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Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide

NCT03411031 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-03-29

Study results available
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Summary

The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.

Conditions

Interventions

DRUG

Elotuzumab

Elotuzumab according to dosing schedule outlined in treatment arms.

DRUG

Lenalidomide

Lenalidomide according to dosing schedule outlined in treatment arms.

DRUG

Dexamethasone

Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Melissa Alsina, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-04
Primary Completion
2021-02-18
Completion
2021-11-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03411031 on ClinicalTrials.gov