NCT03000634

2015-09: a Phase II Randomized, Open-label Study of Anti-signaling Lymphocytic Activation Molecule Monoclonal Antibody During Maintenance Therapy

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Elotuzumab	Administered through a small tube that goes directly into the vein
DRUG	Bortezomib	Administered as a subcutaneous injection under the skin
DRUG	Lenalidomide	Capsule taken by mouth
DRUG	Dexamethasone	Taken by mouth

Timeline

• Start date: 2017-04-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2016-12-22
• Last updated: 2024-09-05

Regulatory

• FDA-regulated drug study