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

Celgene

Status and phase: Completed; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Drug: CC-5013

Study type: Interventional

Funder types: Industry

Identifiers

NCT00056160

CC-5013-MM-009

Details and patient eligibility

About

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

Full description

This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

Enrollment: 353 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
• No more than 3 previous anti-myeloma regimens
• No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
• Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).

Exclusion criteria

• Prior development of disease progression during high-dose dexamethasone containing therapy.
• Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed
• Laboratory abnormalities: Platelet count less than 75,000/mm cubed
• Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL
• Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT])greater than 3.0 x upper limit of normal
• Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL
• Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.
• Known hypersensitivity to thalidomide or dexamethasone.
• Development of a desquamating rash while taking thalidomide.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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353 participants in 2 patient groups

CC-5013/Dex

Experimental group

Description:

CC-5013 (lenalidomide) plus oral high-dose dexamethasone

Treatment:

Drug: CC-5013

Drug: Dexamethasone

Placebo/Dex

Experimental group

Description:

Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

Treatment:

Drug: Dexamethasone