A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00424047
• Date of registration: 17/01/2007
• Prospective Registration: No
• Primary sponsor: Celgene
• Public title: A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
• Scientific title: 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.
• Date of first enrolment: January 1, 2003
• Target sample size: 351
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00424047
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, France, Germany, Greece, Ireland, Israel, Italy, Poland, Spain, Sweden, Switzerland, Ukraine, United Kingdom

Contacts

• Name: Robert Knight, MD
• Affiliation: Celgene Corporation

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Myeloma

Intervention(s)

Drug: CC-5013 plus dexamethasone

Drug: Dexamethasone plus Placebo

Primary Outcome(s)

Kaplan-Meier Estimate of Time to Tumor Progression (TTP) [Time Frame: From randomization up to cut-off date of 03 August 2005; up to 24 months]

Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008) [Time Frame: From randomization up to cut-off date of 02 March 2008; up to 51 months]

Secondary Outcome(s)

Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008) [Time Frame: Randomization to data cut-off of 02 Mar 2008; up to 51 months]

Kaplan-Meier Estimate of Overall Survival (OS) [Time Frame: Randomization to data cut off of 03 August 2005; up to 24 months]

Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008) [Time Frame: Randomization to cut off date of 02 March 2008; up to 51 months]

Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008) [Time Frame: Randomization to data cut off of 02 March 2008; up to 51 months]

Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone) [Time Frame: Up to unblinding data cut off of 03 August 2005; up to 24 months]

Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale [Time Frame: Randomization to cut off date of 03 August 2005; up to 24 months]

Number of Participants With Adverse Events (AE) [Time Frame: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months]

Summary of Myeloma Response Rates Based on Best Response Assessment [Time Frame: Randomization to 03 August 2005; up to 24 months]

Secondary ID(s)

CC-5013-MM-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00424047