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AL AmyloidosisPhase 2NCT03618537

Ixazomib Maintenance Study in Patients With AL Amyloidosis

A Phase 2 study testing Ixazomib and Dexamethasone in people with AL Amyloidosis, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to learn if Ixazomib maintenance treatment (chemotherapy) works to control the disease. Through this study, the investigators hope to learn more about ways to prevent or delay relapse of AL Amyloidosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AL Amyloidosis
What is being tested?
Ixazomib and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
8 sitesUnited States
Study dates
2 Aug 2018to Aug 2026
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

  • Male or female patients 18 years or older.
  • Biopsy-proven diagnosis of AL amyloidosis at the enrolling institution, according to the following standard criteria:
  • Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence
  • If clinical and laboratory parameters insufficient to establish AL amyloidosis or in cases of doubt, amyloid typing may be necessary
  • Measurable disease as defined by serum differential free light chain concentration (dFLC, difference between amyloid forming [involved] and non amyloid forming [uninvolved] free light chain [FLC]) ≥ 50 mg/L) (or M-protein of 0.5g/dl) prior to initial therapy.
  • At least one organ involved with AL amyloidosis including renal, cardiac, GI/Liver, peripheral/autonomic nervous system and/or soft tissue disease (Comenzo et al. Leukemia 2012).
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  • At least a hematologic partial response (PR) defined by the updated AL response criteria (Pallidini et al. JCO 2012) to one line of initial therapy (may include induction followed by autologous stem cell transplant (ASCT)).
  • Patients must have >10% bone marrow plasma cells (on aspirate or biopsy) at initial diagnosis.
  • At least 2 cycles of any induction therapy (that may include alkylators, corticosteroids, proteosome inhibitors, IMIDs - including in combination) or upfront ASCT (with or without preceding induction). Patients who receive ixazomib as part of initial therapy are eligible.
  • Patients must be within 12 months of the start of initial therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
  • Female patients who:
  • Are postmenopausal for at least 1 year before the screening visit, OR
  • Are surgically sterile, OR
  • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug, AND
  • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
  • Have a negative serum pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
  • Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:
  • Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
  • Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
  • Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
  • Patients must meet the following clinical laboratory criteria:
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment.
  • Total bilirubin ≤ 2 x the upper limit of the normal range (ULN) (except in patients with Gilbert"s syndrome who must have a total bilirubin of < 3 x ULN).
  • ALT/AST < 2.5x the upper limit of normal

Who cannot join

  • Female patients who are lactating or have a positive serum pregnancy test during the screening period.
  • Patients with primary refractory AL amyloidosis (< PR to initial therapy).
  • Patients resistant and/or refractory to proteosome inhibitors.
  • Active multiple myeloma with end organ damage (CRAB criteria).
  • Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure (NYHA class III/IV), unstable angina, or myocardial infarction within the past 6 months.
  • Active systemic infection, including active hepatitis B or C virus infection. Patients who are human immunodeficiency virus (HIV) infected can be enrolled as long as CD4 is above 350, viral load has been undetectable for more than 6 months on stable anti-retroviral therapy, no previous AIDS-defining illness, and there is agreement with the HIV-treating physician that the patients can be monitored for possible treatment failure. Eligibility will be confirmed by the MSK Principal Investigator (PI).
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  • Any serious medical or psychiatric illness that could, in the investigator"s opinion, potentially interfere with the completion of treatment according to this protocol.
  • Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John"s wort.
  • Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
  • Diagnosed or treated for another malignancy within 2 years before study enrollment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with early stage prostate cancer, non melanoma skin cancer or carcinoma in situ of any type are not excluded; patients with malignancies that have undergone complete resection are not excluded.
  • Patient has > Grade 2 peripheral neuropathy, or Grade 1 with pain (not controlled with medical therapy) on clinical examination during the screening period.
  • Participation in other clinical trials, including those with other investigational agents not included in this trial, within 21 days of the start of this trial and throughout the duration of this trial.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: Ixazomib Maintenance Following Initial Therapy in Patients With Immunoglobulin Light Chain (AL) Amyloidosis

The purpose of this study is to learn if Ixazomib maintenance treatment (chemotherapy) works to control the disease. Through this study, the investigators hope to learn more about ways to prevent or delay relapse of AL Amyloidosis.

Conditions
AL Amyloidosis
Being tested
Ixazomib, Dexamethasone
Keywords
Ixazomib, 18-069
Medical subject headings
Immunoglobulin Light-chain Amyloidosis

What participants receive

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

  • IxazomibDrug

    Ixazomib at a fixed dose of 4mg on days 1, 8, and 15 of a 28-day cycle. Ixazomib will be given orally on days 1, 8, and 15 of a 28 day cycle.

  • DexamethasoneDrug

    Dexamethasone 4mg-12mg will be allowed on days 1, 8, 15 if patients previously tolerated dexamethasone without issue.

Study groups in NCT03618537
Study groupRoleWhat they receive
ixazomibExperimentalEnrolled patients will receive ixazomib at a fixed dose of 4mg on days 1, 8, and 15 of a 28-day cycle. Ixazomib will be given orally on days 1, 8, and 15 of a 28 day cycle. Dexamethasone 4mg-12mg will be allowed on days 1, 8, 15 if patients previously tolerated dexamethasone without issue. Treatment cycles will be repeated until disease progression for up to 24 cycles or until development of significant treatment-related toxicities.
Receives: Drug: Ixazomib; Drug: Dexamethasone

What is being measured

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

  1. event free survival (EFS)

    (EFS includes organ progression, next antiplasma cell directed therapy or death)

    Measured: 2 years

Timeline

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

  1. First posted7 Aug 2018
  2. Study start2 Aug 2018
  3. Primary completionAug 2026 (estimated)
  4. Study completionAug 2026 (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
Model description
This is a Phase II open-label study.
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03618537
Sponsor's protocol ID
18-069
Status last verified
Dec 2025
First submitted
2 Aug 2018
Last updated
4 Dec 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ixazomib and Dexamethasone in people with AL Amyloidosis, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

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 29 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 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?

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?

event free survival (EFS) (time frame: 2 years). 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 NCT03618537.

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 4 Dec 2025.

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