Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
NCT ID: NCT02272803
Last Updated: 2022-06-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2015-02-20
2021-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
Drug: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Drug: Dexamethasone
Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Tablets, Oral, 40 mg, once daily, on Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Biological: Elotuzumab (BMS-901608)
Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Lenalidomide
Dexamethasone
Elotuzumab (BMS-901608)
Arm B: Lenalidomide + Dexamethasone
Drug: Lenalidomide
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Drug: Dexamethasone
Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Lenalidomide
Dexamethasone
Interventions
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Lenalidomide
Dexamethasone
Elotuzumab (BMS-901608)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Aomori, Aomori, Japan
Local Institution
Chiba, Chiba, Japan
Local Institution
Kamogawa-shi, Chiba, Japan
Local Institution
Matsuyama, Ehime, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Maebashi, Gunma, Japan
Local Institution
Shibukawa-shi, Gunma, Japan
Local Institution
Fukuyama-shi, Hiroshima, Japan
Local Institution
Morioka, Iwate, Japan
Local Institution
Kagoshima, Kagoshima-ken, Japan
Local Institution
Kyoto, Kyoto, Japan
Local Institution
Sendai, Miyagi, Japan
Local Institution
Niigata, Niigata, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Kawagoe-shi, Saitama, Japan
Local Institution
Hamamatsu, Shizuoka, Japan
Local Institution
Utsunomiya, Tochigi, Japan
Local Institution
Bunkyo-ku, Tokyo, Japan
Local Institution
Koto-ku, Tokyo, 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
Kasama-shi, , Japan
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA204-116
Identifier Type: -
Identifier Source: org_study_id
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