Clinical Trial of Expanded and Activated Autologous NK Cells to Treat Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: NKAE cells infusion; Lenalidomide; Bortezomib
Intervention description: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.; Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.; Bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.
Intervention MeSH terms: Lenalidomide; Bortezomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Recurrent multiple myeloma; NK cells; cell therapy; NKAE; Relapsed multiple myeloma

Summary:

      The purpose of this study is to determine wether activated and expanded autologous Natural
      Killer cells (NKAEs) are effective in the treatment of patients with multiple myeloma on
      second or later relapse. NKAEs are used in combination with anti-myeloma drugs such as
      lenalidomide or bortezomib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 20 and 80 years old

          -  With multiple myeloma in 2nd or later relapse or showing resistance after 2 treatment
             lines

          -  Eastern Cooperative Oncology Group (ECOG) ≤ 2

          -  Life expectancy greater than six months

          -  Creatinine clearance rate more than 30 ml / min

          -  Subjects who have received at least 4 cycles of rescue treatment under the procedures
             of the 12 de Octubre Hospital (rescue treatment will vary depending on previous
             anti-myeloma treatment). After treatment, patients must have shown chemosensitivity
             and disease stabilization.

          -  Will be included subjects with partial response or stable disease (for at least 2
             cycles) after 75% of planned rescue treatment or patients at subclinical progression
             (defined as an increase of monoclonal component ≥ 25%) at any time of rescue
             treatment. Subjects have to show tolerance to rescue treatment, without G3/4 adverse
             effects, if G1/2 adverse effects exist they must be analyzed immediately before
             starting reinfusion program.

          -  Subjects have to agree to participate in the trial and they have to sign informed
             consent.

        Exclusion Criteria:

          -  Subjects with clinical progression or complete response will not be included.

          -  Any of the following abnormal laboratory results:

        Absolute Neutrophil Count < 1000/ µL Platelets Count < 50000/ µL in those patients with
        bone marrow infiltration lower than 50% Measured creatinine clearance <30 ml/min Hemoglobin
        level ≤ 8 g/dL Peripheral neuropathy ≥ Grade 2

          -  Subjects have received allogeneic stem cell transplant.

          -  Subjects with heart disease which compromises patient's life or protocol
             accomplishment.

          -  Subjects with past clinical history of malignant disease within 3 years (exceptions
             are squamous or basal cell carcinoma).

          -  Subjects receiving another investigational drug or having received investigational
             drug within 30 days before screening.

          -  Subjects who require chronic steroid or immunosuppressive treatment.

          -  Any condition, including abnormally laboratory results, that might compromise the
             patient´s life if he participate in this study.

          -  Any concurrent medical condition, abnormally laboratory results or any psychological
             disorder that prevent the patient to sign the informed consent.

          -  Pregnant or fertile women.

          -  Patients known to be seropositive for human immunodeficiency virus (VIH) or having
             active hepatitis A, B or C.