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A Study of DVd +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)
This study is ongoing, but not recruiting participants.
First Received: September 13, 2004   Last Updated: December 19, 2006   History of Changes
Sponsored by: Celgene Corporation
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00091624
  Purpose

A Phase I Study of CC-5013 in combination with Doxil, Vincristine and Decadron (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma


Condition Intervention Phase
Multiple Myeloma
Drug: CC-5013
Phase I

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study
Official Title: A Phase I Study of DVd +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)

Further study details as provided by Celgene Corporation:

Estimated Enrollment: 40
Study Start Date: March 2003
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Age greater than 18 years at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Diagnosed with active multiple myeloma and be considered to have disease progression after at least 2 cycles of anti-myeloma treatment or have relapsed with progressive disease after treatment.
  • Measurable myeloma paraprotein levels in serum (≥ 0.5g/dL) or urine (≥ 0.2 g excreted in a 24-hour collection sample).
  • Eastern Cooperative Group (ECOG) Performance Status of 0-2. Performance status of 3 and 4 will be allowed if related to bony disease.
  • Bilirubin < 2 x upper limits of normal (ULN).
  • Liver enzymes (ALT or AST) < 3 x ULN.
  • Must have adequate bone marrow function: * Absolute neutrophil count > 1,000 cells/mm3 (1.0 x 109/L) * Platelets ≥ 100,000 cells/mm3 (100 x 109/L) * Hemoglobin ≥ 8 g/dL
  • Must have adequate renal function: creatinine ≤ 2.5 mg/dL.
  • Must have 2-d echocardiogram indicating LVEF ≥ 50% within 42 days prior to first dose of study drug.
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. 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. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.

Exclusion Criteria:

  • Severe infection requiring intravenous antibiotic treatment.
  • Life expectancy of less than 3 months.
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years.
  • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
  • Subjects who have received > 500mg/m2 of doxorubicin alone, or Doxil® alone, or doxorubicin plus Doxil®.
  • Prior treatment with CC-5013.
  • Prior development of ≥ grade 2 (NCI CTC) allergic reaction/hypersensitivity while taking thalidomide.
  • Prior development of a ≥ grade 3 (NCI CTC) rash or any desquamation while taking thalidomide.
  • History of cardiac disease, with New York Heart Association Class II or greater.
  • Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma.
  • Any investigational agent or systemic anti-myeloma therapy within 28 days of the first dose of treatment.
  • 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091624

Locations
United States, Ohio
Cleveland Clinic Myeloma Program
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Celgene Corporation
  More Information

No publications provided

Study ID Numbers: CC-5013-MM-011
Study First Received: September 13, 2004
Last Updated: December 19, 2006
ClinicalTrials.gov Identifier: NCT00091624     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
CC-5013
CC5013
Revlimid
Lenalidomide
Multiple myeloma

Study placed in the following topic categories:
Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Lenalidomide
Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Lenalidomide
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 06, 2009