Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348147
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-28
Brief Title:
Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma NDMM who are eligible for standard-of-care autologous stem cell transplantation ASCT Daratumumab lenalidomide bortezomib and dexamethasone Dara-RVd have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States As implemented in clinical trials Dara-RVd involves twice weekly bortezomib administration which is inconvenient for patients and may result in increased rates of limiting toxicity such as peripheral neuropathy Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice however a paucity of prospective data supporting this practice exists
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing
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?:
False
Is an FDA AA801 Violation?:
None