous injections—weekly in cycles 1–2, every 2 weeks in cycles 3–6, then every 4 weeks from cycle 7; and dexamethasone 20–40 mg once weekly). One treatment cycle is 4 weeks, and treatment assessments are planned for up to 12 months. You will have regular clinic visits for drug administration, safety checks, and blood tests about every 4 weeks (including measurements such as free light chains and NT-proBNP), plus quality-of-life questionnaires (EORTC QLQ-C30). Bone marrow sampling to assess minimal residual disease (MRD) is done at baseline and at end of treatment, and the study will record adverse events from the first dose through 28 days after the last dose.
How the study is structured. This is a Phase 2, interventional, open-label (no masking), single-group study. Everyone assigned to the study receives the XDd treatment as described in the registry; there is no randomization or placebo group. Treatment is delivered in 4-week cycles and key outcomes and biomarkers are assessed during treatment and up to about 12 months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Light-chain Cardiac Amyloidosis. Does it apply to my diagnosis?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
Important dates
- Study start
- Jul 13, 2026 (estimated)
- Primary completion
- Feb 1, 2028 (estimated)
- Study completion
- Jun 1, 2028 (estimated)
- Target enrollment
- 63 participants (estimated)
- Last updated on registry
- Aug 13, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Beijing Anzhen Hospital
- Principal investigator
- Yini Wang, Principal Investigator
Beijing Anzhen Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Yini Wang 📞 +86-010-84005477 ✉ wangyini@ccmu.edu.cn
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- complete response
- No sign of the condition can be found with the tests used in the study. It does not always mean the condition is gone permanently, and the definition depends on the condition and the study.
- progression-free survival
- The length of time during and after treatment that a person lives without the condition getting worse, as defined by the study.
- overall survival
- The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- free light chain
- Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- relapsed/refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- Difference between involved and uninvolved free light chains
- The difference between the abnormal ('involved') and normal ('uninvolved') free light chain levels in the blood. Used in some conditions to decide whether disease is measurable and to track response.
- women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- Written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- legal guardian
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- Baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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