UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma (NK2010-35)
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|ClinicalTrials.gov Identifier: NCT01313897|
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : April 13, 2017
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bortezomib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||UARK 2010-35, A Phase II Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma|
|Study Start Date :||January 2011|
|Primary Completion Date :||October 2016|
|Study Completion Date :||October 2016|
Experimental: Velcade for Anti-MM therapy
Day(s) -9,-6,-2 3 doses of Bortezomib at 1.0 mg/m2, i.v.
bortezomib to be given days -9, -6, and -2 at 1.0mg/m2, i.v.
Other Name: Velcade
- Therapeutic Efficacy [ Time Frame: 180 days ]Number of participants with an objective response of Partial Response (PR) or better according to European Society for Blood and Marrow Transplantation (EBMT) criteria within 180 days post Expanded Natural Killer Cell Infusion. The minimum criteria to meet the EBMT definition of PR or better included: >= 50% reduction in size of soft tissue plasmacytomas (if assessed); AND >= 50% reduction in plasma cells in bone marrow biopsy (if biopsy was performed and if >= 30% plasma cells at baseline); AND >=50% reduction in serum M protein and reduction in urine M protein >= 90% or to 200 mg/24hr OR >= 50% decrease in the difference between involved and uninvolved serum free light chain levels (if serum M protein < 1 g/dL, urine < 200 mg/24 hrs, and an involved serum free light chain level >= 10 mg/dL at baseline).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313897
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Frits van Rhee, M.D., PHD.||University of Arkansas|