Ixazomib Maintenance for AL Amyloidosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the drug Ixazomib to determine its effectiveness in controlling AL Amyloidosis, a condition characterized by the buildup of abnormal proteins in organs and tissues. The goal is to assess whether Ixazomib can prevent or delay the recurrence of the disease. Participants will receive Ixazomib along with Dexamethasone, if tolerated. The trial seeks individuals diagnosed with AL Amyloidosis who have undergone initial treatment and have at least one organ affected by the condition. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take certain medications like strong CYP3A inducers (e.g., rifampin, carbamazepine) or St. John's wort within 14 days before starting the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that ixazomib, when combined with dexamethasone, is generally well-tolerated by patients with AL amyloidosis. In earlier studies, about 63% of patients taking this combination improved their condition. These studies also aimed to find the safest dose, and results suggest that most patients can handle the treatment well.
Although ixazomib is not yet specifically approved for AL amyloidosis, it has been studied in different contexts to better understand its safety. Patients in these studies experienced some side effects, but they were mostly mild and manageable. These findings provide some reassurance about the treatment's safety, but discussing any concerns with a doctor remains important.12345Why are researchers excited about this possible treatment for AL Amyloidosis?
Researchers are excited about ixazomib for AL amyloidosis because it offers a new mechanism of action compared to the current standard treatments, which typically include chemotherapy and stem cell transplantation. Ixazomib is a proteasome inhibitor, which means it works by blocking the protein complexes that break down unneeded proteins in cells, potentially reducing the buildup of amyloid. This oral medication also provides a more convenient administration compared to the intravenous delivery of many traditional options. Additionally, its targeted approach may lead to fewer side effects and improved safety, making it a promising option for patients who may not tolerate existing treatments well.
What evidence suggests that Ixazomib might be an effective treatment for AL Amyloidosis?
Research has shown that ixazomib, which participants in this trial will receive, may help treat AL Amyloidosis. One study found that 63% of patients with newly diagnosed AL Amyloidosis had a positive blood response when treated with a combination that included ixazomib. Another study examined patients whose disease returned after treatment and found that ixazomib helped 52% achieve a positive blood response, with 56% experiencing improvements in organ function. On average, the disease took 14.8 months to worsen. After one year, 60% of patients showed no disease progression, and 85% remained alive. These results suggest that ixazomib could effectively manage the disease and slow its progression.12678
Who Is on the Research Team?
Heather Landau, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with AL Amyloidosis who've had a partial response to initial therapy, have organ involvement, and are within 12 months of starting treatment. They must not have severe neuropathy or active infections, be pregnant or breastfeeding, or have other recent cancers. Men and women must follow specific contraception guidelines.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ixazomib at a fixed dose of 4mg on days 1, 8, and 15 of a 28-day cycle, with optional dexamethasone if tolerated, for up to 24 cycles or until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Ixazomib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Vanderbilt University Medical Center
Collaborator
Tufts Medical Center
Collaborator