Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT03713294
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2018-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dexamethasone, Elotuzumab, and Pomalidomide in Treating Patients With Refractory Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Phase II Trial of Sequential Treatment of Multiple Myeloma With Antibody Therapy
Status:
COMPLETED
Status Verified Date:
2024-11
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 how well dexamethasone, elotuzumab, pomalidomide work in treating patients with multiple myeloma that has not responded to previous treatment. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as elotuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pomalidomide may stop the growth of multiple myeloma by blocking the growth of new blood vessels necessary for tumor growth. Giving dexamethasone, elotuzumab, pomalidomide may work better in treating patients with multiple myeloma.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the overall response rate (ORR) of utilizing elotuzumab, pomalidomide and dexamethasone in patients with disease refractory to daratumumab.
SECONDARY OBJECTIVES:
I. To determine percentage of patients achieving complete response (CR) with the elotuzumab combination.
II. To determine progression-free survival (PFS) for treatment with the elotuzumab combination.
III. To determine safety profile for treatment with the elotuzumab combination. IV. To determine the overall survival (OS) for patients receiving treatment with the elotuzumab combination.
OUTLINE:
Patients receive dexamethasone intravenously (IV) on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and orally (PO) on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO 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 every 3 months until progressive disease, then every 6 months thereafter.
I. To determine the overall response rate (ORR) of utilizing elotuzumab, pomalidomide and dexamethasone in patients with disease refractory to daratumumab.
SECONDARY OBJECTIVES:
I. To determine percentage of patients achieving complete response (CR) with the elotuzumab combination.
II. To determine progression-free survival (PFS) for treatment with the elotuzumab combination.
III. To determine safety profile for treatment with the elotuzumab combination. IV. To determine the overall survival (OS) for patients receiving treatment with the elotuzumab combination.
OUTLINE:
Patients receive dexamethasone intravenously (IV) on days 1, 8, 15, and 22 of cycles 1-2 and IV on day 1 and orally (PO) on days 8, 15, and 22 of subsequent cycles and elotuzumab IV on days 1, 8, 15, and 22 of cycles 1-2 and day 1 of subsequent cycles. Patients also receive pomalidomide PO 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 every 3 months until progressive disease, then every 6 months thereafter.
Study Oversight
Has Oversight DMC:
True
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?: