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Monoclonal Antibodies
Arm 1: Elotuzumab + Lirilumab for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during treatment and first 100 days after treatment
Awards & highlights
No Placebo-Only Group
Summary
To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma.
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during treatment and first 100 days after treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during treatment and first 100 days after treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety as measured by the rate of AEs, SAEs, deaths is the primary endpoint of this Phase 1 study. All subjects who receive at least one (full or partial) dose of Elotuzumab, Lirilumab or Urelumab will be evaluated for safety
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: Elotuzumab + UrelumabExperimental Treatment2 Interventions
Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response
Group II: Arm 1: Elotuzumab + LirilumabExperimental Treatment2 Interventions
Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lirilumab
Not yet FDA approved
Urelumab
Not yet FDA approved
Elotuzumab
FDA approved
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Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,688 Previous Clinical Trials
4,096,763 Total Patients Enrolled
91 Trials studying Multiple Myeloma
22,370 Patients Enrolled for Multiple Myeloma
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