Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801939
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2023-03-24
Brief Title:
Cevostamab Following CAR T Cell Therapy for RRMM
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Phase 2 Study of Cevostamab Consolidation Following BCMA CAR T Cell Therapy for RelapsedRefractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 open-label single-arm single stage single-institution study with an initial safety run-in period Potential participants with relapsedrefractory myeloma who are undergoing standard of care commercially-available BCMA-directed CAR T cell therapy may be identified pre-CAR T cell infusion but are not consented and enrolled until at least 4-6 weeks after CAR T cell infusion once recovered from acute toxicities Note the lymphodepleting chemotherapy and CAR T cell therapy is being administered as part of standard clinical practice and is not considered part of this protocol Alternative lymphodepleting regimens other than fludarabine and cyclophosphamide eg in the setting of fludarabine shortages are acceptable Cevostamab will be given as an IV infusion once every 3 weeks starting roughly 10 weeks day 70 - 4 days post-CAR T cell infusion with subjects planned to receive 8 cycles initially Aiming to assess the impact of cevostamab consolidation post-BCMA CAR T cell therapy on rate of MRD-negative complete remission CR at 12 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None