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A Multicenter, Open-label Study to Determine the Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

A Multicenter, Open-label Study to Determine the Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma

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

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Myeloma response

Outcome Time Frame:

randomization to progression

Safety Issue:


Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:




Start Date:

July 2003

Completion Date:

March 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • CC-5013
  • Revlimid
  • MM
  • CC5013
  • relapsed and refractory multiple myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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