Clinical trial NCT02272803: Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
Official title: A Phase 2, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2014-10-23
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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 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

Primary outcomes:
measure: Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)
timeFrame: From first dose until documented response (assessed up to February 2017, approximately 24 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From first dose until documented response, up to approximately 72 months
measure: Progression Free Survival (PFS)
timeFrame: From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months
measure: Progression Free Survival (PFS) Rate
timeFrame: From randomization up to the specified timepoints, up to 3 years
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Aomori-shi
country: Japan
facility: Local Institution
state: Aomori
city: Chiba-shi
country: Japan
facility: Local Institution
state: Chiba
city: Kamogawa-shi
country: Japan
facility: Local Institution
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Local Institution
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Local Institution
state: Gunma
city: Shibukawa-shi
country: Japan
facility: Local Institution
state: Gunma
city: Fukuyama-shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Morioka-shi
country: Japan
facility: Local Institution
state: Iwate
city: Kagoshima-shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Kyoto-shi
country: Japan
facility: Local Institution
state: Kyoto
city: Sendai
country: Japan
facility: Local Institution
state: Miyagi
city: Niigata-shi
country: Japan
facility: Local Institution
state: Niigata
city: Okayama-shi
country: Japan
facility: Local Institution
state: Okayama
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Kawagoe-shi
country: Japan
facility: Local Institution
state: Saitama
city: Hamamatsu-shi
country: Japan
facility: Local Institution
state: Shizuoka
city: Utsunomiya-shi
country: Japan
facility: Local Institution
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Koto-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Tachikawa-shi
country: Japan
facility: Local Institution
state: Tokyo
city: Kasama-shi
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Suzuki A, Kakugawa S, Miyoshi M, Hori M, Suzuki K, Furukawa Y, Ohta K. Soluble SLAMF7 is a predictive biomarker for elotuzumab therapy. Leukemia. 2020 Nov;34(11):3088-3090. doi: 10.1038/s41375-020-0860-7. Epub 2020 May 12. No abstract available.