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

Tracking Information

First Received Date ^ICMJE

November 6, 2007

Last Updated Date

June 2, 2009

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

DLT [ Time Frame: first cycle (28 days) ]

Change History

Complete list of historical versions of study NCT00555100 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Efficacy (M-protein) [ Time Frame: 24 weeks ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Multiple Myeloma

Intervention ^ICMJE

Drug: lenalidomide
Drug: dexamethasone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2011

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00555100

Responsible Party

Joseph Melillo/ President of Celgene KK, Celgene KK

Study ID Numbers ^ICMJE

CC-5013-MM-017

Study Sponsor ^ICMJE

Celgene Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Masaaki Takatoku, M.D.

Celgene K.K.

Information Provided By

Celgene Corporation

Verification Date

June 2009

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