Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan
A Phase 2, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma in Japan
1 other identifier
interventional
82
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 multiple-myeloma
Started Feb 2015
Typical duration for phase_2 multiple-myeloma
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2014
CompletedFirst Posted
Study publicly available on registry
October 23, 2014
CompletedStudy Start
First participant enrolled
February 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2017
CompletedResults Posted
Study results publicly available
March 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2021
CompletedJune 22, 2022
May 1, 2022
2 years
October 21, 2014
January 26, 2018
May 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Objective Response Rate (ORR)
From first dose until documented response, up to approximately 72 months
Progression Free Survival (PFS)
From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months
Progression Free Survival (PFS) Rate
From randomization up to the specified timepoints, up to 3 years
Study Arms (2)
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
EXPERIMENTALDrug: 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
Arm B: Lenalidomide + Dexamethasone
ACTIVE COMPARATORDrug: 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- AbbViecollaborator
Study Sites (28)
Local Institution
Nagoya, Aichi-ken, 4600001, Japan
Local Institution
Nagoya, Aichi-ken, 4678602, Japan
Local Institution
Aomori, Aomori, 0308553, Japan
Local Institution
Chiba, Chiba, 2608677, Japan
Local Institution
Kamogawa-shi, Chiba, 2968602, Japan
Local Institution
Matsuyama, Ehime, 7900024, Japan
Local Institution
Fukuoka, Fukuoka, 8128582, Japan
Local Institution
Maebashi, Gunma, 3718511, Japan
Local Institution
Shibukawa-shi, Gunma, 3770280, Japan
Local Institution
Fukuyama-shi, Hiroshima, 7200001, Japan
Local Institution
Morioka, Iwate, 0208505, Japan
Local Institution
Kagoshima, Kagoshima-ken, 8920853, Japan
Local Institution
Kyoto, Kyoto, 6028566, Japan
Local Institution
Sendai, Miyagi, 9808574, Japan
Local Institution
Niigata, Niigata, 9518566, Japan
Local Institution
Okayama, Okayama-ken, 7011192, Japan
Local Institution
Osaka, Osaka, 5300012, Japan
Local Institution
Osaka, Osaka, 5438555, Japan
Local Institution
Kawagoe-shi, Saitama, 3508550, Japan
Local Institution
Hamamatsu, Shizuoka, 4313192, Japan
Local Institution
Utsunomiya, Tochigi, 3200834, Japan
Local Institution
Bunkyo-ku, Tokyo, 1138677, Japan
Local Institution
Koto-ku, Tokyo, 1358550, Japan
Local Institution
Shibuya-ku, Tokyo, 1508935, Japan
Local Institution
Shinjuku-Ku, Tokyo, 1608582, Japan
Local Institution
Shinjuku-ku, Tokyo, 1628655, Japan
Local Institution
Tachikawa-shi, Tokyo, 1900014, Japan
Local Institution
Kasama-shi, 3091793, Japan
Related Publications (1)
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.
PMID: 32398792DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2014
First Posted
October 23, 2014
Study Start
February 20, 2015
Primary Completion
February 9, 2017
Study Completion
July 21, 2021
Last Updated
June 22, 2022
Results First Posted
March 22, 2018
Record last verified: 2022-05