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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02272803
Other study ID # CA204-116
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 20, 2015
Est. completion date July 21, 2021

Study information

Verified date May 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date July 21, 2021
Est. primary completion date February 9, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lenalidomide

Dexamethasone

Biological:
Elotuzumab (BMS-901608)


Locations

Country Name City State
Japan Local Institution Aomori-shi Aomori
Japan Local Institution Bunkyo-ku Tokyo
Japan Local Institution Chiba-shi Chiba
Japan Local Institution Fukuoka-shi Fukuoka
Japan Local Institution Fukuyama-shi Hiroshima
Japan Local Institution Hamamatsu-shi Shizuoka
Japan Local Institution Kagoshima-shi Kagoshima
Japan Local Institution Kamogawa-shi Chiba
Japan Local Institution Kasama-shi
Japan Local Institution Kawagoe-shi Saitama
Japan Local Institution Koto-ku Tokyo
Japan Local Institution Kyoto-shi Kyoto
Japan Local Institution Maebashi-shi Gunma
Japan Local Institution Matsuyama-shi Ehime
Japan Local Institution Morioka-shi Iwate
Japan Local Institution Nagoya-shi Aichi
Japan Local Institution Nagoya-shi Aichi
Japan Local Institution Niigata-shi Niigata
Japan Local Institution Okayama-shi Okayama
Japan Local Institution Osaka-shi Osaka
Japan Local Institution Osaka-shi Osaka
Japan Local Institution Sendai Miyagi
Japan Local Institution Shibukawa-shi Gunma
Japan Local Institution Shibuya-ku Tokyo
Japan Local Institution Shinjuku-Ku Tokyo
Japan Local Institution Shinjuku-ku Tokyo
Japan Local Institution Tachikawa-shi Tokyo
Japan Local Institution Utsunomiya-shi Tochigi

Sponsors (2)

Lead Sponsor Collaborator
Bristol-Myers Squibb AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld) ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.
SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and = 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or = 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: = 50% reduction of serum M-Protein and reduction in urinary M-protein by = 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a = 50% reduction in the size of soft tissue plasmacytomas is also required.
From first dose until documented response (assessed up to February 2017, approximately 24 months)
Secondary Objective Response Rate (ORR) ORR is the percentage of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) as determined by investigator using the International Myeloma Working Group (IMWG) response criteria.
SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and = 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or = 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: = 50% reduction of serum M-Protein and reduction in urinary M-protein by = 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a = 50% reduction in the size of soft tissue plasmacytomas is also required.
From first dose until documented response, up to approximately 72 months
Secondary Progression Free Survival (PFS) PFS is defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression. From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months
Secondary Progression Free Survival (PFS) Rate PFS rate is defined as the percentage of participants who have neither progressed nor died at the specified timepoints From randomization up to the specified timepoints, up to 3 years
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