Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06623630
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Lymphodepleting Total Body Irradiation TBI Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel Carvykti Cilta-cel for Multiple Myeloma MM Patients With Impaired Renal Function
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Safety and Feasibility Study of Lymphodepleting Total Body Irradiation TBI Plus Cyclophosphamide Prior to Ciltacabtagene Autoleucel Carvykti Cilta-cel for Multiple Myeloma MM Patients With Impaired Renal Function
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Treatment for relapsedrefractory multiple myeloma continues to evolve with the approval of highly effective anti-BCMA CAR T therapies in recent years However despite the high prevalence of renal insufficiency in this population pivotal clinical trials have excluded patients with impaired renal function leading to an urgent unmet clinical need to develop safe and effective lymphodepleting regimens prior to CAR T administration for this population In addition renal insufficiency is linked to poor disease-related outcomes and is highly associated with several underserved populations
This study is testing the hypotheses that
1 low-dose total body irradiation TBI in combination with cyclophosphamide Cy as lymphodepletion prior to administration of cilta-cel will be safe and tolerable in patients with multiple myeloma who have impaired renal function
2 low-dose TBI-Cy as lymphodepletion prior to cilta-cel will result in comparable CAR T expansionpersistence and disease response rates as those seen with standard lymphodepleting chemotherapy fludarabine cyclophosphamide
This study is testing the hypotheses that
1 low-dose total body irradiation TBI in combination with cyclophosphamide Cy as lymphodepletion prior to administration of cilta-cel will be safe and tolerable in patients with multiple myeloma who have impaired renal function
2 low-dose TBI-Cy as lymphodepletion prior to cilta-cel will result in comparable CAR T expansionpersistence and disease response rates as those seen with standard lymphodepleting chemotherapy fludarabine cyclophosphamide
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None