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.
- Registration Number
- NCT00726869
- Lead Sponsor
- Abbott
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 4 Elotuzumab (HuLuc63) 20.0 mg/kg Cohort 2 Elotuzumab (HuLuc63) 5.0 mg/kg Cohort 3 Elotuzumab (HuLuc63) 10.0 mg/kg Cohort 1 Elotuzumab (HuLuc63) 2.5 mg/kg
- Primary Outcome Measures
Name Time Method Identify the maximum tolerated dose of elotuzumab in combination with bortezomib (phase 1). 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). 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 Outcome Measures
Name Time Method Evaluate the efficacy of elotuzumab in combination with bortezomib (phase 1). Screening to the 30 day follow up visit. Objective response rate according to EBMT criteria, duration of response, time to progression, and progression-free survival
Evaluate the immunogenicity of elotuzumab in combination with bortezomib (phase 1 and 2). Screening to the 30 day follow up visit. Incidence of elotuzumab-specific antidrug antibodies
Evaluate the pharmacodynamics of elotuzumab in combination with bortezomib (phase 1 and 2). Screening to the 30 day follow up visit. Changes in pharmacodynamic endpoints as they relate to dose, response, and toxicity of elotuzumab in combination with bortezomib
Evaluate the pharmacokinetic parameters of elotuzumab in combination with bortezomib (phase 1 and 2) Screening to the 30 day follow up visit. Pharmacokinetic profile
Evaluate the safety of elotuzumab in combination with bortezomib (phase 1 and 2). Screening to the 30 day follow up visit. Frequency, severity, and relationship of adverse events and serious adverse events with the combination of elotuzumab and bortezomib
Trial Locations
- Locations (8)
Site Reference ID/Investigator# 63853
🇺🇸Los Angeles, California, United States
Site Reference ID/Investigator# 63850
🇺🇸Buffalo, New York, United States
Site Reference ID/Investigator# 63855
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 63854
🇺🇸Hackensack, New Jersey, United States
Site Reference ID/Investigator# 63852
🇺🇸Ann Arbor, Michigan, United States
Site Reference ID/Investigator# 63848
🇺🇸Seattle, Washington, United States
Site Reference ID/Investigator# 63847
🇺🇸Boston, Massachusetts, United States
Site Reference ID/Investigator# 63849
🇺🇸Columbus, Ohio, United States