Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463717
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-05
Brief Title:
Primary Multiple Myeloma Who Achieved MRD Negativity After Induction Therapy ASCT or Not
Sponsor:
First Affiliated Hospital of Zhejiang University
Organization:
First Affiliated Hospital of Zhejiang University
Study Overview
Official Title:
Comparing the Efficacy and Safety of Autologous Hematopoietic Stem-cell Transplantation Versus Non Transplantation Regimen in Primary Multiple Myeloma Achieved MRD Negativity After Induction A Multiple Center Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2023-12
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 observational study is to compare the efficacy and safety of autologous hematopoietic stem-cell transplantation ASCT versus non ASCT regimens in primary multiple myeloma patients achieved MRD negativity after induction
The main question it aims to answer is
In primary multiple myeloma patients who achieved MRD negativity after induction non ASCT regimens are not inferior to ASCT or not Participants will receive ASCT or non ASCT regimen according to their own choice
Researchers will compare ASCT and non ASCT group see if any significant difference in efficacy and safety
The main question it aims to answer is
In primary multiple myeloma patients who achieved MRD negativity after induction non ASCT regimens are not inferior to ASCT or not Participants will receive ASCT or non ASCT regimen according to their own choice
Researchers will compare ASCT and non ASCT group see if any significant difference in efficacy and safety
Detailed Description:
Background Multiple myeloma MM is third most common hematological malignancy For newly diagnosed MM patients who are transplantation eligible the current standard treatment regimen is induction therapy with bortezomib plus lenalidomide plus dexamethasone VRD high-dose melphalan 200 mgm2 followed by autologous stem cell transplantation MEL200-ASCT and maintenance therapy with lenalidomide andor proteasome inhibitors However MEL200-ASCT requires hospitalization and may induces toxic side effects In recent years multiple MM international research centers have explored and compared the efficacy of different treatment regimens such as bortezomib plus melphalan plus prednisone bortezomib plus lenalidomide plus dexamethasone carfilzomib plus cyclophosphamide plus dexamethasone and carfilzomib plus lenalidomide plus dexamethasone with MEL200-ASCT and found that MEL200-ASCT has a higher progression free survival compared to the aforementioned chemotherapy regimens but failed to show benefit in overall survival The advantage of MEL200-ACT in progression free survival can be attributed to its ability to achieve deeper therapeutic responses compared to chemotherapy regimens including a higher complete response CR very good partial response VGPR and a higher negative rate for minimal residual disease MRD or sustained negative rate for MRD
MRD was introduced by the International Myeloma Working Group in 2016 which implies deeper clinical response than CR and can be detected by flow cytometry or second-generation sequencing with a sensitivity of at least 10-5 Research has shown that MRD is the most powerful prognostic factor for MM and MM patients with negative MRD have a significant superior survival than MRD positive patients As mentioned earlier MEL200-ASCT induces deeper therapeutic response than chemotherapy and results in superior progression survival So in patients who have already reached MRD negative after VRD induction treatment does MEL200-ASCT still have an advantage in progression free survival compared to chemotherapy A study comparing the efficacy of MEL200-ASCT with carfilzomib plus cyclophosphamide and dexamethasone found that among patients with detectable MRD after induction therapy MEL200-ASCT group had a higher progression free survival rate than chemotherapy However there was no evidence suggesting that MEL200-ASCT is beneficial for patients who have already obtained MRD negative after induction therapy
Therefore this study aims to investigate the status of MEL200-ACT in newly diagnosed MM patients who have achieved MRD negative after induction therapy with the current standard protocol
Data collection Patient who met the enrollment criteria is unselected recorded and followed regularly
Sample size calculation This study aims to demonstrate that non ASCT regimens is not inferior to high dose melphalan followed by ASCT in terms of progression free survival in MM patients who already obtained MRD negative after induction therapy Based on available date 2-year progression free survival rate was 85 for patients received MRD negativity after induction therapy and followed by ASCT Therefore the investigators assure that 2-year progression free survival rate of non ASCT regimen group should not be less than 75 ie a non-inferiority margin of 10 Using a one-sided non-inferiority test for two exponential survival curves with 0025 alpha 08 power a common exponential dropout rate of 10 and number of non ASCT and ASCT patients in a 32 ratio 126 patients for non ASCT and 84 patients for ASCT group are required
MRD was introduced by the International Myeloma Working Group in 2016 which implies deeper clinical response than CR and can be detected by flow cytometry or second-generation sequencing with a sensitivity of at least 10-5 Research has shown that MRD is the most powerful prognostic factor for MM and MM patients with negative MRD have a significant superior survival than MRD positive patients As mentioned earlier MEL200-ASCT induces deeper therapeutic response than chemotherapy and results in superior progression survival So in patients who have already reached MRD negative after VRD induction treatment does MEL200-ASCT still have an advantage in progression free survival compared to chemotherapy A study comparing the efficacy of MEL200-ASCT with carfilzomib plus cyclophosphamide and dexamethasone found that among patients with detectable MRD after induction therapy MEL200-ASCT group had a higher progression free survival rate than chemotherapy However there was no evidence suggesting that MEL200-ASCT is beneficial for patients who have already obtained MRD negative after induction therapy
Therefore this study aims to investigate the status of MEL200-ACT in newly diagnosed MM patients who have achieved MRD negative after induction therapy with the current standard protocol
Data collection Patient who met the enrollment criteria is unselected recorded and followed regularly
Sample size calculation This study aims to demonstrate that non ASCT regimens is not inferior to high dose melphalan followed by ASCT in terms of progression free survival in MM patients who already obtained MRD negative after induction therapy Based on available date 2-year progression free survival rate was 85 for patients received MRD negativity after induction therapy and followed by ASCT Therefore the investigators assure that 2-year progression free survival rate of non ASCT regimen group should not be less than 75 ie a non-inferiority margin of 10 Using a one-sided non-inferiority test for two exponential survival curves with 0025 alpha 08 power a common exponential dropout rate of 10 and number of non ASCT and ASCT patients in a 32 ratio 126 patients for non ASCT and 84 patients for ASCT group are required
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