Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT04656951
Status:
RECRUITING
Last Update Posted:
2022-04-05
First Post:
2020-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daratumumab for First Line Treatment of Transplant-ineligible Myeloma Patients Followed by Daratumumab Re-treatment at First Relapse
Sponsor:
University of Cologne
Organization:
Study Overview
Official Title:
Daratumumab for First Line Treatment of Transplant-ineligible Myeloma Patients Followed by Daratumumab Re-treatment at First Relapse
Status:
RECRUITING
Status Verified Date:
2022-04
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:
GMMG-DADA
Brief Summary:
Daratumumab for first line treatment of transplant-ineligible myeloma patients followed by daratumumab re-treatment at first relapse (GMMG-DADA)
Detailed Description:
The aim of the study is to investigate the safety and efficacy of daratumumab added to a standard induction regimen of bortezomib, cyclophosphamide and dexamethasone (VCD). A secondary aim is to assess the efficacy of maintenance therapy until progression using daratumumab in combination with bortezomib and dexamethasone. Thirdly the efficacy of a daratumumab-containing regimen at first relapse shall be tested following a daratumumab-containing first line regimen.
Rationale:
VCD has been established as a standard of care for first line therapy of transplant-eligible patients in Germany. The favorable toxicity profile makes this regimen also suitable for transplant-ineligible patients. Daratumumab has shown to be safe and efficacious in a variety of combinations such as with VMP, Vd or Rd. Using a reduced dose of cyclophosphamide the study shall investigate safety and efficacy of Dara-VCD in the transplant-ineligible patient population.
Maintenance therapy has become standard of care in transplant-eligible and non-eligible patients. However, there is uncertainty whether a single agent maintenance is sufficient or whether a combination therapy is necessary. In this study the safety and efficacy of maintenance with daratumumab in combination with bortezomib and dexamethasone will be assessd with a focus on MRD negativity as a novel endpoint.
The multitude of treatment options at first relapse has generated the need to find an optimal sequence of therapy regimens in first and second line. In particular it is unclear whether the efficacy of daratumumab at relapse is affected by its prior use as part of the first line treatment. Patients in this study will relapse on or after a daratumumab-containing maintenance and shall receive DRd at first relapse. In the POLLUX study patients received DRd but had no prior exposure to daratumumab. Therefore, patients included into the POLLUX study can serve as an indirect control cohort for the present study. If in the present study the PFS after DRd is similar to the PFS of the comparable cohort from the POLLUX study, the assumption is supported that prior exposure to daratumumab does not impair the activity of a subsequent daratumumab-containing regimen at relapse. In addition, the overall efficacy of the whole protocol treatment will be assessed by analyzing PFS2 after relapse from study inclusion (PFS2).
Rationale:
VCD has been established as a standard of care for first line therapy of transplant-eligible patients in Germany. The favorable toxicity profile makes this regimen also suitable for transplant-ineligible patients. Daratumumab has shown to be safe and efficacious in a variety of combinations such as with VMP, Vd or Rd. Using a reduced dose of cyclophosphamide the study shall investigate safety and efficacy of Dara-VCD in the transplant-ineligible patient population.
Maintenance therapy has become standard of care in transplant-eligible and non-eligible patients. However, there is uncertainty whether a single agent maintenance is sufficient or whether a combination therapy is necessary. In this study the safety and efficacy of maintenance with daratumumab in combination with bortezomib and dexamethasone will be assessd with a focus on MRD negativity as a novel endpoint.
The multitude of treatment options at first relapse has generated the need to find an optimal sequence of therapy regimens in first and second line. In particular it is unclear whether the efficacy of daratumumab at relapse is affected by its prior use as part of the first line treatment. Patients in this study will relapse on or after a daratumumab-containing maintenance and shall receive DRd at first relapse. In the POLLUX study patients received DRd but had no prior exposure to daratumumab. Therefore, patients included into the POLLUX study can serve as an indirect control cohort for the present study. If in the present study the PFS after DRd is similar to the PFS of the comparable cohort from the POLLUX study, the assumption is supported that prior exposure to daratumumab does not impair the activity of a subsequent daratumumab-containing regimen at relapse. In addition, the overall efficacy of the whole protocol treatment will be assessed by analyzing PFS2 after relapse from study inclusion (PFS2).
Study Oversight
Has Oversight DMC:
False
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?: