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

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:	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:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Lenalidomide CC 5013 Dexamethasone Sodium Phosphate

U.S. FDA Resources

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:

10mg-25mg PO/day,day1-day21 of each 28day cycle. Number of Cycles:until progression or unacceptable toxicity develops.

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
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan
Nagoya City University Hospital
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
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate

Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on February 09, 2012