Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05955508
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2023-07-13
Brief Title:
A Proof-of-Concept Trial to Study the Safety and Activity of Linvoseltamab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
Phase 2 Study of Linvoseltamab in Patients With Smoldering Multiple Myeloma at High Risk of Progression to Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is researching an investigational drug called linvoseltamab study drug in participants at high risk of developing multiple myeloma MM a group commonly labeled as high-risk smoldering multiple myeloma HR-SMM
The aim of the study is to understand the safety and tolerability how your body reacts to linvoseltamab as well as the effectiveness how well linvoseltamab eliminates plasma cells and prevents the development of MM of the study drug There are 2 parts to the study
In Part 1 linvoseltamab will be given to a small number of participants to study the early side effects safety of the study drug and make sure the treatment is acceptable
In Part 2 linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat HR-SMM and prevent progression to MM
The study is looking at several other research questions including
How many participants treated with linvoseltamab study drug have improvement of their HR-SMM
What side effects may happen from taking the study drug
How much study drug is in your blood at different times
Whether the body makes antibodies against the study drug which could make the drug less effective or could lead to side effects
The aim of the study is to understand the safety and tolerability how your body reacts to linvoseltamab as well as the effectiveness how well linvoseltamab eliminates plasma cells and prevents the development of MM of the study drug There are 2 parts to the study
In Part 1 linvoseltamab will be given to a small number of participants to study the early side effects safety of the study drug and make sure the treatment is acceptable
In Part 2 linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat HR-SMM and prevent progression to MM
The study is looking at several other research questions including
How many participants treated with linvoseltamab study drug have improvement of their HR-SMM
What side effects may happen from taking the study drug
How much study drug is in your blood at different times
Whether the body makes antibodies against the study drug 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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503524-11-00 | OTHER | EUCT Number | None |