Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179888
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-12-21
Brief Title:
Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase 2 Study of Iberdomide Maintenance Therapy Following Idecabtagene Vicleucel CAR-T in Multiple Myeloma Patients
Status:
RECRUITING
Status Verified Date:
2024-08
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 phase II trial compares iberdomide maintenance therapy to disease monitoring for improving survival in patients who have received idecabtagene vicleucel a type of chimeric antigen receptor T-cell CAR-T therapy for multiple myeloma The usual approach after treatment with idecabtagene vicleucel is to monitor the multiple myeloma without giving myeloma medications There is currently no medication approved specifically for use after idecabtagene vicleucel treatment Upon administration iberdomide modifies the immune system and activates immune cells called T-cells which could enhance the effectiveness of idecabtagene vicleucel Iberdomide may keep multiple myeloma under control for longer than the usual approach disease monitoring after idecabtagene vicleucel and may help multiple myeloma patients live longer
Detailed Description:
PRIMARY OBJECTIVES
I To establish and confirm the safety and dose of iberdomide as maintenance after idecabtagene vicleucel ide-cel CAR-T Safety run-in II To assess whether iberdomide maintenance therapy after idecabtagene vicleucel CAR-T cell therapy increases progression-free survival PFS relative to observation without additional therapy Randomized phase II
SECONDARY OBJECTIVES
I To demonstrate anti-tumor activity defined as conversion from non-minimal residual disease MRD complete response CRstringent CR sCR status to MRD-negative CRsCR as well as improvement in PFS in the safety run-in cohort Safety run-in II To estimate the rate of conversion from MRD-positive at baseline to MRD-negative at any time point post-initiation of iberdomide maintenance or observation without additional therapy Key secondary objective Randomized phase II III To estimate overall survival OS distribution post-initiation of iberdomide maintenance or observation without additional therapy Key secondary objective Randomized phase II IV To estimate the minimal residual disease MRD-negativity rate at pre-registration and at one year post-initiation of iberdomide maintenance or observation without additional therapy Randomized phase II V To estimate rate of deepening hematological response among patients with measurable multiple myeloma MM post-initiation of iberdomide maintenance or observation without additional therapy Randomized phase II VI To evaluate the safety profile of iberdomide maintenance Randomized phase II VII To evaluate the peripheral blood immunophenotype before and during iberdomide maintenance or observation without additional therapy Randomized phase II VIII To evaluate persistence of CAR-T cells with iberdomide maintenance or observation without additional therapy Randomized phase II
CORRELATIVE SCIENCE OBJECTIVES
I To estimate the minimal residual disease MRD-negativity rate at start of maintenance and at one year post-initiation of maintenance or observation
II To estimate the sustained MRD-negativity rate III To estimate the rate of conversion from MRD-positive to MRD-negative Key objective IV To evaluate the peripheral blood immunophenotype before and during maintenance therapy or observation
V To evaluate the persistence of CAR-T cells VI To evaluate B-cell maturation antigen BCMA protein expression by immunohistochemistry on myeloma cells from patients that have relapsedrecurrent disease
OUTLINE Patients are randomized to 1 of 2 groups
GROUP 1 Patients undergo disease monitoring at monthly clinic visits until disease progression Patients also undergo bone marrow aspiration and biopsy throughout the trial undergo collection of blood samples at screening and on study and undergo positron emission tomography PETcomputed tomography CT andor skeletal survey x-ray CT or magnetic resonance imaging MRI at screening and then as clinically indicated
GROUP 2 Patients receive iberdomide orally PO once daily QD on days 1-21 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo bone marrow aspiration and biopsy throughout the trial undergo collection of blood samples at screening and on study and undergo PETCT andor skeletal survey x-ray CT or MRI at screening and then as clinically indicated
After completion of study treatment patients are followed up within 30 days then every 3-6 months until 4 years following registration
I To establish and confirm the safety and dose of iberdomide as maintenance after idecabtagene vicleucel ide-cel CAR-T Safety run-in II To assess whether iberdomide maintenance therapy after idecabtagene vicleucel CAR-T cell therapy increases progression-free survival PFS relative to observation without additional therapy Randomized phase II
SECONDARY OBJECTIVES
I To demonstrate anti-tumor activity defined as conversion from non-minimal residual disease MRD complete response CRstringent CR sCR status to MRD-negative CRsCR as well as improvement in PFS in the safety run-in cohort Safety run-in II To estimate the rate of conversion from MRD-positive at baseline to MRD-negative at any time point post-initiation of iberdomide maintenance or observation without additional therapy Key secondary objective Randomized phase II III To estimate overall survival OS distribution post-initiation of iberdomide maintenance or observation without additional therapy Key secondary objective Randomized phase II IV To estimate the minimal residual disease MRD-negativity rate at pre-registration and at one year post-initiation of iberdomide maintenance or observation without additional therapy Randomized phase II V To estimate rate of deepening hematological response among patients with measurable multiple myeloma MM post-initiation of iberdomide maintenance or observation without additional therapy Randomized phase II VI To evaluate the safety profile of iberdomide maintenance Randomized phase II VII To evaluate the peripheral blood immunophenotype before and during iberdomide maintenance or observation without additional therapy Randomized phase II VIII To evaluate persistence of CAR-T cells with iberdomide maintenance or observation without additional therapy Randomized phase II
CORRELATIVE SCIENCE OBJECTIVES
I To estimate the minimal residual disease MRD-negativity rate at start of maintenance and at one year post-initiation of maintenance or observation
II To estimate the sustained MRD-negativity rate III To estimate the rate of conversion from MRD-positive to MRD-negative Key objective IV To evaluate the peripheral blood immunophenotype before and during maintenance therapy or observation
V To evaluate the persistence of CAR-T cells VI To evaluate B-cell maturation antigen BCMA protein expression by immunohistochemistry on myeloma cells from patients that have relapsedrecurrent disease
OUTLINE Patients are randomized to 1 of 2 groups
GROUP 1 Patients undergo disease monitoring at monthly clinic visits until disease progression Patients also undergo bone marrow aspiration and biopsy throughout the trial undergo collection of blood samples at screening and on study and undergo positron emission tomography PETcomputed tomography CT andor skeletal survey x-ray CT or magnetic resonance imaging MRI at screening and then as clinically indicated
GROUP 2 Patients receive iberdomide orally PO once daily QD on days 1-21 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo bone marrow aspiration and biopsy throughout the trial undergo collection of blood samples at screening and on study and undergo PETCT andor skeletal survey x-ray CT or MRI at screening and then as clinically indicated
After completion of study treatment patients are followed up within 30 days then every 3-6 months until 4 years following registration
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-10541 | REGISTRY | None | None |
| A062102 | OTHER | None | None |
| A062102 | OTHER | None | None |
| U10CA180821 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180821 |