Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065351
• Other study ID #: CC-5013-MM-014
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2003
• Est. completion date: March 1, 2007

Study information

• Verified date: November 2019
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: March 1, 2007
• Est. primary completion date: October 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• CC-5013
CC-5013 - oral - 30mg daily on days 1-21 every 28 days

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	SUNY Health Science Center at Brooklyn	Brooklyn	New York
United States	Providence St. Joseph Medical Center/Cancer Center	Burbank	California
United States	Carolina Hematology-Oncology Associates	Charlotte	North Carolina
United States	Northwestern University Med Ctr	Chicago	Illinois
United States	Cleveland Clinic Myeloma Program Hematology & Medical Oncology /R35	Cleveland	Ohio
United States	Palo Verde Hematology Oncology	Glendale	Arizona
United States	Mayo Clinic	Jacksonville	Florida
United States	Wilshire Oncology Medical Group, Inc.	La Verne	California
United States	Nevada Cancer Center	Las Vegas	Nevada
United States	Institute for Myeloma and Bone	Los Angeles	California
United States	Northwest Georgia Oncology Centers	Marietta	Georgia
United States	St. Vincent's Comprehensive Cancer Center	New York	New York
United States	Western Pennsylvania Cancer Institute	Pittsburgh	Pennsylvania
United States	Cancer Care Associates	Redondo Beach	California
United States	Mayo Clinic	Rochester	Minnesota
United States	Atlanta Cancer Care-Roswell	Roswell	Georgia
United States	Mayo Clinic	Scottsdale	Arizona
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Midwest Cancer Research Group	Skokie	Illinois
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myeloma response		randomization to progression
Secondary	Time to tumor progression		randomization to progression
Secondary	Duration of response		randomization to progression
Secondary	Survival (1-year and overall survival)		1 year and ongoing
Secondary	Time to first skeletal-related event (SRE) (clinical need for radiation or surgery to bone)		randomization to progression
Secondary	Safety (type, frequency, severity, and relationship of adverse events to study drug)		ongoing