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

Phase 1

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00555100
• Lead Sponsor: Celgene

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

Not available

Study Timeline

• Study Start: 2007-07-01
• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-06
• Study First Posted: 2007-11-07
• Primary Completion: 2010-12-01
• Study Completion: 2010-12-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
DLT	first cycle (28 days)

Secondary Outcome Measures

Name	Time	Method
Efficacy (M-protein)	24 weeks

Trial Locations

Locations (5)

Keio University Hospital; 🇯🇵 Tokyo, Japan

Niigata Cancer Center Hospital; 🇯🇵 Niigata, Japan

National Hospital Organization Nagoya Medical Center; 🇯🇵 Nagoya, Aichi, Japan

Jichi Medical University Hospital; 🇯🇵 Shimotsuke, Tochigi, Japan

Nagoya City University Hospital; 🇯🇵 Nagoya, Aichi, Japan