Ignite Creation Date:
2024-07-17 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497738
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-26
Brief Title:
A Prospective Study Comparing DRd With VRd-lite in Elderly Newly Diagnosed Multiple Myeloma
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
A Prospective Multi-center Open-label Cohort Study to Compare Daratumumab-Lenalidomide-Dexamethasone DRd With Modified Bortezomib-Lenalidomide-Dexamethasone VRd-lite in Elderly Newly Diagnosed Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-07
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 the study is to compare the efficacy and safety of daratumumab lenalidomide and dexamethasone DRd to that of modified bortezomib lenalidomide and dexamethasone VRd-lite in terms of progression-free survival and minimal residual disease negativity rate in elderly participants with newly diagnosed multiple myeloma
Detailed Description:
This is a prospective open-label multicentered cohort study This study will evaluate elderly participants with newly diagnosed multiple myeloma MM for whom hematopoietic stem cell transplant is not planned as initial therapy All the eligible participants can be free to choose to receive either daratumumab lenalidomide and dexamethasone DRd or modified bortezomib lenalidomide and dexamethasone VRd-lite Daratumumab 16 milligram per kilogram mgkg will be administered weekly for first 8 weeks Cycles 1 to 2 of treatment and then every other week for 16 weeks Cycles 3 to 6 then every 4 weeks Cycle 7 to 8 Bortezomib will be administered subcutaneously 13 mgm2 weekly of each 28-day cycle for Cycles 1-8 Lenalidomide will be administered at a dose of 25 mg orally on Days 1 through 21 of each 28-day cycle and dexamethasone will be administered at a dose of 20 mg twice a week for both treatment arms Participants in both treatment arms will continue at least lenalidomide maintenance until disease progression or unacceptable toxicityThe primary endpoint will be progression-free survival PFS and percentage of participants with Negative Minimal Residual Disease MRD Participant safety will be assessed throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None