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Monoclonal Antibodies
B: Elotuzumab + Lenalidomide at 10 mg for Multiple Myeloma
Phase 2
Waitlist Available
Led By Melissa Alsina, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
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 an average of 8 months
Awards & highlights
Study Summary
This trial will study how well elotuzumab plus lenalidomide works in treating patients with myeloma who have had a relapse.
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ an average of 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 8 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With Progression Free Survival (PFS)
Secondary outcome measures
Minimum Response (MR)
Overall Response
Trial Design
2Treatment groups
Active Control
Group I: B: Elotuzumab + Lenalidomide at 10 mgActive Control3 Interventions
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
Group II: A: Elotuzumab + Lenalidomide at 25 mgActive Control3 Interventions
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab.
Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
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Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,464 Total Patients Enrolled
29 Trials studying Multiple Myeloma
2,095 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,046 Total Patients Enrolled
87 Trials studying Multiple Myeloma
29,902 Patients Enrolled for Multiple Myeloma
Melissa Alsina, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
5 Previous Clinical Trials
150 Total Patients Enrolled
5 Trials studying Multiple Myeloma
150 Patients Enrolled for Multiple Myeloma
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