Can a Triple-Drug combo tame a rare heart disease?
NCT ID NCT07743957
First seen Aug 04, 2026 · Last updated Aug 14, 2026 · Updated 3 times
Summary
This phase II trial is testing whether a combination of selinexor, daratumumab, and dexamethasone (called XDd) can help people with advanced light-chain cardiac amyloidosis, a condition where abnormal proteins build up in the heart. The study aims to see if the regimen can achieve a complete blood response and improve heart and organ function, as well as quality of life. Participants receive the drugs weekly or less often over several cycles, and the trial will track outcomes like survival and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of three drugs: selinexor (taken by mouth weekly), daratumumab (given as an injection under the skin), and dexamethasone (a steroid taken by mouth weekly).
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced light-chain cardiac amyloidosis, potentially improving blood and heart responses and extending survival.
- What could go wrong
- This is a phase II trial with a relatively small number of participants, so results may not be conclusive. The drugs can cause side effects, and the regimen may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 63 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years. * Confirmed systemic light-chain amyloidosis, meeting both of the following: 1. 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. 2. 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: 1. Mean ventricular wall thickness \> 12 mm on echocardiography, with other cardiac diseases excluded; or 2. 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: 1. Serum monoclonal protein ≥ 0.5 g/dL by serum protein electrophoresis and immunofixation performed by the central laboratory; 2. Serum free light chain ≥ 50 mg/L with an abnormal kappa/lambda ratio; or 3. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.