Multiple Myeloma
Conditions
Keywords
Revimid, CC5013
Brief summary
The purpose of the study is to select the dose regimen of CDC-501 that provides the most promising evidence of efficacy.
Interventions
DRUGCDC-501
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Confirmed M-Protein Response During Single Agent CDC-501 Therapy | Response assessed every 4 weeks; up to 62 months | M-Protein response evaluated every 4 weeks through urine and serum electrophoresis. |
Countries
United States
Outcome results
None listed