NCT01313897

UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma

UARK 2010-35, A Phase II Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the therapeutic efficacy of the exp-NK cell therapy in research participants with relapsed high risk MM \[defined as gene expression profile (GEP) 70 gene score ≥0.66 and/or metaphase chromosomal abnormalities and/or high LDH ≥ 360U/L\] by establishing the (near) complete response rate. Response rate will be compared to case matched historical controls (patients who relapsed on Total Therapy 2 or 3 with high-risk MM defined as above). Disease-free survival and overall survival will be captured but are not primary or secondary endpoints.

Detailed description

The use of auto-exp-NK cells in this protocol makes therapy available to all refractory high risk MM patients, 2/3 of whom would otherwise not have a suitable haploidentical donor. We have shown that NK cells can be expanded both from newly diagnosed high risk MM patients and from refractory, previously heavily treated patients, the very individuals in need of novel therapies such as exp-NK cell infusions. Furthermore, we observed that exp-NK cells have the ability to kill auto-MM cells in vitro compared to no killing with resting auto-NK cells. This may be due to the elevated activation state of exp-NK cells, which allows them to overcome otherwise dominant inhibitory signaling. The incorporation of the proteasome inhibitor bortezomib, which down regulates the principal NK cell inhibitory ligands on MM cells should further increase the efficacy of auto-exp-NK cells. Because there is no risk for GvHD, CD3+ T cell depletion will not be necessary for auto-exp-NK cell products.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib	bortezomib to be given days -9, -6, and -2 at 1.0mg/m2, i.v.

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2011-03-14
• Last updated: 2017-05-19
• Results posted: 2017-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study