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Light-chain Cardiac AmyloidosisPhase 2NCT07743957

Selinexor, Daratumumab, and Dexamethasone (XDd) for Light-Chain Cardiac Amyloidosis

A Phase 2 study testing XDd in people with Light-chain Cardiac Amyloidosis, run by Beijing Anzhen Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Light-chain Cardiac Amyloidosis
What is being tested?
XDd
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
No sites listed yet
Study dates
13 Jul 2026to 1 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yini Wang contact

+86-010-84005477

wangyini@ccmu.edu.cn

About this study

Official title: 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

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?

Being tested
XDd

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XDdDrug

    Selinexor (X): 40 mg orally once weekly (QW) Daratumumab (D): 1800 mg per dose, subcutaneous injection; administered once weekly during cycles 1-2, once every 2 weeks during cycles 3-6, and once every 4 weeks from cycle 7 onward. One cycle is 4 weeks.

    Dexamethasone (d): 20-40 mg once weekly (QW)

Study groups in NCT07743957
Study groupRoleWhat they receive
XDdExperimentalNot described
Receives: Drug: XDd

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hematologic complete response rate

    Measured: From enrollment to the end of treatment at 1 year

Secondary outcomes (11)

  1. Cardiac organ response rate

    Measured: From enrollment to the end of treatment at 1 year

  2. Organ response rate (heart, kidney, and liver)

    Measured: From enrollment to the end of treatment at 1 year

  3. Duration of response

    Measured: From first documented response until documented progression or death, assessed up to 1 years.

  4. Time to response

    Measured: From first dose until first documented response, assessed up to 1 years

  5. Progression-free survival

    Measured: From first dose until date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.

  6. Overall survival

    Measured: From first dose until date of death from any cause, assessed up to 12 months.

  7. Quality of life assessed by EORTC QLQ-C30

    Mean change from baseline in EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global health status/Quality of life score (range 0-100; higher scores indicate better quality of life)

    Measured: Through study completion, up to 1 year.

  8. Incidence and Severity of Adverse Events

    Measured: From the first dose through 28 days after the last dose

  9. Biomarker Outcome: dFLC

    Change from baseline in difference between involved and uninvolved free light chains (dFLC) (mg/L).

    Measured: Baseline and every 4 weeks during treatment, up to 12 months.

  10. Biomarker outcome: NT-proBNP

    Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) (pg/mL)

    Measured: Baseline and every 4 weeks during treatment, up to 12 months.

  11. Biomarker outcome: MRD

    Minimal residual disease (MRD) status in bone marrow (assessed by multiparameter flow cytometry of bone marrow).

    Measured: Baseline and at end of treatment, up to 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study start13 Jul 2026 (estimated)
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07743957
Sponsor's protocol ID
XDd-LCA-Phase2
Status last verified
Aug 2026
First submitted
13 Jul 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Morikawa K, Izumiya Y, Takashio S, Kawano Y, Oguni T, Kuyama N, Oike F, Yamamoto M, Tabata N, Ishii M, Hanatani S, Hoshiyama T, Kanazawa H, Matsuzawa Y, Usuku H, Yamamoto E, Ueda M, Tsujita K. Early experience with daratumumab-containing regimens in patients with light-chain cardiac amyloidosis. J Cardiol. 2025 Jun;85(6):440-446. doi: 10.1016/j.jjcc.2024.11.003. Epub 2024 Dec 4.

    PubMed 39577830

  • Gregory Kaufman, Ronald Witteles, Matthew Wheeler, Patricia Ulloa, Marie Lugtu, Sally Arai, Stanley Schrier, Richard Lafayette, Michaela Liedtke; Hematologic Responses and Cardiac Organ Improvement in Patients with Heavily Pretreated Cardiac Immunoglobulin Light Chain (AL) Amyloidosis Receiving Daratumumab. Blood 2016; 128 (22): 4525.

  • 戈程, 李佳月, 刘博罕, 等. 心肌淀粉样变性临床特点及远期预后的影响因素[J]. 中华老年多器官疾病杂志, 2020, 19(6):405-409.

  • Huang XH, Liu ZH. The Clinical Presentation and Management of Systemic Light-Chain Amyloidosis in China. Kidney Dis (Basel). 2016 Apr;2(1):1-9. doi: 10.1159/000444287. Epub 2016 Feb 25.

    PubMed 27536686

  • Nienhuis HL, Bijzet J, Hazenberg BP. The Prevalence and Management of Systemic Amyloidosis in Western Countries. Kidney Dis (Basel). 2016 Apr;2(1):10-9. doi: 10.1159/000444206. Epub 2016 Feb 25.

    PubMed 27536687

  • 中国系统性轻链型淀粉样变性协作组, 国家肾脏疾病临床医学研究中心, 国家血液系统疾病临床医学研究中心. 系统性轻链型淀粉样变性诊断和治疗指南（2021年修订） [J] . 中华医学杂志, 2021, 101(22) : 1646-1656.

  • Hou JH, Zhu HX, Zhou ML, Le WB, Zeng CH, Liang SS, Xu F, Liang DD, Shao SJ, Liu Y, Liu ZH. Changes in the Spectrum of Kidney Diseases: An Analysis of 40,759 Biopsy-Proven Cases from 2003 to 2014 in China. Kidney Dis (Basel). 2018 Feb;4(1):10-19. doi: 10.1159/000484717. Epub 2017 Dec 8.

    PubMed 29594138

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XDd in people with Light-chain Cardiac Amyloidosis, run by Beijing Anzhen Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yini Wang (+86-010-84005477, wangyini@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematologic complete response rate (time frame: From enrollment to the end of treatment at 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07743957, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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