NCT00044018

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_2 multiple-myeloma

Timeline
Completed

Started Apr 2002

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2007

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

2.7 years

First QC Date

August 16, 2002

Last Update Submit

November 7, 2019

Conditions

Multiple Myeloma

Keywords

RevimidCC5013

Outcome Measures

Primary Outcomes (1)

  • Confirmed M-Protein Response During Single Agent CDC-501 Therapy

    M-Protein response evaluated every 4 weeks through urine and serum electrophoresis.

    Response assessed every 4 weeks; up to 62 months

Interventions

CDC-501DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

H Lee Moffit Cancer Center

Tampa, Florida, 33612, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

St Vincent's Cancer Center

New York, New York, 10011, United States

Location

Related Publications (1)

  • Richardson PG, Blood E, Mitsiades CS, Jagannath S, Zeldenrust SR, Alsina M, Schlossman RL, Rajkumar SV, Desikan KR, Hideshima T, Munshi NC, Kelly-Colson K, Doss D, McKenney ML, Gorelik S, Warren D, Freeman A, Rich R, Wu A, Olesnyckyj M, Wride K, Dalton WS, Zeldis J, Knight R, Weller E, Anderson KC. A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma. Blood. 2006 Nov 15;108(10):3458-64. doi: 10.1182/blood-2006-04-015909. Epub 2006 Jul 13.

    PMID: 16840727BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Robert Knight, MD

    Celgene Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2002

First Posted

August 20, 2002

Study Start

April 1, 2002

Primary Completion

December 1, 2004

Study Completion

February 15, 2007

Last Updated

November 12, 2019

Record last verified: 2019-11

Locations

US(4)