A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.
Overview
- Phase
- Phase 1
- Intervention
- Elotuzumab (HuLuc63)
- Conditions
- Multiple Myeloma
- Sponsor
- Abbott
- Enrollment
- 28
- Locations
- 8
- Primary Endpoint
- Identify the maximum tolerated dose of elotuzumab in combination with bortezomib (phase 1).
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV) infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of bortezomib at 1.3 mg/m^2 IV bolus. Bortezomib will be given in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period). Elotuzumab will be administered as a separate infusion within 30 minutes following bortezomib administration on the same days as the first and last dose of each bortezomib cycle (i.e., Days 1 and 11).
Detailed Description
The phase 2 portion of this study was not initiated because a decision was made to conduct a phase 2 randomized clinical trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1
2.5 mg/kg
Intervention: Elotuzumab (HuLuc63)
Cohort 2
5.0 mg/kg
Intervention: Elotuzumab (HuLuc63)
Cohort 3
10.0 mg/kg
Intervention: Elotuzumab (HuLuc63)
Cohort 4
20.0 mg/kg
Intervention: Elotuzumab (HuLuc63)
Outcomes
Primary Outcomes
Identify the maximum tolerated dose of elotuzumab in combination with bortezomib (phase 1).
Time Frame: First cycle of treatment.
The highest dose level of elotuzumab at which \<= 1 dose-limiting toxicity occurs in 6 subjects
Evaluate the efficacy of elotuzumab in combination with bortezomib (phase 2).
Time Frame: Screening to the 30 day follow up visit.
Objective response rate (complete and partial response) according to European Group for Blood and Marrow Transplantation (EBMT) criteria
Secondary Outcomes
- Evaluate the efficacy of elotuzumab in combination with bortezomib (phase 1).(Screening to the 30 day follow up visit.)
- Evaluate the immunogenicity of elotuzumab in combination with bortezomib (phase 1 and 2).(Screening to the 30 day follow up visit.)
- Evaluate the pharmacodynamics of elotuzumab in combination with bortezomib (phase 1 and 2).(Screening to the 30 day follow up visit.)
- Evaluate the pharmacokinetic parameters of elotuzumab in combination with bortezomib (phase 1 and 2)(Screening to the 30 day follow up visit.)
- Evaluate the safety of elotuzumab in combination with bortezomib (phase 1 and 2).(Screening to the 30 day follow up visit.)