Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-03 @ 12:02 AM
Study NCT ID:
NCT03000634
Status:
WITHDRAWN
Last Update Posted:
2024-09-05
First Post:
2016-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
2015-09: a Phase II Randomized, Open-label Study of Anti-signaling Lymphocytic Activation Molecule Monoclonal Antibody During Maintenance Therapy
Sponsor:
University of Arkansas
Organization:
Study Overview
Official Title:
2015-09: a Phase II Randomized, Open-label Study of Anti-SLAMF7 MAb During Maintenance Therapy Versus Standard Maintenance Therapy in Gene Expression Profiling (GEP)- Defined Low Risk Multiple Myeloma Patients with High Risk Cytogenetic Abnormalities
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not and will not be initiated due to lack of funding.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the effectiveness and safety of maintenance therapy with continuous bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.
Detailed Description:
Past studies conducted at the Myeloma Institute have shown that many patients with low-risk disease (as determined by gene array studies - studies that look at specific genes using special equipment) respond very well to treatment. However, about 15% of low-risk patients still relapse during the first three years of treatment, which means that better treatments are still needed.
This study will compare the effectiveness and safety of maintenance therapy with continuous bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.
Elotuzumab, bortezomib, lenalidomide and dexamethasone are all approved by the FDA for the treatment of patients with multiple myeloma. VRD is the standard maintenance regimen prescribed at the University of Arkansas for Medical Sciences (UAMS) Myeloma Institute for patients with low risk disease. The investigators want to learn if alternating VRD with Elo RD during maintenance therapy will result in better outcomes.
This study will compare the effectiveness and safety of maintenance therapy with continuous bortezomib, lenalidomide, and dexamethasone (VRD) compared to maintenance therapy that alternates VRD with Elotuzumab, lenalidomide, and dexamethasone (Elo RD) every eight weeks.
Elotuzumab, bortezomib, lenalidomide and dexamethasone are all approved by the FDA for the treatment of patients with multiple myeloma. VRD is the standard maintenance regimen prescribed at the University of Arkansas for Medical Sciences (UAMS) Myeloma Institute for patients with low risk disease. The investigators want to learn if alternating VRD with Elo RD during maintenance therapy will result in better outcomes.
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?:
False
Is an FDA AA801 Violation?: