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CAR T-cell Therapy
Cilta-cel for Multiple Myeloma
Phase 2
Waitlist Available
Research Sponsored by Janssen Scientific Affairs, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial will study a possible new cancer treatment to see if it is safe and effective.
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Complete Response (CR) Rate
Duration of Response (DOR)
+14 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ciltacabtagene Autoleucel (Cilta-cel)Experimental Treatment2 Interventions
Eligible participants will receive bridging therapy (that is, anti-plasma cell directed treatment) based on participant's clinical status and timing of availability of cilta-cel (JNJ-68284528) along with lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square [mg/m^2] intravenous [IV] and fludarabine 30 mg/m^2 IV daily, for 3 days). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants will receive a single IV infusion of cilta-cel (JNJ-68284528) at a total targeted dose of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cilta-cel
2022
Completed Phase 2
~90
Lymphodepleting Therapy (Cyclophosphamide and Fludarabine)
2022
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
Janssen Scientific Affairs, LLCLead Sponsor
159 Previous Clinical Trials
580,432 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,010 Patients Enrolled for Multiple Myeloma
Janssen Scientific Affairs, LLC Clinical TrialStudy DirectorJanssen Scientific Affairs, LLC
36 Previous Clinical Trials
86,152 Total Patients Enrolled
2 Trials studying Multiple Myeloma
186 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have hepatitis B.You have an autoimmune disease that is not under control.Women who could become pregnant must have a negative pregnancy test before starting the medication.You are eligible to receive a specific type of chemotherapy that reduces the number of lymphocytes in your body.You are allergic to any of the ingredients in the cilta-cel treatment, such as dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin.You have a serious or life-threatening form of multiple myeloma, and additional specific treatments are not suitable for you as determined by the doctor.You have been infected with hepatitis C or have a history of hepatitis C.You have tested positive for HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Ciltacabtagene Autoleucel (Cilta-cel)
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.
Is the clinical trial for this medical experiment available in multiple areas of North America?
"This trial is enrolling participants at 24 locations, including San Francisco, Atlanta and Westwood. To reduce travel needs, patients should select the clinical site closest to them."
Answered by AI
How many participants are currently recruited for this research trial?
"Janssen Scientific Affairs, LLC is responsible for the recruitment of 330 eligible participants across two major sites: University of California San Francisco in California and Emory University located in Atlanta."
Answered by AI
What possible perils can patients experience when taking Cilta-cel?
"After careful consideration, our team at Power has decided to score Cilta-cel's safety a 2 as this is a Phase 2 trial and there exists evidence of its basic security but no data confirming efficacy."
Answered by AI
Is this clinical research still open to enrollment?
"Clinicaltrials.gov reveals that this investigation is presently searching for participants, having first been posted on May 13th 2022 and being revised as recently as December 1st 2021."
Answered by AI
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