Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05828511
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-04-12
Brief Title:
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
Phase 12 Study of Linvoseltamab Anti-BCMA X Anti-CD3 Bispecific Antibody in Previously Untreated Patients With Symptomatic Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT05164250
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
LINKER-MM4
Brief Summary:
This study is researching an experimental drug called linvoseltamab called study drug The study is focused on participants with newly diagnosed multiple myeloma NDMM who are eligible for high dose chemotherapy with autologous stem cell transplantation transplant-eligible or ineligible for autologous stem cell transplantation transplant-ineligible
The aim of this clinical trial is to study the safety tolerability how the body reacts to the drug and effectiveness tumor shrinkage of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM
This study consists of 2 phases
In Phase 1 the study drug will be given to participants to study the side effects of the study drug and to establish the regimen initial doses and full dose of the study drug to be given to participants in Phase 2
In Phase 2 the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of the study drug to shrink the tumor multiple myeloma in participants with NDMM
The study is looking at several research questions including
What side effects may happen from taking linvoseltamab
What the right dosing regimen is for linvoseltamab
How many participants treated with linvoseltamab have improvement of their disease and for how long
The effects of linvoseltamab study treatment before and after transplant
How much linvoseltamab is in the blood at different times
Whether the body makes antibodies against linvoseltamab which could make the drug less effective or could lead to side effects
The aim of this clinical trial is to study the safety tolerability how the body reacts to the drug and effectiveness tumor shrinkage of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM
This study consists of 2 phases
In Phase 1 the study drug will be given to participants to study the side effects of the study drug and to establish the regimen initial doses and full dose of the study drug to be given to participants in Phase 2
In Phase 2 the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of the study drug to shrink the tumor multiple myeloma in participants with NDMM
The study is looking at several research questions including
What side effects may happen from taking linvoseltamab
What the right dosing regimen is for linvoseltamab
How many participants treated with linvoseltamab have improvement of their disease and for how long
The effects of linvoseltamab study treatment before and after transplant
How much linvoseltamab is in the blood at different times
Whether the body makes antibodies against linvoseltamab which could make the drug less effective or could lead to side effects
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-500800-24-00 | REGISTRY | EU CT Number | None |