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NCT02481934 · OUTCOME

Number of Participants With Adverse Events During NKAE Treatment

Clinical Trial of Expanded and Activated Autologous NK Cells to Treat Multiple Myeloma · Source last updated 2021-08-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
16 months

What was measured

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.

Analysis population: Analysis per protocol

Groups in this outcome

NKAE Cells Infusion + Chemotherapy

Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib). NKAE cells infusion: 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: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles. Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
NKAE Cells Infusion + Chemotherapy5

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NKAE Cells Infusion + Chemotherapy2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
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.
groups
  1. description
    Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib). NKAE cells infusion: 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: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles. Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.
    id
    OG000
    title
    NKAE Cells Infusion + Chemotherapy
param Type
NUMBER
population Description
Analysis per protocol
reporting Status
POSTED
time Frame
16 months
title
Number of Participants With Adverse Events During NKAE Treatment
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice