UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and in vivo persistence and expansion of autologous and expansion of autologous, ex vivo expanded-natural killer(ENK) cells.

Detailed Description
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To determine whether significant in vivo expansion of auto-ENK cells occurs, defined as a > 4 fold increase in absolute cluster of differentiation 3(CD3)-cluster of differentiation 56 (CD56+) NK cell count/blood 7 days after infusion over the pre-study baseline level and the safety of the ENK cell therapy in research participants with high-risk asymptomatic multiple myeloma (AMM) defined as gene expression profile (GEP) 70 gene score>-0.26.

Official Title
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A Phase II Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma

Conditions
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Asymptomatic Multiple Myeloma

Intervention / Treatment
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* Drug: ENK Cell Infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study population will be participants with AMM being seen at Myeloma Institute for Research and Therapy (MIRT), and under continuing followup with standard clinical care testing . Participants must have a diagnosis of AMM as defined in Staging Criteria (Section 3.0) and GEP-70 score >-0.26. Participant (male or female) from any race or ethnicity must be at least 18 years of age and not older than 75 years of age at the time of registration. Participants must have a performance status of 0 - 2 by Zubrod criteria Participants must have signed an Institutional Review Board (IRB)-approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization form. Must be fit to undergo leukapheresis for ENK cell generation as determined by PI. Must be a suitable candidate for insertion of apheresis catheter. Participants with unusual anatomy or vascular anomalies preventing insertion of apheresis catheter will not qualify. Patients must have previous test results indicating adequate pulmonary function studies (PFT) > 50% of predicted on mechanical aspects (FEV1, forced vital capacity(FVC), etc) and diffusion capacity (DLCO) > 50% of predicted. Exclusion Criteria: Participants must not have received prior treatment for their disease. Prior use of bisphosphonates is permitted. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 2 years. May not have history of poorly-controlled hypertension, diabetes mellitus, or any other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or could be considered to be an exclusion criterion deemed by the PI. Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within 10 to 14 days of enrollment. Women/men of reproductive potential may not participate unless they have either agreed to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg,calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) OR begin TWO reliable methods of birth control: 1 highly effective method and 1 additional effective method AT THE SAME TIME, at least 28 days before starting study treatment through 30 days after the last dose of study treatment. Serologic evaluation will be used to assess exposure to syphilis, West Nile Virus, Chagas, cytomegalovirus (CMV), Immunoglobulin G (IgG), hepatitis B, and C, HIV I and II, and human t cell lymphoma virus (HTLV) I/II. Participants may not be hepatitis B or C (+) unless positive due to previous vaccination or positive but has received therapy and is negative for hepatitis B or C by rapid test polymerase chain reaction (RT-PCR). An HIV-I/II(+) and HTLV-1/II (+) participant will be rejected on medical grounds. Participants serologically positive for syphilis, West Nile Virus, Chagas, CMV, are only excluded if they are being treated for active infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENK Cell Infusion<br>Expanded Natural Killer Cell Infusion | Drug: ENK Cell Infusion<br>* Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU<br>* Other names: Auto-ENK Cell Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment | Number of participants with at least 4 fold increase in absolute CD3-CD56+ NK cell count/uL blood 7 days after infusion over the pre-study baseline level | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asymptomatic Multiple Myeloma, Auto-ENK Cell Therapy, Natural Killer Cells