Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569147
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Open Label Study to Evaluate Safety Tolerability and Efficacy of Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 study will evaluate the safety tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis
Detailed Description:
This is a Phase III multi-center open-label study designed to evaluate the safety tolerability and efficacy of elranatamab in patients with relapsed or refractory light chain AL amyloidosis Phase 1 will enroll 4-20 participants beginning enrollment at Dose Level 0 If two or more participants at Level 0 experience DLT dose will be decreased to Level -1 Each participant will complete the 28-day dose-limiting toxicity DLT evaluation period prior to dosing the next patient Assuming a recommended phase 2 dose RP2D is found Phase 2 will enroll an additional 29 participants for a total of 49 participants
Dose level 0 consists of Cycle 1 12 mg D132 mg D4 76 mg D8 15 22 Cycle 2 76 mg on D1 D8 D15 and D22 If VGPR after Cycle 2 Cycles 3-6 76 mg on D1 8 15 and 22 If VGPR after Cycle 2 Cycles 3-6 76 mg on D1 and 15
Dose Level -1 consists of Cycle 1 12 mg D132 mg D4 76 mg D8 D22 Cycles 2-6 76 mg D1 and D15
Dose level 0 consists of Cycle 1 12 mg D132 mg D4 76 mg D8 15 22 Cycle 2 76 mg on D1 D8 D15 and D22 If VGPR after Cycle 2 Cycles 3-6 76 mg on D1 8 15 and 22 If VGPR after Cycle 2 Cycles 3-6 76 mg on D1 and 15
Dose Level -1 consists of Cycle 1 12 mg D132 mg D4 76 mg D8 D22 Cycles 2-6 76 mg D1 and D15
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