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Phase I Trial of Everolimus, Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

NCT01889420 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2015-07-31

Study results available
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Summary

This study is being conducted to test the possibility that a combination of three drugs, pomalidomide and everolimus with dexamethasone, may improve patient responses when compared with use of either drug alone, with dexamethasone in refractory/relapsed multiple myeloma.

Conditions

  • Multiple Myeloma in Relapse

Interventions

DRUG

Combination therapy

Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone. Cycles will span 28 days. Dosage schedules will be: 1. Everolimus daily for 28 days of a 28 day cycle; 2. Pomalidomide daily for 21 days of a 28 day cycle 3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Ian Rabinowitz, MD · University of New Mexico Cancer Center

  • Ducinea D Quintana, MD · University of New Mexico Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-06-30
Completion
2015-07-31

Countries

  • United States

Study Locations

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Entities

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 NCT01889420 on ClinicalTrials.gov