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Isatuximab for Primary Amyloidosis
Study Summary
This trial is studying how well a monoclonal antibody called isatuximab works in treating patients with primary amyloidosis that has come back or does not respond to treatment.
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 2023 Phase 3 trial • 307 Patients • NCT02990338Trial Design
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- Your heart's pumping ability, measured by echocardiogram, is at least 35%.Your doctor needs to confirm that you have a specific amount of disease and certain blood tests done before you can join the study.Your blood test results must show a significant difference between two types of proteins in your blood within 14 days before joining the study.I have hepatitis B with minimal liver damage and am on effective treatment, or I had hepatitis C, treated and cured, with minimal liver damage.I would be expected to live a normal lifespan if not for my relapsed/refractory amyloid condition.I have heart issues not caused by high blood pressure or heart valve disease.My cancer has spread to other organs, as confirmed by tests.I do not have active symptoms of multiple myeloma according to the IMWG criteria.My condition did not improve after at least one treatment like transplant, radiation, or chemotherapy.Your liver enzymes (SGOT/AST and SGPT/ALT) should not be more than 4 times the normal level in the 14 days before you join the study.I had a full medical check-up within the last 14 days.I have never had an AIDS-defining condition.I haven't had cancer in the last 5 years, except for skin cancer.I am not eligible for a stem cell transplant using my own cells.My recent tests show detailed bone marrow analysis results.My heart failure is not the most severe type.I do not have any serious health issues that are not under control.I haven't taken any supplements or drugs like doxycycline or curcumin in the last 14 days.My kidney function, measured by creatinine clearance, is adequate.My hemoglobin level is at least 8 g/dL, possibly after a recent transfusion.My blood pressure has been below 160/100 in the last 14 days.I have had a condition where my lymphocytes grow abnormally.I have a history of cancer.I finished my last cancer treatment or surgery more than 2 weeks ago, and any stem cell transplant over 100 days ago.I haven't taken daratumumab in the last 56 days and it was effective when I did.I have high levels of protein in my urine or a kidney biopsy showing amyloid deposits.I am not pregnant, can take a pregnancy test before each treatment, and will use birth control or abstain from sex.You have HIV, but if you meet all the other criteria, you can still participate in the study.My diabetes is under control with an HbA1C level below 7%.Your total bilirubin level needs to be less than 2 times the upper limit of normal within 14 days before joining the study.I am willing to follow my HIV treatment plan closely.My AL amyloidosis has returned or didn't respond to treatment, confirmed by specific tests.Your standard HIV test shows no sign of the virus in your blood.I am not allergic to isatuximab or similar antibody treatments.Your platelet count should be at least 75,000 cells per microliter within 14 days before joining the study.I can take care of myself but might not be able to do heavy physical work.Your NT-proBNP level needs to be less than or equal to 8500 ng/L within 14 days before you join the study.In the 14 days before signing up for the trial, your white blood cell count should be at least 1,000 cells/microliter without needing additional medication.
- Group 1: Treatment (isatuximab)
- 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
Has Isatuximab received regulatory authorization from the FDA?
"While Isatuximab has not yet been proven efficacious, there is supporting evidence for its safety which earned it a rating of 2."
Is there currently a recruitment process underway for this clinical trial?
"Currently, this trial is not enrolling any prospective participants. Initially posted on March 8th 2018 and last modified on August 22nd 2022; nevertheless, there are 716 active studies seeking patients with nausea and 46 trials admitting subjects to test Isatuximab."
Where are the various sites hosting this clinical trial?
"This clinical trial has 100 different sites, including United Hospital Center in Bridgeport, Marshfield Medical Center-EC Cancer Center in Eau Claire and Eastern Maine Medical Centre in Bangor. An array of other medical centres are also associated with this research project."
How many volunteers are eligible to join this clinical experiment?
"This experiment has reached its recruitment limit and is no longer taking on new participants. It was initially posted in March 8th 2018 and the most recent update occurred August 22nd 2022. If you are looking for other opportunities, currently 716 trials are enrolling patients with nausea and 46 studies require volunteers to investigate Isatuximab's efficacy."
Are there records of past experiments utilizing Isatuximab?
"Initially tested in 2010 at Investigational Site 604001, isatuximab has since been trialled 576 times. At present there are 46 active studies occurring within Bridgeport, West virginia with a plethora of these trials ongoing."
Is this investigation a pioneering endeavor?
"Since 2010, Isatuximab has been the subject of numerous clinical trials. Sanofi sponsored the first trial in that year; this study included 351 patients and paved the way for Phase 1 & 2 drug approval. Currently, there are 46 active investigations into Isatuximab's efficacy being conducted across 358 cities and 39 countries worldwide."
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