Clinical trial NCT00065351: Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
Official title: A Multicenter, Open-label Study to Determine the Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
CC-5013
Revlimid
MM
CC5013
relapsed and refractory multiple myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2003-07-23
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline.

Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter.

Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.


Eligibility criteria: Inclusion Criteria:

* Understand and voluntarily sign an informed consent form.
* Age greater than or equal to 18 years at the time of signing the informed consent form.
* Must have a diagnosis of multiple myeloma and have relapsed and refractory disease. Such subjects have relapsed after having had at least a partial myeloma paraprotein response (greater or equal to 50% reduction of myeloma paraprotein) to prior therapy and then continued to develop disease progression despite salvage anti-myeloma therapy. Subjects must have documented evidence of disease progression during therapy with the last prior anti-myeloma treatment regimen (must have received at least 2 cycles) prior to study enrollment.Subjects may have been previously treated with thalidomide and/or radiation therapy.
* Measurable levels of myeloma paraprotein in serum (greater or equal to 0.5 g/dL) or urine (greater or equal to 0.2 g excreted in a 24-hour collection sample).
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (see Appendix II).
* Able to adhere to the study visit schedule and other protocol requirements
* Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.

Exclusion Criteria:

* Sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.
* WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days for women with irregular cycles) and 4 weeks after the last dose of study drug.
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
* Pregnant or lactating females.
* Any of the following laboratory abnormalities:

A) Absolute neutrophil count (ANC) \<1,000 cells/mm\^3 (1.0 x 10\^9/L) B) Platelet count \<75,000/mm\^3 (75 x 10\^9/L) C) Serum creatinine \>2.5 mg/dL (221 umol/L) D) Serum SGOT/AST or SGPT/ALT \>3.0 x upper limit of normal (ULN) E) Serum total bilirubin \>2.0 mg/dL (34 umol/L)

* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
* Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for greater than or equal to 3 years.
* Prior greater than or equal to grade 3 allergic reaction/hypersensitivity to thalidomide.
* Prior greater than or equal to grade 3 rash or any desquamating (blistering) rash while taking thalidomide.
* Prior use of CC-5013.
* Use of any standard/experimental anti-myeloma drug therapy within 28 days of the initiation of study drug therapy or use of any experimental non-drug therapy within 56 days of the initiation of study drug therapy

Primary outcomes:
measure: Myeloma response
timeFrame: randomization to progression
Secondary outcomes:
measure: Time to tumor progression
timeFrame: randomization to progression
measure: Duration of response
timeFrame: randomization to progression
measure: Survival (1-year and overall survival)
timeFrame: 1 year and ongoing
measure: Time to first skeletal-related event (SRE) (clinical need for radiation or surgery to bone)
timeFrame: randomization to progression
measure: Safety (type, frequency, severity, and relationship of adverse events to study drug)
timeFrame: ongoing
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Palo Verde Hematology Oncology
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center/Cancer Center
state: California
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group, Inc.
state: California
city: Los Angeles
country: United States
facility: Institute for Myeloma and Bone
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers
state: Georgia
city: Roswell
country: United States
facility: Atlanta Cancer Care-Roswell
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Med Ctr
state: Illinois
city: Skokie
country: United States
facility: Midwest Cancer Research Group
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: Brooklyn
country: United States
facility: SUNY Health Science Center at Brooklyn
state: New York
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: Charlotte
country: United States
facility: Carolina Hematology-Oncology Associates
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Myeloma Program Hematology & Medical Oncology /R35
state: Ohio
city: Pittsburgh
country: United States
facility: Western Pennsylvania Cancer Institute
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Celgene
name: Robert Knight, MD
role: STUDY_DIRECTOR
References:
citation: Richardson P, Jagannath S, Hussein M, Berenson J, Singhal S, Irwin D, Williams SF, Bensinger W, Badros AZ, Vescio R, Kenvin L, Yu Z, Olesnyckyj M, Zeldis J, Knight R, Anderson KC. Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma. Blood. 2009 Jul 23;114(4):772-8. doi: 10.1182/blood-2008-12-196238. Epub 2009 May 26.