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The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma.


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to tumor progression (TTP)

Outcome Description:

Time from randomization to the first documentation of progressive disease based on the Myeloma response determination criteria developed by Bladé et al 1998

Outcome Time Frame:

Up to 23 months

Safety Issue:

No

Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-MM-010

NCT ID:

NCT00424047

Start Date:

January 2003

Completion Date:

December 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Celgene
  • Revlimid
  • CC-5013
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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