Ixazomib Maintenance Study in Patients With AL Amyloidosis

  • STATUS
    Recruiting
  • End date
    Aug 26, 2023
  • participants needed
    47
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 26 March 2022
platelet count
vasectomy
corticosteroids
stem cell transplantation
measurable disease
leukemia
bone marrow procedure
dexamethasone
neutrophil count
chemotherapy regimen
congo red
amyloid deposition
alkylating agent
nervous

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.

Details
Condition AL Amyloidosis
Treatment Dexamethasone, Ixazomib
Clinical Study IdentifierNCT03618537
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

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
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)
At least a hematologic partial response (PR) defined by the updated AL response
Patients must have >10% bone marrow plasma cells (on aspirate or biopsy) at initial diagnosis
criteria (Pallidini et al. JCO 2012) to one line of initial therapy (may
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
include induction followed by autologous stem cell transplant (ASCT))
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
Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree
Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, OR
to one of the following
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
Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment
Absolute neutrophil count (ANC) ≥ 1,000/mm^3
Platelet count ≥ 75,000/mm^3
Hemoglobin ≥ 8.0 g/dL
ALT/AST < 2.5x the upper limit of normal
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)

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
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
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