Back to resultsCDC-501 Therapy in Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CDC-501
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Revimid, CC5013
Eligibility Criteria
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.
Sites / Locations
- H Lee Moffit Cancer Center
- Dana-Farber Cancer Institute
- Mayo Clinic
- St Vincent's Cancer Center
Outcomes
Primary Outcome Measures
Confirmed M-Protein Response During Single Agent CDC-501 Therapy
M-Protein response evaluated every 4 weeks through urine and serum electrophoresis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00044018
Brief Title
CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2002 (Actual)
Primary Completion Date
December 1, 2004 (Actual)
Study Completion Date
February 15, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Revimid, CC5013
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CDC-501
Primary Outcome Measure Information:
Title
Confirmed M-Protein Response During Single Agent CDC-501 Therapy
Description
M-Protein response evaluated every 4 weeks through urine and serum electrophoresis.
Time Frame
Response assessed every 4 weeks; up to 62 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Knight, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
H Lee Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
St Vincent's Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16840727
Citation
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.
Results Reference
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Learn more about this trial
CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma
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