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Pomalidomide in Gene Expression Profiling (GEP)-Defined High-risk Multiple Myeloma

NCT01177735 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2021-04-22

Study results available
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Summary

This is a phase II study, open-label, single institution trial of pomalidomide in GEP-defined, high-risk relapsing/refractory multiple myeloma. Prior therapy must have included lenalidomide. Patient accrual is 30 over a 2 year period.

Primary objective:

* To determine progression-free survival (PFS) after initiation of pomalidomide therapy

Secondary objective:

* To determine the response rate (CR, n-CR, VGPR) and duration of response after pomalidomide therapy.
* To determine gene expression profiling (GEP) changes exerted within 48 hours of initiation of daily pomalidomide dosing.
* To determine gene expression profiling (GEP) changes exerted within 48 hours of initiation 3 concurrent days of exposure to lenalidomide.
* To determine MRI- and PET-CT-defined CR in studies obtained at baseline and every 6 month examinations.

Conditions

Interventions

DRUG

Pomalidomide

Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Saad Usmani, MD · University of Arkansas for Medical Sciences, Myeloma Institute for Research and Therapy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-09-30
Completion
2013-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01177735 on ClinicalTrials.gov