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CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

NCT00091260 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2017-02-20

Study results available
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Summary

RATIONALE: Drugs such as CC-5013 and dexamethasone may be effective in treating primary systemic amyloidosis.

PURPOSE: This phase II trial is studying CC-5013 to see how well it works with or without dexamethasone in treating patients with primary systemic amyloidosis.

Conditions

Interventions

DRUG

dexamethasone

dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.

DRUG

lenalidomide

15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Vaishali Sanchorawala

    lead OTHER

Principal Investigators

  • David C. Seldin, MD, PhD · Boston Medical 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
2004-01-31
Primary Completion
2012-07-31
Completion
2015-05-31

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 NCT00091260 on ClinicalTrials.gov