Ixazomib Maintenance Study in Patients With AL Amyloidosis (NCT03618537) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ixazomib Maintenance Study in Patients With AL Amyloidosis
United States17 participantsStarted 2018-08-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female patients 18 years or older.
✓. Biopsy-proven diagnosis of AL amyloidosis at the enrolling institution, according to the following standard criteria:
✓. 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:
Exclusion criteria
✕. 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).
✕. 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.