A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma

UVA Tracking #
HSR230526
Principal Investigator
Laahn H Foster
Contact
Contact Phone
Official Trial Title
A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over who have recently been diagnosed with multiple myeloma and have not received prior therapy. The purpose of this study is to see if the study medication is safe and useful for treating patients with multiple myeloma. You will participate in either Cohort G or H of this study:

• Cohort G: Participants in this group are newly diagnosed with multiple myeloma without prior therapy and for whom autologous stem cell transplant (ASCT) is not planned. Participants in this group will be treated with four cycles of DRd which includes daratumumab subcutaneous (Dara-SC), lenalidomide and dexamethasone followed by study medication. You will receive the study medication via an IV infusion. After that, participants will attend study visits for a maximum of 2.5 years after the study medication.
• Cohort H: Participants in this group are newly diagnosed with multiple myeloma and are eligible for autologous stem cell transplant (ASCT). Participants in this group will be treated with four cycles of D-VRd which includes daratumumab subcutaneous (Dara-SC), bortezomib, lenalidomide and dexamethasone followed by the study medication. You will receive the study medication via an IV infusion. After that, participants will attend study visits for a maximum of 2.5 years after study medication.

You are expected to be in this research study for 2-3 years and then followed yearly until 15 years after dosing of the study medication.

Study-specific procedures that are being done beyond your standard of care will be provided at no cost to you.

Additional information can be found here: https://clinicaltrials.gov/study/NCT04133636

uvacancertrials@hscmail.mcc.virginia.edu

You may receive reimbursement for lodging and travel to help with your expenses for attending study visits.

Compensation

No Compensation