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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03618537
Other study ID # 18-069
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date August 2, 2018
Est. completion date August 2026

Study information

Verified date November 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 17
Est. completion date August 2026
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Tufts Medical Center Boston Massachusetts
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (3)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Tufts Medical Center, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary event free survival (EFS) (EFS includes organ progression, next antiplasma cell directed therapy or death) 2 years
See also
  Status Clinical Trial Phase
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Completed NCT02574676 - Quality of Life (QOL) Registry for Patients With AL Amyloidosis
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Active, not recruiting NCT05199337 - Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis Phase 1/Phase 2
Recruiting NCT01758042 - Bone Marrow and Kidney Transplant for Patients With Chronic Kidney Disease and Blood Disorders N/A
Completed NCT01409148 - Radioimmunoimaging of AL Amyloidosis Phase 1
Active, not recruiting NCT04512235 - A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis Phase 3
Not yet recruiting NCT06022939 - Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis Phase 3
Recruiting NCT06383143 - Promoting Diagnosis and Management of AL in Italy (ProDigALIty)
Recruiting NCT05277493 - A Registry of Chinese AL Amyloidosis Patients Treated With Subcutaneous or Intravenous Daratumumab
Completed NCT02632786 - The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Phase 2
Completed NCT02841033 - Daratumumab for the Treatment of Patients With AL Amyloidosis Phase 1/Phase 2
Completed NCT04304144 - A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis Phase 2
Recruiting NCT01408225 - Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
Recruiting NCT04895917 - Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis Phase 2
Terminated NCT02489500 - Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib Phase 3
Completed NCT01570387 - A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis Phase 1/Phase 2
Terminated NCT03154047 - Study in Subjects With Light Chain (AL) Amyloidosis Phase 2
Completed NCT03236792 - Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis Phase 1/Phase 2
Recruiting NCT04392960 - Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL Amyloidosis N/A