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Venetoclax + Ixazomib + Dexamethasone for AL Amyloidosis
Study Summary
This trial is testing a combination of drugs to treat light chain amyloidosis that has come back or does not respond to treatment. The drugs are venetoclax, ixazomib citrate, and dexamethasone.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 389 Patients • NCT02005471Trial Design
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Who is running the clinical trial?
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- My heart condition is severe, classified as NYHA III/IV or I have advanced cardiac amyloidosis.I have recovered from side effects of previous cancer treatments, except for hair loss.I have no stomach or intestine problems that affect how I absorb pills.I am 18 years old or older.My AL amyloidosis shows through specific blood or urine tests.My white blood cell count is healthy without needing medication for at least 1-2 weeks.I am not taking any strong or moderate drugs that affect enzyme activity.I need treatment after trying at least one other therapy.My cancer has spread to my brain or spinal cord.I don't have bone lesions or organ damage from multiple myeloma.My bone marrow biopsy shows I have the t(11;14) genetic marker.I have severe diarrhea.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I can take care of myself but might not be able to do heavy physical work.I have another cancer type, but it won't affect this trial's treatment.I am not pregnant or breastfeeding while considering treatment with MLN9708.My AL amyloidosis is at a cardiac risk stage of I, II, or IIIa.Your platelet count should be at least 75,000 per microliter of blood, and you shouldn't have received a platelet transfusion within 2 weeks before joining the study.I have not had major surgery or radiotherapy within the last 14 days.I am aware that my medication needs to be taken carefully with certain other drugs.I am allergic to venetoclax, ixazomib, or dexamethasone.My condition is confirmed AL amyloidosis needing treatment.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I haven't had specific cancer treatments in the last 4 to 6 weeks.You are expected to live for at least 3 more months.Your liver enzyme levels are not more than three times the normal limit.The amount of plasma cells in your blood is less than or equal to 60%.Your heart's pumping ability is at least 35% according to an echocardiogram.I had hepatitis C but have been treated and cured.Your white blood cell count is at least 3,000 per microliter.My kidneys work well enough, with a clearance rate of at least 15 mL/min.I do not have any serious ongoing illnesses or recent heart issues.I have severe nerve pain or numbness.I have been treated with MLN9708 or venetoclax before.You don't have specific markers in your blood or urine that can be used to measure your disease.My hepatitis B virus load is undetectable with treatment.Your total bilirubin level should be within a certain range based on the normal levels at the medical facility where you are receiving treatment.
- Group 1: Treatment (venetoclax, ixazomib citrate, dexamethasone)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How is Venetoclax usually prescribed for therapeutic purposes?
"Venetoclax is frequently prescribed to treat ophthalmia and sympathetic eye disorders. It has also been known to be beneficial in treating branch retinal vein occlusion and macular edema."
Are there any open recruitment opportunities for this experiment?
"Affirmative. According to clinicaltrials.gov, this medical trial commenced recruitment on September 14th 2021 and is still in need of participants as of November 18th 2022. 6 people are required for the experiment across 10 different sites."
What is the current size of the cohort participating in this research?
"This study requires the recruitment of 6 suitable candidates. These individuals can join from Montefiore Medical Center-Einstein Campus in Bronx, New york or Montefiore Medical Center-Weiler Hospital in Charlottesville, Virginia."
How many locations are participating in conducting this trial?
"Currently, 10 different medical facilities are enrolling participants. These sites span from Bronx to Baltimore and everywhere in between; therefore it is advisable to select the one that requires minimal travel for your own convenience."
What other investigations with Venetoclax have been initiated?
"Venetoclax was initially studied in 2002 by Manitoba Blood & Marrow Transplant Program CancerCare Manitoba and 1184 trials have been successfully concluded. Presently, 778 studies are active with a considerable portion originating from Bronx, New york."
What adverse effects has Venetoclax been known to cause in patients?
"Due to the limited data on Venetoclax's efficacy and safety, a score of 1 was assigned by Power professionals. This is in keeping with its Phase 1 trial status."
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