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

Multiple Myeloma Clinical Trial

Official title:

A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056160
• Other study ID #: CC-5013-MM-009
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2003
• Last updated: September 18, 2017
• Start date: January 1, 2003
• Est. completion date: October 1, 2008

Study information

• Verified date: September 2017
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: October 1, 2008
• Est. primary completion date: November 1, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• CC-5013
Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide 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.
• Dexamethasone
Subjects in the CC-5013/Dex and Placebo/Dex 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.

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Hospital Charles LeMoyne	Greenfield Park	Quebec
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	McGill University	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	University Of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Johns Hopkins Medicine Department of Oncology	Baltimore	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Charleston Hematology/Oncology P.A.	Charleston	South Carolina
United States	Medical University of SC	Charleston	South Carolina
United States	Northwestern University Med Ctr	Chicago	Illinois
United States	Rush Cancer Institute Section of Hematology	Chicago	Illinois
United States	Cleveland Clinic Myeloma Program	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope National Medical Center	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Clinical Research Consultants, Inc.	Hoover	Alabama
United States	MD Anderson Cancer Center	Houston	Texas
United States	Indiana Cancer Research Institute	Indianapolis	Indiana
United States	University of Iowa Hospital Clinic	Iowa City	Iowa
United States	Mayo Clinic- Jacksonville	Jacksonville	Florida
United States	UCLA School of Medicine	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Miami	Miami	Florida
United States	Froedtert Hospital/BMT Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Ocshner Clinical Foundation	New Orleans	Louisiana
United States	New York Presbyterian Hospital	New York	New York
United States	St. Vincent's Comprehensive Cancer Center	New York	New York
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Kaiser Permanente Northwest Region Center for Health Research	Portland	Oregon
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Washington University School of Medicine- Sherman Cancer Center	Saint Louis	Missouri
United States	UCSF California	San Francisco	California
United States	Oncology Hematology Consultants	Sarasota	Florida
United States	Stanford University Medical Center, Division of Hematology	Stanford	California
United States	SUNY Upstate Medical University	Syracuse	New York
United States	H Lee Moffitt Cancer Center	Tampa	Florida
United States	MBCCOP Our Lady of Mercy Cancer Center New York Medical College	The Bronx	New York
United States	South Carolina Oncology Group	West Columbia	South Carolina
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Tumor Progression (TTP)	Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.	60 weeks (median Time To Progression of CC-5013/Dex treatment group)
Secondary	Overall Survival	Overall survival was calculated as the time from randomization to death from any cause.	170 weeks (median overall survival of CC-5013/Dex treatment group)
Secondary	Myeloma Response	The overall confirmed response that was maintained for =6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.	Up to Unblinding (07 Jun 2005)
Secondary	Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)	The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.	30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)

External Links

•   Link to CSR synopsis