Ignite Creation Date:
2024-05-06 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05218603
Status:
RECRUITING
Last Update Posted:
2022-09-16
First Post:
2022-01-17
Brief Title:
Evaluation of Maintenance With Bortezomib Plus Daratumumab V-Dara After Induction With Bortezomib Melphalan Prednisone Plus Daratumumab VMP-Dara in Newly Diagnosed Multiple Myeloma MM Patients Non-eligible for autoSCT
Sponsor:
PETHEMA Foundation
Organization:
PETHEMA Foundation
Study Overview
Official Title:
A Prospective Observational Study to Evaluate the Maintenance With Bortezomib Plus Daratumumab V-Dara After Induction With Bortezomib Melphalan Prednisone Plus Daratumumab VMP-Dara in Newly Diagnosed Multiple Myeloma MM Patients Non-eligible for Autologous Stem Cell Transplantation ASCT Alcyone-optimized Real World Evidence RWE Data
Status:
RECRUITING
Status Verified Date:
2022-09
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 is a prospective observational single group and multicenter study to describe the effectiveness and safety of maintenance with V-Dara after induction with the VMP-Dara regimen in newly diagnosed MM patients who are not eligible for ASCT
Patients will be enrolled in the study during a regularly scheduled office visit in clinical practice screening and enrollment visit and followed during 3-4 years in what will be called the Observational Phase During this phase the patient will be followed by hisher doctor as per routine clinical practice according to hisher disease The patient will not suffer any changes in hisher treatment or follow-up due to hisher participation in the study The patient will receive standard clinical practice and heshe will not do any other study-specific visit
During this 3-4-year observational phase the patient might discontinue V or V-Daradepending on toxicity efficacy or due to other medical reasons according to hisher physician decision
Patients will be enrolled in the study during a regularly scheduled office visit in clinical practice screening and enrollment visit and followed during 3-4 years in what will be called the Observational Phase During this phase the patient will be followed by hisher doctor as per routine clinical practice according to hisher disease The patient will not suffer any changes in hisher treatment or follow-up due to hisher participation in the study The patient will receive standard clinical practice and heshe will not do any other study-specific visit
During this 3-4-year observational phase the patient might discontinue V or V-Daradepending on toxicity efficacy or due to other medical reasons according to hisher physician decision
Detailed Description:
This is a prospective observational single group and multicenter study to describe the effectiveness and safety of maintenance with V-Dara after induction with the VMP-Dara regimen in newly diagnosed MM patients who are not eligible for ASCT
Patients will be recruited only if patients have received induction therapy with VMP-Dara followed by V-Dara as maintenance therapy for at least one cycle prior to the start of the study treatment has to be previously decided as part of clinical practice This way patients must have already been treated with 9 cycles of VMP-Dara approximately 12 months and at least 1 cycle of V-Dara maintenance 1 month before entering the study This implies that the decision to prescribe this maintenance schedule is clearly unrelated to the decision of enrolling the patient into the study
Patients will be enrolled in the study during a regularly scheduled office visit in clinical practice screening and enrollment visit and followed during 3-4 years in what will be called the Observational Phase During this phase the patient will be followed by hisher doctor as per routine clinical practice according to hisher disease The patient will not suffer any changes in hisher treatment or follow-up due to hisher participation in the study The patient will receive standard clinical practice and heshe will not do any other study-specific visit
Observational Phase
Patients will be followed for 3-4 years since the inclusion in the study Once the patient is enrolled in the study retrospective data collection at the start and end of VMP-Dara induction will be collected Subjects who discontinue maintenance therapy before disease progression V or V-Dara will continue to have response rate evaluations PFS and toxicity recorded as per routine clinical practice until the end of the study or progression whatever comes first
During this observational follow-up both the duration of the initially prescribed V-Dara maintenance and the time when bortezomib is stopped before daratumumab if this ever happens the existence of potential adverse reactions and the fate of the disease in terms of progression and survival even though the maintenance only daratumumab could have been stopped will be documented for a total of up to 3-4 years Maintenance with V-Dara or just daratumumab once bortezomib is suspended can be finalized due to progression unacceptable toxicity or voluntary withdrawal
This observational study has the following objectives
Primary Objective
- To describe the effectiveness of V-Dara maintenance after VMPDara induction in patients with MM non-eligible for autologous stem cell transplantation in the Spanish clinical setting clinical practice
Secondary Objectives
Compare the effectiveness of VMP-Dara induction followed by V-Dara maintenance with the results of the Daratumumab arm of the Alcyone trial VMP-Dara followed by Dara maintenance
To describe the safety of the V-Dara maintenance therapy used in clinical practice after VMP-Dara
To evaluate the clinical effectiveness in different risk subgroups
Patients will be recruited only if patients have received induction therapy with VMP-Dara followed by V-Dara as maintenance therapy for at least one cycle prior to the start of the study treatment has to be previously decided as part of clinical practice This way patients must have already been treated with 9 cycles of VMP-Dara approximately 12 months and at least 1 cycle of V-Dara maintenance 1 month before entering the study This implies that the decision to prescribe this maintenance schedule is clearly unrelated to the decision of enrolling the patient into the study
Patients will be enrolled in the study during a regularly scheduled office visit in clinical practice screening and enrollment visit and followed during 3-4 years in what will be called the Observational Phase During this phase the patient will be followed by hisher doctor as per routine clinical practice according to hisher disease The patient will not suffer any changes in hisher treatment or follow-up due to hisher participation in the study The patient will receive standard clinical practice and heshe will not do any other study-specific visit
Observational Phase
Patients will be followed for 3-4 years since the inclusion in the study Once the patient is enrolled in the study retrospective data collection at the start and end of VMP-Dara induction will be collected Subjects who discontinue maintenance therapy before disease progression V or V-Dara will continue to have response rate evaluations PFS and toxicity recorded as per routine clinical practice until the end of the study or progression whatever comes first
During this observational follow-up both the duration of the initially prescribed V-Dara maintenance and the time when bortezomib is stopped before daratumumab if this ever happens the existence of potential adverse reactions and the fate of the disease in terms of progression and survival even though the maintenance only daratumumab could have been stopped will be documented for a total of up to 3-4 years Maintenance with V-Dara or just daratumumab once bortezomib is suspended can be finalized due to progression unacceptable toxicity or voluntary withdrawal
This observational study has the following objectives
Primary Objective
- To describe the effectiveness of V-Dara maintenance after VMPDara induction in patients with MM non-eligible for autologous stem cell transplantation in the Spanish clinical setting clinical practice
Secondary Objectives
Compare the effectiveness of VMP-Dara induction followed by V-Dara maintenance with the results of the Daratumumab arm of the Alcyone trial VMP-Dara followed by Dara maintenance
To describe the safety of the V-Dara maintenance therapy used in clinical practice after VMP-Dara
To evaluate the clinical effectiveness in different risk subgroups
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