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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00555100
First received: November 6, 2007
Last updated: January 26, 2011
Last verified: January 2011
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

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 ]

Enrollment: 15
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555100

Locations
Japan
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
Investigators
Study Director: Masaaki Takatoku, M.D. Celgene K.K.
  More Information

No publications provided

Responsible Party: Joseph Melillo/ President of Celgene KK, Celgene KK
ClinicalTrials.gov Identifier: NCT00555100     History of Changes
Other Study ID Numbers: CC-5013-MM-017
Study First Received: November 6, 2007
Last Updated: January 26, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on November 27, 2014