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Ixazomib Maintenance for AL Amyloidosis
Phase 2
Waitlist Available
Led By Heather Landau, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease as defined by serum differential free light chain concentration (dFLC) ≥ 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if Ixazomib maintenance treatment can help control AL Amyloidosis and prevent or delay relapse.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if Ixazomib can control AL Amyloidosis after initial therapy success. It's given as maintenance chemotherapy to prevent disease relapse. Patients will also receive Dexamethasone as part of the treatment regimen.See study design
What are the potential side effects?
Ixazomib may cause side effects like gastrointestinal issues (nausea, vomiting), low blood counts leading to increased infection risk or bleeding problems, skin rash, fatigue, and potential nerve damage (neuropathy).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show significant markers for my disease.
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My AL amyloidosis affects at least one organ, like my kidneys, heart, or liver.
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I have completed at least 2 cycles of initial treatment or had a stem cell transplant.
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I am able to care for myself and perform daily activities.
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My blood cancer responded partially to my first treatment.
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My diagnosis of AL amyloidosis is confirmed by a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
event free survival (EFS)
Side effects data
From 2021 Phase 4 trial • 45 Patients • NCT0341637429%
Diarrhoea
24%
White blood cell count decreased
20%
Platelet count decreased
16%
Rash
16%
Neutrophil count decreased
11%
Pneumonia
9%
Constipation
9%
Malaise
9%
Pyrexia
9%
Anaemia
9%
Nasopharyngitis
7%
Decreased appetite
7%
Taste disorder
4%
Acute kidney injury
4%
Influenza
2%
Bile duct stone
2%
Gastroenteritis
2%
Pneumonia bacterial
2%
Bone pain
2%
Febrile neutropenia
2%
Duodenal ulcer
2%
Enterocolitis
2%
Tibia fracture
2%
Interstitial lung disease
2%
Prinzmetal angina
2%
Compression fracture
2%
Spinal compression fracture
2%
Tumour lysis syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
[Overall]; Combination Therapy + Ixazomib Therapy
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: ixazomibExperimental Treatment2 Interventions
Enrolled patients will receive 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 4mg-12mg will be allowed on days 1, 8, 15 if patients previously tolerated dexamethasone without issue. Treatment cycles will be repeated until disease progression for up to 24 cycles or until development of significant treatment-related toxicities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Ixazomib
2017
Completed Phase 4
~3370
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterOTHER
859 Previous Clinical Trials
672,350 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,937 Previous Clinical Trials
588,303 Total Patients Enrolled
1 Trials studying AL Amyloidosis
30 Patients Enrolled for AL Amyloidosis
Tufts Medical CenterOTHER
256 Previous Clinical Trials
255,720 Total Patients Enrolled
1 Trials studying AL Amyloidosis
3 Patients Enrolled for AL Amyloidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a stomach or intestine condition that could affect how I absorb pills.I am a woman following specific guidelines regarding menopause, birth control, and pregnancy tests.I am not pregnant or breastfeeding.My condition did not improve with proteasome inhibitor treatments.I have severe nerve pain in my hands or feet that isn't controlled by medicine.I do not have any active infections, including hepatitis B or C.I do not have any serious health or mental conditions that could stop me from completing treatment.I have not been diagnosed or treated for another cancer within the last 2 years.My blood tests show significant markers for my disease.My AL amyloidosis affects at least one organ, like my kidneys, heart, or liver.My multiple myeloma is causing damage to my organs.I have completed at least 2 cycles of initial treatment or had a stem cell transplant.You must have more than 10% of a specific type of cells in your bone marrow when first diagnosed.I have heart problems that are not well-managed.I am able to care for myself and perform daily activities.I haven't taken strong medication or St. John's wort in the last 14 days.Patients must have specific test results from their medical tests.I am following the required contraception guidelines.I started my initial cancer treatment less than a year ago.My condition is primary refractory AL amyloidosis.My blood cancer responded partially to my first treatment.My diagnosis of AL amyloidosis is confirmed by a biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: ixazomib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you enumerate the clinical trials that have utilized Ixazomib?
"A study of the drug ixazomib began at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba back in 2002. Since then, 1136 trials have been completed and 574 are being conducted presently; many of these studies taking place in New york City."
Answered by AI
What medical issues does Ixazomib typically target?
"Ixazomib can be prescribed to patients suffering from ophthalmia, sympathetic and other diseases of the eye like branch retinal vein occlusion or macular edema."
Answered by AI
Has the U.S. Federal Drug Administration granted approval for Ixazomib?
"Taking into consideration the limited amount of data regarding Ixazomib, our team at Power has determined a safety rating of 2. This is consistent with it being in phase 2 clinical trials and having no evidence for efficacy yet established."
Answered by AI
Is recruitment currently open for this research endeavor?
"Data hosted on clinicaltrials.gov indicates that this experiment is actively seeking participants, with the original post date being August 2nd 2018 and last edited on January 21st 2022."
Answered by AI
Is this study available to participants in North America at various research centers?
"8 medical sites are operating in the field of this clinical trial, including Memorial Sloan Kettering Cancer Center (New york), Memorial Sloan Kettering Nassau (Uniondale) and Tufts Medical Center (Boston). In addition to these locations, 5 other centres are involved."
Answered by AI
How many participants have enrolled in this clinical trial thus far?
"This trial needs 47 qualified patients to partake in it. Those who meet the eligibility requirements can sign up at either Memorial Sloan Kettering Cancer Center of New york, or their Nassau centre located in Uniondale."
Answered by AI
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