Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-04-16
Brief Title:
Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
The First Affiliated Hospital of Soochow University
Study Overview
Official Title:
A Single-arm Prospective Study of the Treatment in High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
Status:
NOT_YET_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:
The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction consolidation therapy - ASCT in newly diagnosed high-risk multiple myeloma patients It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib lenalidomide and dexamethasone DKRD - ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma Participants will receive bortezomib based induction therapy for one cycle and then DKRD induction for 3 cyclesASCT DKRD consolidation for 2-4 cycles and DKR maintenance treatmentadjusted according to MRD negativity after consolidation therapy
Detailed Description:
Daratumumab carfilzomib lenalidomide and dexamethasone are commonly used drugs for multiple myeloma The efficacy of their combination has been proven in newly diagnosed multiple myeloma patients including high-risk patients while there are no relevant data in the Chinese population Therefore the efficacy of DKRd regimen in Chinese HR-NDMM patients needs to be further explored
It is a prospective single-arm study High riskHR-NDMM Patients with will be recruited and their baseline data will be collected Patients will be treated with bortezomib lenalidomide and dexamethasone for the first cycle in order to urgently relieve bone pain renal insufficiency hypercalcemia and other symptoms during which screening and evaluation is conducted And then patients will be treated with 3 cycles of daratumumab carfilzomib K lenalidomide R combined with dexamethasone d after which stem cells were collected from transplant-eligible followed by autologous hematopoietic stem cell transplantation two cycles of DKRD consolidation DKR maintenance treatment for more than one year If continuous MRD negativity for more than one year patients will be treated with only lenalidomide maintenance Transplant-noneligible patients will be treated with DKRD for 4-cycles consolidation therapy without transplantation and then entered DKR maintenance therapy If patients with continuous MRD negativity for more than one year will be treated with only lenalidomide maintenance Follow-up was conducted and outcome indicators were collected to explore the efficacy and safety of DKRd treatment in HR-NDMM patients The results of this study are expected to provide new treatment options and corresponding dosages for Chinese HR-NDMM patients thereby improving patient outcomes and reducing the overall disease burden
It is a prospective single-arm study High riskHR-NDMM Patients with will be recruited and their baseline data will be collected Patients will be treated with bortezomib lenalidomide and dexamethasone for the first cycle in order to urgently relieve bone pain renal insufficiency hypercalcemia and other symptoms during which screening and evaluation is conducted And then patients will be treated with 3 cycles of daratumumab carfilzomib K lenalidomide R combined with dexamethasone d after which stem cells were collected from transplant-eligible followed by autologous hematopoietic stem cell transplantation two cycles of DKRD consolidation DKR maintenance treatment for more than one year If continuous MRD negativity for more than one year patients will be treated with only lenalidomide maintenance Transplant-noneligible patients will be treated with DKRD for 4-cycles consolidation therapy without transplantation and then entered DKR maintenance therapy If patients with continuous MRD negativity for more than one year will be treated with only lenalidomide maintenance Follow-up was conducted and outcome indicators were collected to explore the efficacy and safety of DKRd treatment in HR-NDMM patients The results of this study are expected to provide new treatment options and corresponding dosages for Chinese HR-NDMM patients thereby improving patient outcomes and reducing the overall disease burden
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?:
None
Is an FDA AA801 Violation?:
None