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CARTITUDE-5 Trial Summary
This trial is testing if a new treatment for multiple myeloma is better than the current standard of care.
- Multiple Myeloma
CARTITUDE-5 Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
CARTITUDE-5 Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
CARTITUDE-5 Trial Design
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Who is running the clinical trial?
- You have hepatitis B.You are currently receiving treatment targeting B-cell maturation antigen (BCMA).You have been diagnosed with multiple myeloma based on specific guidelines from the International Myeloma Working Group.You have to be in good physical shape with no major limitations in your daily activities.You have moderate or severe peripheral neuropathy or nerve pain.You have a current or past history of involvement of the central nervous system or show signs of meningeal involvement in multiple myeloma.You have had a stroke or seizure in the last 6 months.Your test results need to meet certain criteria during the screening process.Your blood tests must show: hemoglobin levels at least 8.0 g/dL, platelet count at least 75 *10^9/L, lymphocyte count at least 0.3 *10^9/L, neutrophil count at least 1.0 *10^9/L, AST and ALT levels less than or equal to 3.0 times the upper limit of normal, and a kidney function test result showing a rate of at least 40 mL/min/1.73 m^2.You have a score of 2 or higher on the Myeloma Geriatric Assessment, which measures how frail or weak you are.You are not eligible for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) because of your age or other health conditions that may make it difficult for you to tolerate the treatment.You have been diagnosed with multiple myeloma based on specific criteria from a group of experts.You have tested positive for HIV.You have received a live, weakened vaccine within 4 weeks before starting the VRd treatment.You have hepatitis C.You have had CAR-T therapy before for any condition.You have detectable levels of specific proteins in your blood or urine that indicate the presence of the disease.You are not eligible for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) for specific reasons.You have a certain amount of abnormal proteins in your blood or urine that can be measured.You are in good enough health to perform daily activities without help.
- Group 1: Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)
- Group 2: Arm A: VRd+Rd (Standard Therapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Could you please share any other studies that have included Cilta-cel as a treatment?
"Cilta-cel was first studied in 1997 and, as of now, 2703 clinical trials have been completed. There are 1561 active studies currently, many of which are based in Orlando and Alberta."
What are the primary functions of Cilta-cel?
"Cilta-cel is an effective medication for synovitis. Additionally, it has been shown to help patients with ophthalmia, sympathetic, at least two prior systemic chemotherapy regimens, and lung cancers."
Are there any dangers that have been linked with Cilta-cel treatments?
"Cilta-cel falls into the third phase of clinical trials, which is why our team believes that it is safe. There is some data supporting efficacy and multiple rounds of data supporting safety."
Are there available positions for volunteers in this experiment?
"The most recent information on clinicaltrials.gov indicates that this study is still recruiting patients. It was first posted on August 19th, 2021 and was last edited on November 3rd, 2020. They are looking for 650 individuals total from 27 different sites."
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