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Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00555100
Recruitment Status : Completed
First Posted : November 7, 2007
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):
Celgene Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Drug: lenalidomide Drug: dexamethasone Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2007
Primary Completion Date : December 2010
Study Completion Date : December 2010

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.

Primary Outcome Measures :
  1. DLT [ Time Frame: first cycle (28 days) ]

Secondary Outcome Measures :
  1. Efficacy (M-protein) [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555100

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

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00555100     History of Changes
Other Study ID Numbers: CC-5013-MM-017
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents