Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776395
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2021-02-11
Brief Title:
Iberdomide Alone or in Combination with Dexamethasone for the Treatment of Intermediate- or High-Risk Smoldering Multiple Myeloma
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Iberdomide in Intermediate- and High-Risk Smoldering Myeloma SMM Patients a Phase 2 Study with a Safety Run-in
Status:
RECRUITING
Status Verified Date:
2024-09
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 studies the effects of iberdomide when given alone or in combination with dexamethasone in treating intermediate or high-risk smoldering multiple myeloma patients Immunotherapy with iberdomide may induce changes in bodys immune system and may interfere with the ability of cancer cells to grow and spread Dexamethasone is a synthetic steroid similar to steroid hormones produced naturally in the adrenal gland and is used with other drugs in the treatment of some types of cancer Giving iberdomide with dexamethasone my improve time to progression to symptomatic myeloma with improved tolerability
Detailed Description:
PRIMARY OBJECTIVE
I To determine the overall response rate ORR of iberdomide hydrochloride iberdomide and iberdomide with dexamethasone in intermediate- and high-risk smoldering multiple myeloma SMM
SECONDARY OBJECTIVES
I To determine the 1- and 2- year progression free survival rates of patients receiving iberdomide with and without dexamethasone in intermediate-risk and high-risk smoldering myeloma
II To determine the time to progression and overall survival of patients with intermediate- and high-risk smoldering myeloma receiving iberdomide with and without dexamethasone
III To study the risk of adverse hematologic and non-hematologic events observed in patients receiving iberdomide with and without dexamethasone for treatment of intermediate- and high-risk smoldering myeloma
IV To evaluate stem cell mobilization failure and early stem cell mobilization feasibility
TERTIARYEXPLORATORY OBJECTIVES
I To assess the effects of iberdomide on cereblon targets Aiolos and Ikaros in natural killer NK- and T- cells
II To measure the effect of iberdomide with and without dexamethasone on T-cell and NK-cell counts and activation
III To determine the prognostic impact of high-risk cytogenetic abnormalities on clinical outcomes
IV To assess minimal residual disease MRD on bone marrow samples in subjects who achieved a complete response CR or better and evaluate the correlation between MRD status and clinical outcome measures
V To assess the association between anti-tumor activity and immune cells in tumor and blood
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive iberdomide hydrochloride orally PO once daily QD on days 1-21 and dexamethasone PO on days 1 8 15 and 22 Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity Patients then receive iberdomide hydrochloride PO QD on days 1-21 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM B Patients receive iberdomide hydrochloride PO QD on days 1-21 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 4 weeks and then every 6 months thereafter
I To determine the overall response rate ORR of iberdomide hydrochloride iberdomide and iberdomide with dexamethasone in intermediate- and high-risk smoldering multiple myeloma SMM
SECONDARY OBJECTIVES
I To determine the 1- and 2- year progression free survival rates of patients receiving iberdomide with and without dexamethasone in intermediate-risk and high-risk smoldering myeloma
II To determine the time to progression and overall survival of patients with intermediate- and high-risk smoldering myeloma receiving iberdomide with and without dexamethasone
III To study the risk of adverse hematologic and non-hematologic events observed in patients receiving iberdomide with and without dexamethasone for treatment of intermediate- and high-risk smoldering myeloma
IV To evaluate stem cell mobilization failure and early stem cell mobilization feasibility
TERTIARYEXPLORATORY OBJECTIVES
I To assess the effects of iberdomide on cereblon targets Aiolos and Ikaros in natural killer NK- and T- cells
II To measure the effect of iberdomide with and without dexamethasone on T-cell and NK-cell counts and activation
III To determine the prognostic impact of high-risk cytogenetic abnormalities on clinical outcomes
IV To assess minimal residual disease MRD on bone marrow samples in subjects who achieved a complete response CR or better and evaluate the correlation between MRD status and clinical outcome measures
V To assess the association between anti-tumor activity and immune cells in tumor and blood
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive iberdomide hydrochloride orally PO once daily QD on days 1-21 and dexamethasone PO on days 1 8 15 and 22 Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity Patients then receive iberdomide hydrochloride PO QD on days 1-21 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM B Patients receive iberdomide hydrochloride PO QD on days 1-21 Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 4 weeks and then every 6 months thereafter
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 |
|---|---|---|---|
| P30CA138292 | NIH | Emory University HospitalWinship Cancer Institute | httpsreporternihgovquickSearchP30CA138292 |
| NCI-2020-08351 | REGISTRY | None | None |
| WINSHIP5157-20 | OTHER | None | None |