Status:
COMPLETED
A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Lead Sponsor:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refr...
Eligibility Criteria
Inclusion
- Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
- Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2
- Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
Exclusion
- Prior development of disease progression during high-dose dexamethasone containing therapy
- Pregnant or lactating females
- The development of a desquamating rash while taking thalidomide
- Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
- Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3
- Laboratory abnormalities: Platelet count \< 75,000/mm3
- Laboratory abnormalities: Serum creatinine \> 2.5 mg/dL
- Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine aminotransferase (ALT) \> 3.0 x upper limit of normal
- Laboratory abnormalities: Serum total bilirubin \> 2.0 mg/dL
- Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for ≥ 3 years.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2013
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT00424047
Start Date
January 1 2003
End Date
November 12 2013
Last Update
October 19 2017
Active Locations (69)
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1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
2
Peter MacCallum Cancer Centre Divsion of Haematology/Medical Oncology
East Melbourne, Victoria, Australia, 3006
3
The Alfred Hospital
Prahran, Victoria, Australia, 3121
4
Border Medical Oncology
Wodonga, Victoria, Australia, 3690