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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 1 year
Awards & highlights
No Placebo-Only Group
Pivotal Trial
CARTITUDE-5 Trial Summary
This trial is testing if a new treatment for multiple myeloma is better than the current standard of care.
Eligible Conditions
- Multiple Myeloma
CARTITUDE-5 Trial Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with multiple myeloma based on specific guidelines from the International Myeloma Working Group.
Select...
You have to be in good physical shape with no major limitations in your daily activities.
Select...
Your test results need to meet certain criteria during the screening process.
Select...
You have detectable levels of specific proteins in your blood or urine that indicate the presence of the disease.
Select...
You are not eligible for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) for specific reasons.
CARTITUDE-5 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Arm B: Levels of Chimeric Antigen Receptor T cell (CAR-T) Cell Activation Markers
Arm B: Levels of Cilta-cel Expansion (proliferation), and Persistence
Arm B: Levels of Soluble B-cell Maturation Antigen (BCMA)
+17 moreAwards & Highlights
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.
CARTITUDE-5 Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)Experimental Treatment6 Interventions
Participants will receive VRd regimen for 6 cycles before randomization. Following randomization, participants in Arm B will undergo apheresis and receive two more cycles of VRd as bridging therapy. In VRd treatment, participants will receive bortezomib 1.3 mg/m^2 SC on Days 1, 4, 8 and 11 of each cycle for Cycles 1 to 8; oral lenalidomide 25 mg on days 1 to 14 of each cycle for Cycles 1 to 8 and oral dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle for Cycles 1 to 8. Each cycle will consist of 21 days. After 8 cycles of VRd, participants will receive a conditioning regimen (cyclophosphamide 300 mg/m^2 intravenous [IV] and fludarabine 30 mg/m^2 IV daily for 3 days) and Cilta-cel infusion 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells/kilogram (kg).
Group II: Arm A: VRd+Rd (Standard Therapy)Experimental Treatment3 Interventions
Participants will receive bortezomib, lenalidomide, and dexamethasone (VRd) regimen for 6 cycles before randomization. Following randomization, participants in Arm A will receive 2 more cycles of VRd. In VRd treatment, participants will receive bortezomib 1.3 milligram per meter square (mg/m^2) subcutaneously (SC) on Days 1, 4, 8 and 11 of each cycle (Cycles 1 to 8), oral lenalidomide 25 mg on Days 1 to 14 of each cycle (Cycles 1 to 8) and oral dexamethasone 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle (Cycles 1 to 8). Each cycle will consist of 21 days. After 8 cycles of VRd, treatment will continue with lenalidomide and dexamethasone (Rd) maintenance therapy. In Rd treatment, participants will receive oral lenalidomide 25 mg on Days 1 to 21 of each cycle and oral dexamethasone 40 mg on Days 1, 8, 15, and 22 of each cycle. Each cycle will consist of 28 days. Participants will continue to receive Rd until confirmed progressive disease or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1090
Cyclophosphamide
1995
Completed Phase 3
~3790
Lenalidomide
2005
Completed Phase 3
~1480
Bortezomib
2005
Completed Phase 2
~1140
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
961 Previous Clinical Trials
6,377,240 Total Patients Enrolled
68 Trials studying Multiple Myeloma
17,786 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
738 Previous Clinical Trials
3,957,774 Total Patients Enrolled
48 Trials studying Multiple Myeloma
12,810 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: VRd+Ciltacabtagene Autoleucel (Cilta-cel)
- Group 2: Arm A: VRd+Rd (Standard Therapy)
Awards:
This trial has 2 awards, including:- 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.
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 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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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