Your session is about to expire
← Back to Search
Isatuximab + Standard Therapy for Multiple Myeloma
Study Summary
This trial will test a new cancer drug given with two other drugs to see if it is safe and effective.
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
Find a Location
Who is running the clinical trial?
Media Library
- Your platelet count is at least 70 x 10^9/L (or at least 50 x 10^9/L if you have a lot of plasma cells in your bone marrow).Your corrected serum calcium level is less than or equal to 3.5 mmol/L.Your hemoglobin level is at least 80 grams per liter. If it's lower, you can still participate if you receive a blood transfusion.I plan to try for a child during or within 3 months after the study.Your heart's electrical activity, as measured by an ECG test, shows that it takes too long for your heart to recharge between beats (more than 470 milliseconds).I can take care of myself and am up and about more than half of my waking hours.I am not allergic to mannitol, steroids, monoclonal antibodies, their components, or mammal products.I have brain involvement, plasma cell leukemia, or amyloidosis.I am a woman capable of becoming pregnant.I agree to use two reliable birth control methods or abstain from sex for specific periods before and after the study.Your bilirubin levels should be within a certain range, unless you have Gilbert's disease.I have been recently diagnosed with symptomatic multiple myeloma.Your kidney function is good, with a measured glomerular filtration rate of 30 milliliters per minute or higher.I agree not to donate semen during and for 150 days after the study.I agree not to donate blood during and for 28 days after the study.I agree to use a condom during sexual activity for 150 days after the study ends.I agree not to breastfeed during the study and for 150 days after stopping the study drug.Your AST and ALT levels in your blood should be no more than 3 times the upper limit of normal.I do not have severe health issues like uncontrolled diabetes or infections that could risk my safety in the trial.I have been cancer-free from any cancer other than multiple myeloma for over 3 years.I have severe high blood pressure that is not well-controlled.I have HIV or active hepatitis B or C.I have only used corticosteroids for my Multiple Myeloma, not exceeding the specified dose.I have previously been treated with Isatuximab or a similar drug.I do not have any uncontrolled heart conditions.You are expected to live for at least 9 more months.You have a disease that can be measured using specific criteria.I am between 18 and 75 years old.Your ANC (absolute neutrophil count) is equal to or greater than 1.0 x 10^9 per liter.
- Group 1: Isatuximab with CyBorD and Lenalidomide Maintenance
- 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
Are patients still being recruited for this trial?
"Yes, this is an ongoing study that is currently seeking 65 subjects at 10 different clinical trial sites. The original posting was on December 8th, 2021 with the most recent update being February 14th, 2022."
How many people fit the eligibility criteria for this research project?
"The clinical trial is actively recruiting patients, with 65 participants needed from 10 locations. The trial was posted on December 8th, 2021 and last edited February 14th, 2022."
When was Isatuximab cleared by the FDA?
"Isatuximab's safety is estimated to be a 2 because, while there is data indicating it is safe, there is no current evidence that the medication is effective."
Where can patients enroll in this clinical trial?
"To limit the amount of travelling required for participants, this clinical trial is being conducted out of 10 locations. These include cities such as Saskatoon, Winnipeg and Toronto."
Share this study with friends
Copy Link
Messenger