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

Phase 1 Completed 6 enrolled Yale University Celgene Corporation · collab Kyowa Kirin, Inc. · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2009-04
Primary completion: 2011-05
Completion: 2011-05

Publications

Richter J, Neparidze N, Zhang L, Nair S, Monesmith T, Sundaram R, Miesowicz F, Dhodapkar KM, Dhodapkar MV. Clinical regressions and broad immune activation following combination therapy targeting human NKT cells in myeloma. Blood. 2013 Jan 17;121(3):423-30. doi: 10.1182/blood-2012-06-435503. Epub 2012 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenalidomide	Other / unclassified	10 mg	Oral
Subject	Lenalidomide	Other / unclassified	25 mg	Oral
Subject	Monocyte derived DCs loaded with KRN7000	Cell therapy	1e+07 cells	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications