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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01884688
Recruitment Status : Completed
First Posted : June 24, 2013
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asymptomatic Multiple Myeloma Drug: ENK Cell Infusion Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
Study Start Date : April 2013
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: ENK Cell Infusion
Expanded Natural Killer Cell Infusion
Drug: ENK Cell Infusion
Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
Other Name: Auto-ENK Cell Therapy

Primary Outcome Measures :
  1. Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment [ Time Frame: 7 days ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01884688

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United States, Arkansas
University of Arkansas for Medical Science
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Millennium Pharmaceuticals, Inc.
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Principal Investigator: Frits Van Rhee, M.D., Phd University of Arkansas
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Responsible Party: University of Arkansas Identifier: NCT01884688    
Other Study ID Numbers: 138826
First Posted: June 24, 2013    Key Record Dates
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017
Keywords provided by University of Arkansas:
Asymptomatic Multiple Myeloma
Auto-ENK Cell Therapy
Natural Killer Cells
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Precancerous Conditions