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Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
This study is ongoing, but not recruiting participants.
First Received: November 6, 2007   Last Updated: June 2, 2009   History of Changes
Sponsor: Celgene Corporation
Information provided by: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00555100
  Purpose

CC-5013-MM-017 is a Phase I, multicenter study to determine the maximum tolerated dose (MTD), safety profile, pharmacokinetics, and preliminary efficacy of lenalidomide with and without dexamethasone in Japanese subjects with previously treated MM. The study will consist of two cohorts: 1) Monotherapy "Maximum Tolerated Dose (MTD) Determination" Cohort; and 2) "Combination Treatment" Cohort.


Condition Intervention Phase
Multiple Myeloma
Drug: lenalidomide
Drug: dexamethasone
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety Study
Official Title: A Multicenter, Phase I Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Efficacy of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • DLT [ Time Frame: first cycle (28 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy (M-protein) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: July 2007
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: lenalidomide
    10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
    Drug: dexamethasone
    40mg PO/day, day1-4,9-12,17-20 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with previously treated multiple myeloma
  • Measurable levels of m-protein in serum >= 0.5 g/dL [5g/L]) or urine (>= 0.2 g excreted in a 24-hour collection sample)
  • ECOG performance status of 0 - 2
  • Willing to follow pregnancy precautions

Exclusion Criteria:

  • Patients with acute an myocardial infarction (MI) within the past 6 months, or patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 3 years
  • Patients with tuberculous diseases, herpes simplex keratitis, systemic mycosis or other active infectious diseases
  • Patients with non-controlled diabetes, hypertension, digestive ulcer or glaucoma
  • Patients with posterior subcapsular cataracts
  • Patients with mental illness
  • Patients with past histories or complications which make the Investigator or other staff member deem them inappropriate for this study
  • Pregnant or lactating females
  • Grade 2 or worse neuropathy
  • Any of the following laboratory abnormalities:

Absolute neutrophil count (ANC) < 1,000cells/mL Platelet count < 75,000/mL Serum creatinine > 2.5 mg/dL Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)

  • Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for >= 3 years. - Patients who received radiation therapy within 14 days of the start of study drug
  • Patients with scars from a recent viscus operation
  • Patients with history of a desquamating (blistering) rash while taking thalidomide
  • Patients with prior use of lenalidomide
  • Patients with known HIV positivity.
  • Patients who used cytotoxic chemotherapeutic agents, immunomodulating agents, or other experimental agents (agents that are not commercially available) intended for the treatment of MM within 28 days of the start of lenalidomide therapy.
  • Patients with known history of hypersensitivity to dexamethasone.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555100

Locations
Japan
Niigata Cancer Center Hospital
Niigata, Japan
Keio University Hospital
Tokyo, Japan
Japan, Aichi
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan
Nagoya City University Hospital
Nagoya, Aichi, Japan
Japan, Tochigi
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Masaaki Takatoku, M.D. Celgene K.K.
  More Information

No publications provided

Responsible Party: Celgene KK ( Joseph Melillo/ President of Celgene KK )
Study ID Numbers: CC-5013-MM-017
Study First Received: November 6, 2007
Last Updated: June 2, 2009
ClinicalTrials.gov Identifier: NCT00555100     History of Changes
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Dexamethasone acetate
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Vascular Diseases
Lenalidomide
Gastrointestinal Agents
Glucocorticoids
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010