Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574126
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Open-Label Single Arm Multicenter Study of Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma GEM-CAR-HiRiSMM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAR-HiRiSMM
Brief Summary:
This is an open-label single arm multicenter interventional study with Dara-VRD followed by cilta-cel in high-risk smoldering multiple myeloma SMM patients
The primary objectives of this trial related with efficafy and safety of the treatment are i to evaluate the proportion of high-risk SMM patients with undetectable minimal residual disease MRD at 6 months 12 months and thereafter every 12 months up to 5 years after cilta-cel administration as well as the sustained undetectable MRD rate in the intent-to-treat ITT population ii to annotate frequency and severity of adverse events AE and serious adverse events SAE as well as data from laboratory tests aslo related with safety such as Immunoglobulin Ig G levels complete blood count CBC cytopenia adn T-cell populations Secondary objectives are related with response to therapy and will measure different categories of response and survival
The primary objectives of this trial related with efficafy and safety of the treatment are i to evaluate the proportion of high-risk SMM patients with undetectable minimal residual disease MRD at 6 months 12 months and thereafter every 12 months up to 5 years after cilta-cel administration as well as the sustained undetectable MRD rate in the intent-to-treat ITT population ii to annotate frequency and severity of adverse events AE and serious adverse events SAE as well as data from laboratory tests aslo related with safety such as Immunoglobulin Ig G levels complete blood count CBC cytopenia adn T-cell populations Secondary objectives are related with response to therapy and will measure different categories of response and survival
Detailed Description:
This is an open-label single arm multicenter interventional study with Dara-VRD followed by cilta-cel in high-risk smoldering multiple myeloma SMM patients JNJ-68284528 ciltacabtagene autoleucel cilta-cel is an autologous chimeric antigen receptor T cell CAR-T therapy that targets B-cell maturation antigen BCMA a molecule expressed on the surface of mature B-lymphocytes and malignant plasma cells PCs
Since the immune system is less impaired in early stages of the disease high-risk SMM would represent the ideal platform to evaluate the potential of Dara-VRD followed by cilta-cel as a curative approach in high-risk SMM Study participants will be assigned into 2 groups Participants in Group 1 will receive a maximum of 2 cycles of Dara-VRD induction therapy followed by apheresis and infusion of cilta-cel Participants in Group 2 will undergo apheresis followed by Dara-VRD induction and cilta-cel infusion
The primary objective is to assess the efficacy and safety of Daratumumab Bortezomib Lenalidomide and Dexamethasone Dara-VRD followed by cilta-cel in high-risk SMM The endpoints for the primary objective will be
To evaluate the proportion of high-risk SMM patients with undetectable minimal residual disease MRD at 6 months 12 months and thereafter every 12 months up to 5 years after cilta-cel administration as well as the sustained undetectable MRD rate in the intent-to-treat ITT population MRD will be evaluated in the bone marrow by Next Generation Flow and Next Generation Sequencing with sensitivity level of 10-5
Nature frequency severity and timing of adverse events AEs discontinuations due to AEs and serious adverse events SAEs
Selected safety laboratory test Immunoglobulin Ig G levels complete blood count CBC cytopenia and cluster of differentiation 4 CD4 T lymphocytes T cells
The key secondary objectives are
To further evaluate the efficacy of Dara-VRD followed by cilta-cel in high-risk SMM patients as measured by ORR as well as different response categories partial response PR very good partial response VGPR complete response CR and stringent CR sCR and duration of response DOR
To assess the survival OS and progression free survival PFS of patients with high-risk SMM
Since the immune system is less impaired in early stages of the disease high-risk SMM would represent the ideal platform to evaluate the potential of Dara-VRD followed by cilta-cel as a curative approach in high-risk SMM Study participants will be assigned into 2 groups Participants in Group 1 will receive a maximum of 2 cycles of Dara-VRD induction therapy followed by apheresis and infusion of cilta-cel Participants in Group 2 will undergo apheresis followed by Dara-VRD induction and cilta-cel infusion
The primary objective is to assess the efficacy and safety of Daratumumab Bortezomib Lenalidomide and Dexamethasone Dara-VRD followed by cilta-cel in high-risk SMM The endpoints for the primary objective will be
To evaluate the proportion of high-risk SMM patients with undetectable minimal residual disease MRD at 6 months 12 months and thereafter every 12 months up to 5 years after cilta-cel administration as well as the sustained undetectable MRD rate in the intent-to-treat ITT population MRD will be evaluated in the bone marrow by Next Generation Flow and Next Generation Sequencing with sensitivity level of 10-5
Nature frequency severity and timing of adverse events AEs discontinuations due to AEs and serious adverse events SAEs
Selected safety laboratory test Immunoglobulin Ig G levels complete blood count CBC cytopenia and cluster of differentiation 4 CD4 T lymphocytes T cells
The key secondary objectives are
To further evaluate the efficacy of Dara-VRD followed by cilta-cel in high-risk SMM patients as measured by ORR as well as different response categories partial response PR very good partial response VGPR complete response CR and stringent CR sCR and duration of response DOR
To assess the survival OS and progression free survival PFS of patients with high-risk SMM
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