Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645678
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-14
Brief Title:
Mezigdomide and Elranatamab for Relapsed Andor Refractory Multiple Myeloma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase III Study of Mezigdomide and Elranatamab for Relapsedrefractory Multiple Myeloma Patients
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:
MELT-MM
Brief Summary:
The goal of this clinical trial is to find out how well a combination of two medicines mezigdomide and elranatamab works in treating patients with refractoryrelapsed multiple myeloma
Detailed Description:
This is a phase III 2 parts open-label single arm multicenter study to evaluate the efficacy and safety of elranatamab in combination with mezigdomide
Part 1 safety cohort Since the combination of elranatamab with mezigdomide has not previously been evaluated Part 1 safety cohort of the study will be conducted in up to approximately 12 participants to select the optimal RP2D and to assess the safety tolerability and preliminary efficacy
Part 2 expansion cohort In Part 2 expansion cohort approximately 63 participants will be enrolled The primary objective of Part 2 is to determine the overall response rate per IMWG criteria at 24 months after enrollment Participants will receive elranatamab mezigdomide and dexamethasone
Part 1 safety cohort Since the combination of elranatamab with mezigdomide has not previously been evaluated Part 1 safety cohort of the study will be conducted in up to approximately 12 participants to select the optimal RP2D and to assess the safety tolerability and preliminary efficacy
Part 2 expansion cohort In Part 2 expansion cohort approximately 63 participants will be enrolled The primary objective of Part 2 is to determine the overall response rate per IMWG criteria at 24 months after enrollment Participants will receive elranatamab mezigdomide and dexamethasone
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