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

Sponsor

Celgene (Industry)

Overall Status

Completed

CT.gov ID

NCT00065351

Collaborator

(none)

222

Enrollment

Locations

Arm

Actual Duration (Months)

8.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: CC-5013	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

222 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 1, 2003

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 CC-5013 - oral - 30mg daily on days 1-21 every 28 days	Drug: CC-5013 CC-5013 - oral - 30mg daily on days 1-21 every 28 days

Arm

Intervention/Treatment

Experimental: 1

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

Drug: CC-5013

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

Outcome Measures

Primary Outcome Measures

Myeloma response [randomization to progression]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Verde Hematology Oncology	Glendale	Arizona	United States	85304
2	Mayo Clinic	Scottsdale	Arizona	United States	85259
3	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States	94704
4	Providence St. Joseph Medical Center/Cancer Center	Burbank	California	United States	91505
5	Wilshire Oncology Medical Group, Inc.	La Verne	California	United States	91750
6	Institute for Myeloma and Bone	Los Angeles	California	United States	90067
7	Cancer Care Associates	Redondo Beach	California	United States	90277
8	Mayo Clinic	Jacksonville	Florida	United States	32224
9	Northwest Georgia Oncology Centers	Marietta	Georgia	United States	30060
10	Atlanta Cancer Care-Roswell	Roswell	Georgia	United States	30076
11	Northwestern University Med Ctr	Chicago	Illinois	United States	60611-2927
12	Midwest Cancer Research Group	Skokie	Illinois	United States	60077
13	University of Maryland Medical Center	Baltimore	Maryland	United States	21201-1595
14	Center for Cancer and Blood Disorders	Bethesda	Maryland	United States	20717
15	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
16	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
17	University of Massachusetts	Worcester	Massachusetts	United States	01655
18	Mayo Clinic	Rochester	Minnesota	United States	55902
19	Nevada Cancer Center	Las Vegas	Nevada	United States	89109
20	SUNY Health Science Center at Brooklyn	Brooklyn	New York	United States	11203
21	St. Vincent's Comprehensive Cancer Center	New York	New York	United States	10011
22	Carolina Hematology-Oncology Associates	Charlotte	North Carolina	United States	28203
23	Cleveland Clinic Myeloma Program Hematology & Medical Oncology /R35	Cleveland	Ohio	United States	44195
24	Western Pennsylvania Cancer Institute	Pittsburgh	Pennsylvania	United States	15224
25	Swedish Cancer Institute	Seattle	Washington	United States	98104
26	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024