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Amyloidosis CardiacPhase 3NCT04298372

Frontline Lenalidomide for AL Amyloidosis Involving Myocardium

A Phase 3 study testing Lenalidomide 25mg in people with Amyloidosis Cardiac, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II clinical trial aimed at influencing the improvement of major organ functions, especially the objective response rate, in Amyloid light-chain amyloidosis involving myocardium. Read more about this study

Who is it for?
Ages 19 to 99 years
Conditions the study is for
Amyloidosis Cardiac
What is being tested?
Lenalidomide 25mg
How many people
2 participants
Where
1 siteSouth Korea
Study dates
20 Feb 2019to 25 Nov 2021
Phase
Phase 3
Are there results?
None posted in the registry

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 19 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age more than 19 years old
  • Amyloid light-chain amyloidosis patients who meet both(A and B) of the following criteria
  • Cardiac involvement: meet one or more of the following criteria
  • Echocardiography : mean wall thickness > 12mm, and no other cardiac cause
  • Cardiac MRI : CMR was considered positive for amyloid cardiomyopathy if there were morphologic and structural abnormalities consistent with the diagnosis (wall thickening of the left ventricular [LV], right ventricular [RV], or interatrial septum and biatrial enlargement) coupled with abnormal myocardial nulling and diffuse or irregular delayed gadolinium enhancement of the LV myocardium.
  • N-terminal prohormone of brain natriuretic peptide : > 332ng/l in the absence pf renal failure
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  • Exposure history to lenalidomide: participants should have never been exposed to lenalidomide within 5 years.
  • Eastern Cooperative Oncology Group performance status ≤ 3
  • Patients must meet the following clinical laboratory criteria with 2 weeks of starting treatment:
  • Serum creatinine ≤ 3.0mg/dl or Creatinine Clearance ≥ 50ml/minute (Cockcroft-Gault)
  • Absolute neutrophil count ≥ 1000/ul
  • Platelet ≥ 75,000/ul
  • Hemoglobin ≥ 8.0mg/dl
  • Bilirubin < 2 times or Alkaline phosphate < 4 times upper limit of normal
  • At least 3 months of existence are expected from the time of enroll this study
  • A female of childbearing potential(is defined as a sexually mature woman who: 1 has not undergone a hysterectomy or bilateral oophorectomy or 2, has not been naturally post-menopausal (amenorrhea following cancer therapy does not rule out childbearing potential) must have a negative pregnancy test prior to treatment.
  • must agree to use two reliable methods of contraception simultaneously or practice complete abstinence from any heterosexual intercourse during the following time periods related to this study: for at least 4 weeks after study treatment discontinuation.
  • must have two(serum and urine) negative pregnancy test during screening period
  • must have serum and urine negative pregnancy test within 10-14 days and 24hrs before commencing lenalidomide
  • Male patients who agree to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study treatment
  • Patients who understand and voluntarily agree to the contents of the research statement in writing and who are willing and able to comply with the visit schedule, treatment plan, laboratory examination and other testing procedures

Who cannot join

  • Amyloid light-chain amyloidosis without cardiac involvement
  • Patients who are planning to receive autologous stem cell transplantation or received autologous stem cell transplantation, remained in hematologic complete response
  • Pregnant, lactating or unwilling to use adequate contraception
  • Male patients who unwilling to practice effective barrier contraception during the entire study treatment period and through 30 days after the last dose of study treatment
  • Patients with acute infections requiring nonpermanent therapy (antibiotics, antibacterial drugs, or antiviral drugs) within 14 days of the first administration of the lenalidomide or with a history of systemic fungal infections and infections without valid antimicrobial agents
  • Any clinically significant history of genetic, kidney, neurological, psychiatric, endocrine, metabolism, immunological, cardiovascular, lung, or liver diseases in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent.
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  • Patients with known history of allergic and hypersensitivity for investigational product, their analogous bodies, or the subtypes contained in the various forms of any preparation
  • Patients who were given a live vaccine within 8 weeks of the first dose of the drug
  • Chemotherapy with approved or investigation anticancer therapeutics within 4 weeks prior to starting this study
  • Patients who are unable to voluntarily agree to participate in a study or who are not willing to participate

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: Frontline Lenalidomide for AL Amyloidosis Involving Myocardium: Investigation of Organ Reversing Capacity of Lenalidomide

This phase II clinical trial aimed at influencing the improvement of major organ functions, especially the objective response rate, in Amyloid light-chain amyloidosis involving myocardium.

Read the detailed description

This study was designed according to the 18F-florbetaben positron emission tomography imaging, which successfully demonstrated a significant reduction in the amount of amyloid in the heart when administered by merging thalidomide and dexamethasone in patients involving myocardium, and reported that this reaction leads to an improvement in cardiac function. Amyloid light-chain amyloidosis patients at age 19 or older with refractory or relapsed who participants should have never been exposed to lenalidomide within 5 years. Planned initial dosage of the current regimen are as follow;

  • Lenalidomide : D1~D21 daily oral administration, starting dose 15mg, with an increase of 5mg every cycle, if tolerated, up to 25mg.
  • Dexamethasone : D1~D4 daily oral administration or intravenous injection, 40mg(or 20mg for age for age ≥ 65 years old) Patients will be treated every 4 weeks as one cycle, and up to 12 cycles of treatment will be conducted. The investigator is working on a total of 30 patients, the primary endpoint of this study is objective response rate and secondary endpoints are cardiac/renal/hepatic function, 18F-florbetaben positron emission tomography imaging parameter, overall survival period, progression-free survival period, toxicity profile.
Being tested
Lenalidomide 25mg
Medical subject headings
Amyloid Neuropathies, Familial

What participants receive

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

  • Lenalidomide 25mgDrug

    Also called Revlimid 25mg

    As single arm study, patients will be treated as follows:

    • Lenalidomide : D1~D21 daily oral administration, starting dose 15mg, with an increase of 5mg every cycle, if tolerated, up to 25mg.
    • Dexamethasone : D1~D4 daily oral administration or intravenous injection, 40mg(or 20mg for age for age ≥ 65 years old) Patients will be treated every 4 weeks as one cycle, and up to 12 cycles of treatment will be conducted.

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as the percentage of subjects with evidence of a confirmed CR(complete response), VGPR(very good partial response) or PR(partial response)

    Measured: After completion of 12 cycles of treatment(each cycle is 28 days)

Secondary outcomes (3)

  1. Change of the cardiac function

    Change of the cardiac function will be observed with the NTproBNP levels.

    Measured: At Baseline and the end of each 1-12 cycles (baseline and 1-12 months)

  2. Change of the renal function

    Change of the renal function will be observed with the 24h urine protein levels.

    Measured: At Baseline and the end of each 1-12 cycles (baseline and 1-12 months)

  3. Change of the hepatic function

    Change of the hepatic function will be observed with the alkaline phophatase levels.

    Measured: At Baseline and the end of each 1-12 cycles (baseline and 1-12 months)

Timeline

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

  1. First posted6 Mar 2020
  2. Study start20 Feb 2019
  3. Primary completion25 Nov 2021
  4. Study completion25 Nov 2021

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04298372
Sponsor's protocol ID
1810-089-981
Status last verified
Apr 2024
First submitted
3 Dec 2019
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenalidomide 25mg in people with Amyloidosis Cardiac, run by Seoul National University Hospital at 1 site in South Korea.

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 21 inclusion and 10 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: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: After completion of 12 cycles of treatment(each cycle is 28 days)). 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 NCT04298372.

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 17 Apr 2024.

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