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

November 7, 2019 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Multiple Myeloma

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Niigata, Japan
    - Niigata Cancer Center Hospital
  - Tokyo, Japan
    - Keio University Hospital
- Aichi
  - Nagoya, Aichi, Japan
    - National Hospital Organization Nagoya Medical Center
  - Nagoya, Aichi, Japan
    - Nagoya City University Hospital
- Tochigi
  - Shimotsuke, Tochigi, Japan
    - Jichi Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
DLT Time Frame: first cycle (28 days)	first cycle (28 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy (M-protein) Time Frame: 24 weeks	24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Iida S, Chou T, Okamoto S, Nagai H, Hatake K, Murakami H, Takagi T, Shimizu K, Lau H, Takeshita K, Takatoku M, Hotta T. Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol. 2010 Jul;92(1):118-26. doi: 10.1007/s12185-010-0624-7. Epub 2010 Jun 18. Erratum In: Int J Hematol. 2010 Jul;92(1):127-8.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)