Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Lenalidomide Type: Drug
Name: Dexamethasone Type: Drug
Name: Elotuzumab (BMS-901608) Type: Biological
Overall Status
Recruiting
Summary
The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- Newly diagnosed with symptomatic Multiple Myeloma (MM)

- Have not received any prior systemic anti-myeloma therapy

- Have measurable disease

- Are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-116 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Exclusion Criteria:

- Non-secretory or oligo-secretory or free light-chain only myeloma

- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

- Monoclonal Gammopathy of Undetermined Significance (MGUS)

- Active plasma cell leukemia

- Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Locations
Local Institution
Nagoya-shi, Aichi, Japan
Status: Recruiting
Contact: Site 0013
Local Institution
Nagoya-shi, Aichi, Japan
Status: Recruiting
Contact: Site 0014
Local Institution
Aomori-shi, Aomori, Japan
Status: Recruiting
Contact: Site 0020
Local Institution
Chiba-shi, Chiba, Japan
Status: Recruiting
Contact: Site 0006
Local Institution
Kamogawa-shi, Chiba, Japan
Status: Recruiting
Contact: Site 0023
Local Institution
Fukuoka-shi, Fukuoka, Japan
Status: Recruiting
Contact: Site 0018
Local Institution
Maebashi-shi, Gunma, Japan
Status: Recruiting
Contact: Site 0003
Local Institution
Shibukawa-shi, Gunma, Japan
Status: Recruiting
Contact: Site 0004
Local Institution
Morioka-shi, Iwate, Japan
Status: Recruiting
Contact: Site 0001
Local Institution
Kagoshima-shi, Kagoshima, Japan
Status: Recruiting
Contact: Site 0021
Local Institution
Kyoto-shi, Kyoto, Japan
Status: Recruiting
Contact: Site 0015
Local Institution
Sendai, Miyagi, Japan
Status: Recruiting
Contact: Site 0002
Local Institution
Niigata-shi, Niigata, Japan
Status: Recruiting
Contact: Site 0012
Local Institution
Okayama-shi, Okayama, Japan
Status: Recruiting
Contact: Site 0017
Local Institution
Osaka-shi, Osaka, Japan
Status: Recruiting
Contact: Site 0016
Local Institution
Kawagoe-shi, Saitama, Japan
Status: Recruiting
Contact: Site 0005
Local Institution
Hamamatsu-shi, Shizuoka, Japan
Status: Not yet recruiting
Contact: Site 0024
Local Institution
Bunkyo-ku, Tokyo, Japan
Status: Recruiting
Contact: Site 0009
Local Institution
Koto-ku, Tokyo, Japan
Status: Not yet recruiting
Contact: Site 0011
Local Institution
Shibuya-ku, Tokyo, Japan
Status: Recruiting
Contact: Site 0010
Local Institution
Shinjuku-Ku, Tokyo, Japan
Status: Recruiting
Contact: Site 0007
Local Institution
Shinjuku-ku, Tokyo, Japan
Status: Recruiting
Contact: Site 0022
Local Institution
Tachikawa-shi, Tokyo, Japan
Status: Recruiting
Contact: Site 0008
Local Institution
Osaka, Japan
Status: Recruiting
Contact: Site 0019
Start Date
January 2015
Completion Date
September 2018
Sponsors
Bristol-Myers Squibb
Source
Bristol-Myers Squibb
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page