Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05847569
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-04-27
Brief Title:
Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase II Trial for Evaluation of Alternate Doses and Dosing Schedules of Belantamab Mafodotin in Triple-Class Refractory Multiple Myeloma
Status:
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:
None
Brief Summary:
This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back after a period of improvement recurrent andor does not respond to treatment or that has not responded to previous treatment refractory Belantamab mafodotin is a monoclonal antibody belantamab linked to a chemotherapy drug mafodotin Belantamab is a form of targeted therapy because it attaches to specific molecules receptors on the surface of cancer cells known as BCMA receptors and delivers mafodotin to kill them This trial may help researchers determine if alternate doses and dosing schedules work better in preventing certain side effects such as eye toxicity and treating patients with recurrent or refractory multiple myeloma
Detailed Description:
PRIMARY OBJECTIVE
I To assess the grade 34 keratopathy-free rate at the time of dose 4 of an alternative dosedosing schedule of belantamab mafodotin in patients with relapsed or refractory multiple myeloma RRMM
SECONDARY OBJECTIVES
I To assess the overall response rate ORR partial response or better of an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
II To assess the safety of an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
III To assess the time to progression TTP of an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
IV To assess the progression free survival PFS with an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
V To assess the overall survival OS with an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
VI To assess the minimal residual disease MRD negativity rate in patients who have achieved a complete response CR with an alternative dosedosing schedule of belantamab mafodotin
CORRELATIVE AND PHARMACODYNAMIC RESEARCH OBJECTIVES
I To assess the association of pre-treatment serum BCMA levels as well as serum BCMA levels throughout treatment with ORR and PFS to an alternative treatment schedule of belantamab mafodotin
II To assess the pharmacokinetics of this alternative dosedosing schedule of belantamab mafodotin
OUTLINE Patients are randomized to 1 of 2 groups
GROUP I Patients receive low dose belantamab mafodotin intravenously IV on day 1 of each cycle Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity All patients undergo a computed tomography CT scan a magnetic resonance image MRI scan or a positron emission tomography PETCT scan during screening and patients with plasmacytoma a multiple myeloma MM tumor in bone or soft tissue also undergo imaging scans on study Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial
GROUP II Patients receive belantamab mafodotin IV on day 1 Cycle repeasts at 3 weeks for the next cycle and then every 6 weeks for subsequent cycles in the absence of disease progression or unacceptable toxicity All patients undergo a CT scan a MRI scan or a PETCT scan during screening and patients with plasmacytoma a MM tumor in bone or soft tissue also undergo imaging scans on study Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial
After completion of trial treatment patients are followed up every 12 weeks for up to 5 years
I To assess the grade 34 keratopathy-free rate at the time of dose 4 of an alternative dosedosing schedule of belantamab mafodotin in patients with relapsed or refractory multiple myeloma RRMM
SECONDARY OBJECTIVES
I To assess the overall response rate ORR partial response or better of an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
II To assess the safety of an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
III To assess the time to progression TTP of an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
IV To assess the progression free survival PFS with an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
V To assess the overall survival OS with an alternative dosedosing schedule of belantamab mafodotin in patients with RRMM
VI To assess the minimal residual disease MRD negativity rate in patients who have achieved a complete response CR with an alternative dosedosing schedule of belantamab mafodotin
CORRELATIVE AND PHARMACODYNAMIC RESEARCH OBJECTIVES
I To assess the association of pre-treatment serum BCMA levels as well as serum BCMA levels throughout treatment with ORR and PFS to an alternative treatment schedule of belantamab mafodotin
II To assess the pharmacokinetics of this alternative dosedosing schedule of belantamab mafodotin
OUTLINE Patients are randomized to 1 of 2 groups
GROUP I Patients receive low dose belantamab mafodotin intravenously IV on day 1 of each cycle Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity All patients undergo a computed tomography CT scan a magnetic resonance image MRI scan or a positron emission tomography PETCT scan during screening and patients with plasmacytoma a multiple myeloma MM tumor in bone or soft tissue also undergo imaging scans on study Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial
GROUP II Patients receive belantamab mafodotin IV on day 1 Cycle repeasts at 3 weeks for the next cycle and then every 6 weeks for subsequent cycles in the absence of disease progression or unacceptable toxicity All patients undergo a CT scan a MRI scan or a PETCT scan during screening and patients with plasmacytoma a MM tumor in bone or soft tissue also undergo imaging scans on study Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial
After completion of trial treatment patients are followed up every 12 weeks for up to 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-03039 | REGISTRY | None | None |
| MC210812 | OTHER | None | None |
| 22-001207 | OTHER | Mayo Clinic Institutional Review Board | None |