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An Open-Label Study to Evaluate the Efficacy and Safety of Two CDC-501 Dose Regimens When Used Alone or in Combination With Dexamethasone for the Treatment Relapsed or Refractory Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

An Open-Label Study to Evaluate the Efficacy and Safety of Two CDC-501 Dose Regimens When Used Alone or in Combination With Dexamethasone for the Treatment Relapsed or Refractory Multiple Myeloma

Inclusion Criteria


- Subject must be diagnosed with multiple myeloma (with measurable M-Protein in serum
and/or urine), and be considered to have disease progression after at least two
cycles of treatment or have relapsed after treatment.

- Subject must understand and voluntarily sign an informed consent document.

- Subject must not have received corticosteroids, other chemotherapy, thalidomide, or
other investigational agents, within 21 days of baseline

- ECOG (Zubrod) performance status of 0 to 2.

- Subject must be 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 baseline. In addition, 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.

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Robert Knight, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-MM-007

NCT ID:

NCT00044018

Start Date:

April 2002

Completion Date:

December 2004

Related Keywords:

  • Multiple Myeloma
  • Revimid
  • CC5013
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Mayo ClinicRochester, Minnesota  55905
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
H Lee Moffit Cancer CenterTampa, Florida  33612
St Vincent's Cancer CenterNew York, New York  10011