UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
Primary Purpose
Asymptomatic Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ENK Cell Infusion
Sponsored by
About this trial
This is an interventional prevention trial for Asymptomatic Multiple Myeloma focused on measuring Asymptomatic Multiple Myeloma, Auto-ENK Cell Therapy, Natural Killer Cells
Eligibility Criteria
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.
Sites / Locations
- University of Arkansas for Medical Science
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ENK Cell Infusion
Arm Description
Expanded Natural Killer Cell Infusion
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01884688
First Posted
June 10, 2013
Last Updated
March 3, 2017
Sponsor
University of Arkansas
Collaborators
Millennium Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01884688
Brief Title
UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
Official Title
A Phase II Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Millennium Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic Multiple Myeloma
Keywords
Asymptomatic Multiple Myeloma, Auto-ENK Cell Therapy, Natural Killer Cells
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ENK Cell Infusion
Arm Type
Experimental
Arm Description
Expanded Natural Killer Cell Infusion
Intervention Type
Drug
Intervention Name(s)
ENK Cell Infusion
Other Intervention Name(s)
Auto-ENK Cell Therapy
Intervention Description
Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
Primary Outcome Measure Information:
Title
Increase in ENK (Expanded Natural Killer Cells) Cells 7 Days After Treatment
Description
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
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frits Van Rhee, M.D., Phd
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Science
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
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