Status:
COMPLETED
Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
AbbVie
Conditions:
Multiple Myeloma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- Non-secretory 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
Key Trial Info
Start Date :
February 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT02272803
Start Date
February 20 2015
End Date
July 21 2021
Last Update
June 22 2022
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution
Nagoya, Aichi-ken, Japan, 4600001
2
Local Institution
Nagoya, Aichi-ken, Japan, 4678602
3
Local Institution
Aomori, Aomori, Japan, 0308553
4
Local Institution
Chiba, Chiba, Japan, 2608677