UARK 2013-05 A Study of Autologous Expanded Natural Killer Cell Therapy for Asymptomatic Multiple Myeloma
Condition: Asymptomatic Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma
Intervention: ENK Cell Infusion
Intervention description: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asymptomatic Multiple Myeloma; Auto-ENK Cell Therapy; Natural Killer Cells

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.
    

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.