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Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma

NCT00065351 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2019-11-12

No results posted yet for this study

Summary

For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline.

Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter.

Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.

Conditions

Interventions

DRUG

CC-5013

CC-5013 - oral - 30mg daily on days 1-21 every 28 days

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Robert Knight, MD · Celgene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-01
Primary Completion
2006-10-01
Completion
2007-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00065351 on ClinicalTrials.gov