A Study of 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 plus Placebo; Drug: CC-5013 plus dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424047

CC-5013-MM-010

Details and patient eligibility

About

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 refractory multiple myeloma."

Enrollment: 351 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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351 participants in 2 patient groups

CC-5013 plus dexamethasone

Experimental group

Description:

Arm A: Oral CC-5013 is initiated on Day 1 of Cycle 1 at a dose of 25 mg daily for 21 days every 28 days. Therefore, the subject will take a placebo identical in appearance to the CC-5013 capsule for week 4 of every 28 days. Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral CC-5013 placebo capsules will be administered for 28 days of every cycle.

Treatment:

Drug: CC-5013 plus dexamethasone

Dexamethasone plus placebo

Experimental group

Description:

Arm B: Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.

Treatment:

Drug: Dexamethasone plus Placebo