CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma - Tabular View

Tracking Information

First Received Date ^ICMJE

August 16, 2002

Last Updated Date

September 22, 2009

Start Date ^ICMJE

April 2002

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00044018 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma

Official Title ^ICMJE

An Open-Label Study to Evaluate the Efficacy and Safety of Two CDC-501 Dose Regimens When Used Alone or in Combination With Dexamethasone for the Treatment Relapsed or Refractory Multiple Myeloma

Brief Summary

The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Drug: CDC-501

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

102

Completion Date

December 2004

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Subject must be diagnosed with multiple myeloma (with measurable M-Protein in serum and/or urine), and be considered to have disease progression after at least two cycles of treatment or have relapsed after treatment.
Subject must understand and voluntarily sign an informed consent document.
Subject must not have received corticosteroids, other chemotherapy, thalidomide, or other investigational agents, within 21 days of baseline
ECOG (Zubrod) performance status of 0 to 2.
Subject must be able to adhere to the study visit schedule and other protocol requirements.
Women of childbearing potential (WCBP ) must have a negative serum or urine pregnancy test within 7 days of baseline. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00044018

Responsible Party

Robert Knight MD - VP Hematology, Celgene Corporation

Study ID Numbers ^ICMJE

CC-5013-MM-007

Study Sponsor ^ICMJE

Celgene Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Robert Knight, MD

Celgene Corporation

Information Provided By

Celgene Corporation

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP