Ignite Creation Date:
2024-07-17 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465316
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-17
Brief Title:
Testing Teclistamab TECVAYLI in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1b Trial of Teclistamab in Combination With Iberdomide for RelapsedRefractory 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:
This phase Ib trial tests the safety side effects and best dose of iberdomide in combination with teclistamab in treating multiple myeloma that has come back after a period of improvement relapsed or that does not respond to treatment refractory Iberdomide is a medication that belongs to a group of drugs known as cereblon E3 ligase modulators Iberdomide works by targeting and destroying proteins that help myeloma cancer cells to survive A monoclonal antibody is a type of protein that can bind to certain targets in the body such as molecules that cause the body to make an immune response antigens Immunotherapy with monoclonal antibodies such as teclistamab may help the bodys immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread Giving iberdomide in combination with teclistamab may be safe and tolerable in treating patients with relapsed or refractory multiple myeloma
Detailed Description:
PRIMARY OBJECTIVE
I Estimate the recommended phase 2 dose RP2D of iberdomide in combination with teclistamab
SECONDARY OBJECTIVES
I To evaluate the safety and toxicity profile of iberdomide in combination with teclistamab
II To observe and record antitumor activity
CORRELATIVE OBJECTIVES
I To evaluate the changes in the tumor immune microenvironment exhausted T-cell phenotypes percent T regulatory cells T regs T-cell activation in peripheral blood and bone marrow caused by the addition of iberdomide to teclistamab and how they relate to minimal residual disease MRD status responses rates and survival outcomes
II To evaluate soluble B-cell maturation antigen sBCMA levels at baseline and how they correlate to response rates and survival outcomes in patients treated with teclistamab plus iberdomide
III To identify the immunophenotypic and transcriptomic characterization of malignant plasma cells that are resistant to teclistamab and iberdomide
OUTLINE This is a dose-escalation study of iberdomide in combination with teclistamab
Patients receive teclistamab subcutaneously SC on days 1 4 7 15 and 22 for cycle 1 and days 1 8 15 and 22 for subsequent cycles Patients also receive iberdomide orally PO once daily QD on days 1-21 for cycle 2 and beyond Cycles repeat every 28 days for up to 4 years in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood and urine sample collection bone marrow aspiration and biopsy and computed tomography CT positron emission tomography PETCT or magnetic resonance imaging MRI throughout the trial
After completion of study treatment patients are followed up every 3-6 months for up to 2 years
I Estimate the recommended phase 2 dose RP2D of iberdomide in combination with teclistamab
SECONDARY OBJECTIVES
I To evaluate the safety and toxicity profile of iberdomide in combination with teclistamab
II To observe and record antitumor activity
CORRELATIVE OBJECTIVES
I To evaluate the changes in the tumor immune microenvironment exhausted T-cell phenotypes percent T regulatory cells T regs T-cell activation in peripheral blood and bone marrow caused by the addition of iberdomide to teclistamab and how they relate to minimal residual disease MRD status responses rates and survival outcomes
II To evaluate soluble B-cell maturation antigen sBCMA levels at baseline and how they correlate to response rates and survival outcomes in patients treated with teclistamab plus iberdomide
III To identify the immunophenotypic and transcriptomic characterization of malignant plasma cells that are resistant to teclistamab and iberdomide
OUTLINE This is a dose-escalation study of iberdomide in combination with teclistamab
Patients receive teclistamab subcutaneously SC on days 1 4 7 15 and 22 for cycle 1 and days 1 8 15 and 22 for subsequent cycles Patients also receive iberdomide orally PO once daily QD on days 1-21 for cycle 2 and beyond Cycles repeat every 28 days for up to 4 years in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood and urine sample collection bone marrow aspiration and biopsy and computed tomography CT positron emission tomography PETCT or magnetic resonance imaging MRI throughout the trial
After completion of study treatment patients are followed up every 3-6 months for up to 2 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04754 | REGISTRY | None | None |
| 10620 | OTHER | None | None |
| 10620 | OTHER | None | None |
| UM1CA186709 | NIH | None | None |