- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00044018
CDC-501 Therapy in Relapsed or Refractory Multiple Myeloma
November 7, 2019 updated by: Celgene
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
The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.
Study Overview
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- H Lee Moffit Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
-
Minnesota
-
Rochester, Minnesota, United States, 55902
- Mayo Clinic
-
-
New York
-
New York, New York, United States, 10011
- St Vincent's Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Confirmed M-Protein Response During Single Agent CDC-501 Therapy
Time Frame: Response assessed every 4 weeks; up to 62 months
|
M-Protein response evaluated every 4 weeks through urine and serum electrophoresis.
|
Response assessed every 4 weeks; up to 62 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2002
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
February 15, 2007
Study Registration Dates
First Submitted
August 16, 2002
First Submitted That Met QC Criteria
August 19, 2002
First Posted (Estimate)
August 20, 2002
Study Record Updates
Last Update Posted (Actual)
November 12, 2019
Last Update Submitted That Met QC Criteria
November 7, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- CC-5013-MM-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
-
Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
-
National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
-
Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on CDC-501
-
Chong Kun Dang PharmaceuticalCompletedType 2 Diabetes MellitusKorea, Republic of
-
Chong Kun Dang PharmaceuticalCompletedDiabetes Mellitus, Type 2Korea, Republic of
-
Chong Kun Dang PharmaceuticalCompletedType 2 DiabetesKorea, Republic of
-
National Cancer Institute (NCI)CompletedNeurofibromatosis Type 1 | Recurrent Childhood Pilocytic Astrocytoma | Recurrent Childhood Visual Pathway GliomaUnited States, Canada, Australia, New Zealand
-
Okayama UniversityTranslational Research Center for Medical Innovation, Kobe, Hyogo, JapanCompletedDilated CardiomyopathyJapan
-
Fox Chase Cancer CenterKnowledge NetworksCompleted
-
Bellicum PharmaceuticalsActive, not recruitingLymphoma | Myelodysplastic Syndromes | Acute Lymphoblastic Leukemia | Acute Myelogenous LeukemiaUnited States
-
Otsuka Pharmaceutical Co., Ltd.CompletedAcute Myeloid LeukemiaJapan
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSecondary Acute Myeloid Leukemia | Alkylating Agent-Related Acute Myeloid LeukemiaUnited States
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedAcute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome | Adult Acute Myeloid Leukemia in RemissionUnited States