MedTrace Logo

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.

NCT00726869 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-08-23

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Elotuzumab (HuLuc63)

Cohort 1 - 2.5 mg/kg elotuzumab IV with bortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8; Cohort 2 - 5.0 mg/kg elotuzumab IV with bortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8; Cohort 3 - 10.0 mg/kg elotuzumab IV withbortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8; and Cohort 4 - 20.0 mg/kg elotuzumab IV with bortezomib on Days 1 \& 11, with only Bortezomib IV on Days 4 \& 8.

Sponsors & Collaborators

Principal Investigators

  • Anil Singhal, PhD · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00726869 on ClinicalTrials.gov