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Could a maintenance drug keep AL amyloidosis at bay?

NCT ID NCT03618537

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing whether the oral chemotherapy drug ixazomib can help control AL amyloidosis after initial treatment. Seventeen adults with the disease will take ixazomib along with low-dose dexamethasone to see if it delays organ progression or the need for more therapy. The goal is to prevent or postpone relapse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ixazomib (a chemotherapy drug taken orally)
What this could lead to
If successful, this could help keep AL amyloidosis in remission longer and delay the need for further treatment.
What could go wrong
This is a small, early-phase study with only 17 participants, so results may not apply widely. The drug may cause side effects or fail to prevent relapse.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

17 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patients 18 years or older. 2. 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). 3. 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)). 4. Patients must have \>10% bone marrow plasma cells (on aspirate or biopsy) at initial diagnosis. 5. 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. 6. Patients must be within 12 months of the start of initial therapy. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. 8. 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 9. 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.) 10. 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 Exclusion Criteria: 1. Female patients who are lactating or have a positive serum pregnancy test during the screening period. 2. Patients with primary refractory AL amyloidosis (\< PR to initial therapy). 3. Patients resistant and/or refractory to proteosome inhibitors. 4. Active multiple myeloma with end organ damage (CRAB criteria). 5. 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. 6. 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). 7. Any serious medical or psychiatric illness that could, in the investigator"s opinion, potentially interfere with the completion of treatment according to this protocol. 8. 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. 9. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent. 10. Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing. 11. 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. 12. Patient has \> Grade 2 peripheral neuropathy, or Grade 1 with pain (not controlled with medical therapy) on clinical examination during the screening period. 13. 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.

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Conditions

The condition(s) this trial relates to.

AL amyloidosis Immunoglobulin Light-chain Amyloidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.