Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216158
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-01-09
Brief Title:
Iberdomide Vs Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma
Sponsor:
University of Heidelberg Medical Center
Organization:
University of Heidelberg Medical Center
Study Overview
Official Title:
A Randomized Phase III Trial Assessing Iberdomide Versus Iberdomide Plus Isatuximab Maintenance Therapy Post Autologous Hematopoietic Stem-Cell Transplantation in Patients with Newly Diagnosed Multiple Myeloma
Status:
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:
The goal of this clinical trial is to compare a maintenance therapy consisting of iberdomide and isatuximab with an iberdomide-only regimen The trial is the subsequent maintenance therapy to GMMG-HD8DSMM XIX trial for patients with newly-diagnosed multiple myeloma The main question it aims to answer is
Will the addition of isatuximab lead to decreased amounts of measurable myeloma cells in the bone marrow after two years
Will the addition of isatuximab lead to decreased amounts of measurable myeloma cells in the bone marrow after two years
Detailed Description:
Prospective multicentre randomised parallel group open phase III clinical trial for a maintenance therapy for patients who underwent an induction therapy and autologous stem cell transplantation in the GMMG-HD8DSMM XIX trial
Investigational Medicinal Product Iberdomid oral isatuximab subcutaneous administration via a wearable injector system
Randomisation will be performed centrally by GMMGDSMM offices after verification of the eligibility of the patient At the time of study inclusion randomization will be performed into arm A iberdomide or arm B iberdomide isatuximab Randomization will be stratified by centrally assessed MRD negativity status yes vs no vs unknown assessed by NGF from BMA sensitivity of 10-5 independent of standard IMWG response and number of HDMASCT single vs tandem
Patients randomized in arm A will receive 39 cycles of the drug iberdomide a Cereblon E3 Ubiquitin Ligase Modulating Drug CELMoD that shares structural similarities to the immunomodulatory compounds IMiDs such as thalidomide and lenalidomide Each cycle will last for 29 days Patients in arm B will receive the same the 39 cycles of iberdomide plus monoclonal anti-CD38 antibody isatuximab subcutaneously In both arms patients will receive 20 mg dexamethasone in cycle 1 on the same days as the isatuximab administration in Arm B End of study will be after 36 months of the maintenance therapy
There is one primary objective
- Demonstration of superiority of iberdomide plus isatuximab compared to iberdomide with respect to bone marrow minimal residual disease MRD negativity rates sensitivity 2x10-6 via next-generation flow cytometry NGF after two years of maintenance therapy
There is one key secondary objective
- PFS defined as time from randomization to disease progression or death from any cause whichever occurs first
Further secondary objectives are
Rates of sustained MRD negativity at sensitivity levels of 10-5 and 2x10-6 via NGF from BMA after 1 2 and 3 years of maintenance therapy
Conversion from MRD positive to negative at sensitivity levels of 10-5 and 2x10-6 via NGF from BMA
Rates of best overall response to treatment BOR
Rates of partial response PR very good partial response VGPR complete response CR and stringent complete response sCR
Time-to-next-treatment TTNT
PFS on subsequent line of therapy
Overall survival OS
Improvement of IMWG response categories PR VGPR CR sCR
Proportions of patients in both treatment arms maintaining BOR and CR from baseline
Assessment of quality-of-life QoL via the EORTC-QLQC30 EORTC-QLQMY20 and EQ-5D-5L questionnaires
Investigational Medicinal Product Iberdomid oral isatuximab subcutaneous administration via a wearable injector system
Randomisation will be performed centrally by GMMGDSMM offices after verification of the eligibility of the patient At the time of study inclusion randomization will be performed into arm A iberdomide or arm B iberdomide isatuximab Randomization will be stratified by centrally assessed MRD negativity status yes vs no vs unknown assessed by NGF from BMA sensitivity of 10-5 independent of standard IMWG response and number of HDMASCT single vs tandem
Patients randomized in arm A will receive 39 cycles of the drug iberdomide a Cereblon E3 Ubiquitin Ligase Modulating Drug CELMoD that shares structural similarities to the immunomodulatory compounds IMiDs such as thalidomide and lenalidomide Each cycle will last for 29 days Patients in arm B will receive the same the 39 cycles of iberdomide plus monoclonal anti-CD38 antibody isatuximab subcutaneously In both arms patients will receive 20 mg dexamethasone in cycle 1 on the same days as the isatuximab administration in Arm B End of study will be after 36 months of the maintenance therapy
There is one primary objective
- Demonstration of superiority of iberdomide plus isatuximab compared to iberdomide with respect to bone marrow minimal residual disease MRD negativity rates sensitivity 2x10-6 via next-generation flow cytometry NGF after two years of maintenance therapy
There is one key secondary objective
- PFS defined as time from randomization to disease progression or death from any cause whichever occurs first
Further secondary objectives are
Rates of sustained MRD negativity at sensitivity levels of 10-5 and 2x10-6 via NGF from BMA after 1 2 and 3 years of maintenance therapy
Conversion from MRD positive to negative at sensitivity levels of 10-5 and 2x10-6 via NGF from BMA
Rates of best overall response to treatment BOR
Rates of partial response PR very good partial response VGPR complete response CR and stringent complete response sCR
Time-to-next-treatment TTNT
PFS on subsequent line of therapy
Overall survival OS
Improvement of IMWG response categories PR VGPR CR sCR
Proportions of patients in both treatment arms maintaining BOR and CR from baseline
Assessment of quality-of-life QoL via the EORTC-QLQC30 EORTC-QLQMY20 and EQ-5D-5L questionnaires
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?:
False
Is an FDA AA801 Violation?:
None