Ignite Creation Date:
2024-05-05 @ 10:13 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01054144
Status:
COMPLETED
Last Update Posted:
2021-10-13
First Post:
2010-01-21
Brief Title:
Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Study of Response Adapted Therapy Using Single Agent Lenalidomide in Older Adults With Newly Diagnosed Standard Risk Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The purpose of this research is to estimate the effectiveness of a response adapted approach with the use of the drug lenalidomide in the treatment of older adults with newly diagnosed standard risk multiple myeloma This means that participants will be given the study drug lenalidomide but depending on how they respond to this drug they may also be given dexamethasone andor prednisone to help with their treatment
Detailed Description:
Summary Patients will be started on the study drug lenalidomide on Day 1 Cycle 1 Lenalidomide is a capsule that is to be taken orally by mouth If the patients disease progresses after 2 cycles of therapy a low dose of dexamethasone will be added If the patients disease is stable after 2 cycles of therapy the use of an alternate corticosteroid prednisone will be added to the lenalidomide therapy they are receiving Dexamethasone and prednisone are in tablet form and will be taken orally by mouth However if the patient has a minimal response after an additional 2 cycles of lenalidomide therapy the therapy will be continued until their disease progresses See the intervention descriptions for further details
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RV-MM-PI-0454 | OTHER_GRANT | Celgene | None |
| 108562 | OTHER | None | None |