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

November 6, 2007
January 26, 2011
July 2007
December 2010   (final data collection date for primary outcome measure)
DLT [ Time Frame: first cycle (28 days) ] [ Designated as safety issue: Yes ]
DLT [ Time Frame: first cycle (28 days) ]
Complete list of historical versions of study NCT00555100 on ClinicalTrials.gov Archive Site
Efficacy (M-protein) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Efficacy (M-protein) [ Time Frame: 24 weeks ]
Not Provided
Not Provided
 
Safety Study of Lenalidomide With and Without Dexamethasone in Japanese Subjects With Previously Treated Multiple Myeloma
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

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00555100
CC-5013-MM-017
Yes
Joseph Melillo/ President of Celgene KK, Celgene KK
Celgene Corporation
Not Provided
Study Director: Masaaki Takatoku, M.D. Celgene K.K.
Celgene Corporation
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP