Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04653246
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2020-11-27
Brief Title:
Isatuximab Lenalidomide Bortezomib and Dexamethasone in NDMM
Sponsor:
Jacob Laubach MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase 2 Multi-Center Single-Arm Open-Label Study to Evaluate the Efficacy and Safety of the Combination Regimen Isatuximab Lenalidomide Bortezomib and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-05
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 research is testing whether the investigational drug isatuximab is safe and effective when used in combination with standard agents for the treatment of newly diagnosed multiple myeloma
Detailed Description:
This is a multi-center single-arm open-label Phase 2 study in patients with newly diagnosed multiple myeloma NDMM eligible for high dose therapy HDT and autologous stem cell transplant ASCT
In this research study investigators are evaluating whether isatuximab is safe and effective in participants with newly diagnosed multiple myeloma when given in combination with lenalidomide bortezomib and dexamethsone
This research study involves administration of a four-drug chemotherapy regimen that combines the Investigational drug isatuximab with a standard chemotherapy regimen comprised of lenalidomide bortezomib and dexamethasone
This 4-drug regimen is not considered standard of the treatment of newly diagnosed multiple myeloma
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has approved lenalidomide bortezomib and dexamethasone as treatment options for this disease but the combination of these agents with isatuximab hasnt been approved
In this research study investigators are evaluating whether isatuximab is safe and effective in participants with newly diagnosed multiple myeloma when given in combination with lenalidomide bortezomib and dexamethsone
This research study involves administration of a four-drug chemotherapy regimen that combines the Investigational drug isatuximab with a standard chemotherapy regimen comprised of lenalidomide bortezomib and dexamethasone
This 4-drug regimen is not considered standard of the treatment of newly diagnosed multiple myeloma
This research study is a Phase II clinical trial Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether the drug works in treating a specific disease Investigational means that the drug is being studied
The US Food and Drug Administration FDA has approved lenalidomide bortezomib and dexamethasone as treatment options for this disease but the combination of these agents with isatuximab hasnt been approved
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