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Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma

NCT01159574 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2019-06-11

Study results available
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Summary

This study is intended to investigate the combination of the combination of dexamethasone (Decadron®), Clarithromycin (Biaxin®), and pomalidomide (CC-4047®) \[ClaPd\] in multiple myeloma patients who have relapsed or refractory disease who have failed prior treatment with lenalidomide when used alone or in combination with corticosteroids. Primary endpoint will be response rate to treatment. Secondary endpoints will include toxicity of the combination, time to maximum response, and time to disease progression

Conditions

Interventions

DRUG

dexamethasone

40mg will be given on days 1, 8, 15, 22 of a 28-day cycle

DRUG

clarithromycin

orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle

DRUG

Pomalidomide

orally 4mg daily for days 1-21 of each 28 day cycle

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Ruben Niesvizky, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-05-05
Completion
2015-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT01159574 on ClinicalTrials.gov