Anti-CXCR4 (BMS-936564) Alone and in Combination With Lenalidomide/Dexamethasone or Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma
NCT ID: NCT01359657
Last Updated: 2016-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2011-09-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Anti-CXCR4 (BMS-936564)+Lenalidomide+Dexamethasone
Anti-CXCR4 (BMS-936564)
Solution, Intravenously, 1-10 mg/kg, Single 60 minute infusion once a week, 42 days (cycle 1) 28 days subsequent cycles
Lenalidomide
Tablets, per os (by mouth route of administration) (P.O), 25 mg, daily for 21 days (Day 15-35 in cycle 1; Day 1-21 in subsequent cycles), no dosing in Cycle 1, Cycle 2 +:daily dosing from Day 1-21
Dexamethasone
Tablets, per os (by mouth route of administration) (P.O), 40 mg, administered with Lenalidomide once every 7 days, 42 days (cycle 1) 28 days subsequent cycles
Arm B: Anti-CXCR4 (BMS-936564)+Bortezomib+Dexamethasone
Anti-CXCR4 (BMS-936564)
Solution, Intravenously, 1-10 mg/kg, Single 60 minute infusion once a week, 35 days (cycle 1) 21 days subsequent cycles
Bortezomib
Intravenous (IV), 1.3 mg/m2, administered on day 15, 18, 22, 25 in cycle 1, then on Day 1, 4, 8, 11 in subsequent cycles, no dosing in Cycle 1, Cycle 2 +:dosing on Day 1, 4, 8, 11
Dexamethasone
Tablets, per os (by mouth route of administration) (P.O), 40 mg, administered on the day of (and the day after) Bortezomib infusion, 35 days (cycle 1) 21 days subsequent cycles
Interventions
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Anti-CXCR4 (BMS-936564)
Solution, Intravenously, 1-10 mg/kg, Single 60 minute infusion once a week, 42 days (cycle 1) 28 days subsequent cycles
Lenalidomide
Tablets, per os (by mouth route of administration) (P.O), 25 mg, daily for 21 days (Day 15-35 in cycle 1; Day 1-21 in subsequent cycles), no dosing in Cycle 1, Cycle 2 +:daily dosing from Day 1-21
Dexamethasone
Tablets, per os (by mouth route of administration) (P.O), 40 mg, administered with Lenalidomide once every 7 days, 42 days (cycle 1) 28 days subsequent cycles
Anti-CXCR4 (BMS-936564)
Solution, Intravenously, 1-10 mg/kg, Single 60 minute infusion once a week, 35 days (cycle 1) 21 days subsequent cycles
Bortezomib
Intravenous (IV), 1.3 mg/m2, administered on day 15, 18, 22, 25 in cycle 1, then on Day 1, 4, 8, 11 in subsequent cycles, no dosing in Cycle 1, Cycle 2 +:dosing on Day 1, 4, 8, 11
Dexamethasone
Tablets, per os (by mouth route of administration) (P.O), 40 mg, administered on the day of (and the day after) Bortezomib infusion, 35 days (cycle 1) 21 days subsequent cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Disease must be assessed within 28 days prior to treatment initiation.
* Subjects must have evidence of relapsed or relapsed/refractory disease.
* Subjects must have received at least 2 prior regimens for multiple myeloma.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2.
* Subjects must have received last treatment (ie, chemotherapy, radiotherapy, biological, immunotherapy or investigational agent \[therapeutic or diagnostic\]) at least 14 days prior to treatment initiation. The last treatment of systemically absorbed steroids must be at least 2 weeks or 5 half lives (whichever is shorter) before the first dose of BMS-936564.
Exclusion Criteria
* Current or recent (within 3 months) gastrointestinal disease or condition that could impact the absorption of orally-administered drug.
* Inability to swallow oral medication.
* Uncontrolled or significant heart disease.
* Any other malignancy, excluding basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, localized prostate cancer, or superficial bladder cancer stage 0, from which the subject has not been disease-free for at least 3 years.
18 Years
ALL
No
Sponsors
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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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H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
University Of Kansas Cancer Center And Medical Pavillion
Westwood, Kansas, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
University Of Washington School Of Medicine
Seattle, Washington, United States
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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CA212-002
Identifier Type: -
Identifier Source: org_study_id
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