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NCT02481934 · REGISTRY CONDITION SEARCH

Clinical Trial of Expanded and Activated Autologous NK Cells to Treat Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2021-08-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Adverse Events During NKAE Treatment

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outcome · POSTED

Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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.
healthy Volunteers
false
maximum Age
80 Years
minimum Age
20 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).
    intervention Names
    1. Procedure: NKAE cells infusion
    2. Drug: Lenalidomide
    3. Drug: Bortezomib
    label
    NKAE cells infusion + chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. NKAE cells infusion + chemotherapy
    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.
    name
    NKAE cells infusion
    other Names
    1. NKAE infusion
    2. Activated and expanded autologous NK cells infusion
    type
    PROCEDURE
  2. arm Group Labels
    1. NKAE cells infusion + chemotherapy
    description
    Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.
    name
    Lenalidomide
    other Names
    1. Revlimid
    type
    DRUG
  3. arm Group Labels
    1. NKAE cells infusion + chemotherapy
    description
    Bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.
    name
    Bortezomib
    other Names
    1. Velcade
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Toxicity will be assessed by adverse events count during NKAE treatment monitoring peripheral blood absolute neutrophil count (cells/μl). Toxicity will be evaluated monthly during NKAE treatment (4 months). During follow-up, it will be assessed monthly the first 6 months. After that, quarterly until one year of follow-up, based on Common Toxicity Criteria for Adverse Events of the National Cancer Institute (CTCAE) to v.4.03.
    measure
    Number of Participants With Adverse Events During NKAE Treatment
    time Frame
    16 months
secondary Outcomes
  1. description
    Efficacy will be assessed monthly during NKAE treatment (4 months) by peripheral blood monoclonal protein monitoring. During follow-up, efficacy will be evaluated monthly the first 6 months. After that, quarterly until one year of follow-up.
    measure
    Number of Participants With Peripheral Blood Monoclonal Protein Reduction or Stabilization
    time Frame
    16 months
Full study description
brief 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.
detailed Description
It is expected to enroll 10 to 15 patients within 18 months. Patients have to achieve stable disease after induction therapy. Peripheral blood from patients will be collected every cycle (n=4) to produce NKAEs under Good Manufacturing Practice (GMP) conditions peripheral blood mononuclear cell (PBMCs) will be co-cultured with a genetically modified cell line (K562-mb15-41BBL) and 100 IU/ml interleukin-2. Treatment consists of 4 cycles of anti-myeloma consolidation treatment with two infusions of NKAEs every day 1 and 8 of each cycle. Usually, chosen treatment regime will be bortezomib (Velcade) or lenalidomide (Revlimid). These treatments are used to be combined with corticosteroid medications which needs to be suspended before NKAEs infusions. A washout period of 2 weeks is required. NKAEs dose of cells will be constant, 7.5x106/kg. There will be an interim analysis intra-cohort one week after the first batch of two infusions. If at the analysis no grade IV adverse effect is observed we will proceed to the second cycle and the inclusion of other patients.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      requested nct id
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      primary nct id
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      source kind
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      payload sha256
      69e7567fc5ab5ef5c7ec05d4eb6872ac3c7a53b666b28ea6efb39c0f2911718f
      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-26d84d07d3b77a3537b2
      link basis
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      nct id
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      occurrences
      1. context exact
        NCT02481934
        end
        11
        exact text
        NCT02481934
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/44/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      dc462ca8a6dd9523c24066e6cb530346237e26c1bb2edad75ea364114978521c

    Preserved source evidence · Not medical advice