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

NCT03000634 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-09-05

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Faith E Davies, MD · University of Arkansas for Medical Science-Myeloma Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2017-04-01
Completion
2017-04-01
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03000634 on ClinicalTrials.gov