Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518551
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Elotuzumab Iberdomide Dexamethasone Post Ide-Cel in RRMM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Study of Elotuzumab and Iberdomide and Dexamethasone Post Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The aim of this research study is to evaluate the efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma
The names of the study drugs involved in this study are
Iberdomide a type of cereblon E3 ligase modulator
Elotuzumab a type of monoclonal antibody
Dexamethasone a type of steroid
The names of the study drugs involved in this study are
Iberdomide a type of cereblon E3 ligase modulator
Elotuzumab a type of monoclonal antibody
Dexamethasone a type of steroid
Detailed Description:
This is a phase III open-label non-randomized single-stage study to evaluate the efficacy of Elotuzumab and Iberdomide therapy post-Idecabtagene Vicleucel in participants with relapsed and refractory multiple myeloma Iberdomide has demonstrated some antitumor activity in laboratory studies
The US Food and Drug Administration FDA has approved Elotuzumab as a treatment option for Multiple Myeloma Dexamethasone also FDA approved is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers such as myeloma and leukemias The US Food and Drug Administration FDA has not approved Iberdomide as a treatment for Multiple Myeloma
The research study procedures include screening for eligibility study treatment visits bone marrow biopsies blood and urine tests electrocardiograms ECGs X-rays and Positron Emission Tomography PET scans Computerized Tomography CT scans or Magnetic Resonance Imaging MRI scans
It is expected about 49 people will take part in this research study
Bristol-Myers Squibb and Celgene a BMS company are supporting this research study by providing study drug and providing funding for the trial
The US Food and Drug Administration FDA has approved Elotuzumab as a treatment option for Multiple Myeloma Dexamethasone also FDA approved is a type of steroid and is usually combined with other chemotherapy for the treatment of blood cancers such as myeloma and leukemias The US Food and Drug Administration FDA has not approved Iberdomide as a treatment for Multiple Myeloma
The research study procedures include screening for eligibility study treatment visits bone marrow biopsies blood and urine tests electrocardiograms ECGs X-rays and Positron Emission Tomography PET scans Computerized Tomography CT scans or Magnetic Resonance Imaging MRI scans
It is expected about 49 people will take part in this research study
Bristol-Myers Squibb and Celgene a BMS company are supporting this research study by providing study drug and providing funding for the trial
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