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

Celgene

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: lenalidomide

Drug: dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00555100

CC-5013-MM-017

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.