CAR-T Therapy for Multiple Myeloma
(CARTITUDE-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a treatment called JNJ-68284528. It aims to help patients who still have small amounts of cancer cells after their initial treatment. The treatment works by finding and killing these leftover cancer cells to prevent the disease from coming back.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less, which might imply adjustments to your current treatment. It's best to discuss your specific medications with the trial coordinators.
Is CAR-T therapy (cilta-cel) safe for humans?
Cilta-cel, a CAR-T therapy for multiple myeloma, has shown a generally tolerable safety profile, with most side effects being manageable. Common side effects include cytokine release syndrome (a reaction that can cause fever and low blood pressure) and other adverse events, but serious neurotoxicity was not reported in the studies.12345
How is the treatment JNJ-68284528 (Carvykti) different from other treatments for multiple myeloma?
JNJ-68284528 (Carvykti) is a unique treatment for multiple myeloma because it uses CAR-T cell therapy, where a patient's own T cells are modified to target and kill cancer cells. This approach is different from traditional treatments like chemotherapy or stem cell transplants, as it specifically targets the B cell maturation antigen (BCMA) on myeloma cells, offering a promising option for patients with relapsed or refractory multiple myeloma.678910
What data supports the effectiveness of the treatment Carvykti (cilta-cel) for multiple myeloma?
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for multiple myeloma patients with varying treatment histories. Some must have tried specific therapies and be refractory to lenalidomide, while others may be newly diagnosed or ineligible for certain treatments due to age or comorbidities. Participants need a measurable level of disease and should be in good physical condition (ECOG grade 0-1).Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion
Participants undergo lymphodepletion prior to receiving JNJ-68284528 infusion
Treatment
Participants receive a single infusion of JNJ-68284528, with some cohorts receiving additional treatments such as lenalidomide
Follow-up
Participants are monitored for safety, effectiveness, and MRD status after treatment
Open-label extension (optional)
Participants may continue to be monitored or receive additional treatment based on their response and MRD status
What Are the Treatments Tested in This Trial?
Interventions
- JNJ-68284528
JNJ-68284528 is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University