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

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

Genetics Home Reference related topics:

aceruloplasminemia hemophilia

MedlinePlus related topics:

Multiple Myeloma

ChemIDplus related topics:

Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study

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

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 ]

Estimated Enrollment:	15
Study Start Date:	July 2007
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	October 2008 (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
	Niigata Cancer Center Hospital
	Niigata, Japan
	Keio University Hospital
	Tokyo, Japan

Japan, Aichi
	National Hospital Organization Nagoya Medical Center
	Nagoya, Aichi, Japan
	Nagoya City University Hospital
	Nagoya, Aichi, Japan

Japan, Tochigi
	Jichi Medical University Hospital
	Shimotsuke, Tochigi, Japan

Sponsors and Collaborators

Celgene Corporation

Investigators


Study Director:	Masaaki Takatoku, M.D.	Celgene K.K.

More Information

Responsible Party:	Celgene KK ( Joseph Melillo/ President of Celgene KK )
Study ID Numbers:	CC-5013-MM-017
First Received:	November 6, 2007
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00555100
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:

Dexamethasone

Immunoproliferative Disorders

Hematologic Diseases

Blood Coagulation Disorders

Lenalidomide

Vascular Diseases

Paraproteinemias

Hemostatic Disorders

Multiple Myeloma

Hemorrhagic Disorders

Multiple myeloma

Lymphoproliferative Disorders

Dexamethasone acetate

Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Neoplasms by Histologic Type

Antineoplastic Agents, Hormonal

Immune System Diseases

Antineoplastic Agents

Blood Protein Disorders

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Gastrointestinal Agents

Antiemetics

Hormones

Glucocorticoids

Pharmacologic Actions

Neoplasms

Autonomic Agents

Therapeutic Uses

Cardiovascular Diseases

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2008

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00555100