NCT00698776

Combination of Lenalidomide and Autologous Mature Dendritic Cells Pulsed With KRN7000 in Myeloma

Phase I/II Trial of Combination of Lenalidomide (Revlimid, LEN) and Autologous Mature Dendritic Cells Pulsed With α-galactosyl Ceramide (α-GalCer; KRN7000) in Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm open label trial to test the tolerability of the combination of monocyte derived DCs loaded with KRN7000 (DC-KRN7000) and Lenalidomide (LEN) in patients with asymptomatic myeloma. Phase I component of the study will evaluate the optimal dose of LEN, with particular emphasis on safety. After an interim analysis of these data, a single dose level will be chosen for phase II component in additional patients.

Conditions

• Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide	10 mg/day in cohort 1, and 25 mg/day in cohort 2. LEN is administered orally in standard 21 day cycles starting one week before each DC injection and ending 14 days after each DC injection. All patients will receive a total of three cycles of LEN.
BIOLOGICAL	Monocyte derived DCs loaded with KRN7000	10 million DCs injected intravenously

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2008-06-17
• Last updated: 2016-06-21

Locations

1 site across 1 country: United States