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NCT01313897 · OUTCOME

Therapeutic Efficacy

UARK 2010-35, A Study of Expanded Natural Killer Cell Therapy for Multiple Myeloma · Source last updated 2017-05-19

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
180 days

What was measured

Number of participants with an objective response of Partial Response (PR) or better according to European Society for Blood and Marrow Transplantation (EBMT) criteria within 180 days post Expanded Natural Killer Cell Infusion. The minimum criteria to meet the EBMT definition of PR or better included: \>= 50% reduction in size of soft tissue plasmacytomas (if assessed); AND \>= 50% reduction in plasma cells in bone marrow biopsy (if biopsy was performed and if \>= 30% plasma cells at baseline); AND \>=50% reduction in serum M protein and reduction in urine M protein \>= 90% or to 200 mg/24hr OR \>= 50% decrease in the difference between involved and uninvolved serum free light chain levels (if serum M protein \< 1 g/dL, urine \< 200 mg/24 hrs, and an involved serum free light chain level \>= 10 mg/dL at baseline).

Groups in this outcome

Velcade for Anti-MM Therapy

Day(s) -9,-6,-2 3 doses of Bortezomib at 1.0 mg/m2, i.v. Bortezomib: bortezomib given days -9, -6, and -2 at 1.0mg/m2, i.v.

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

Analysis denominator · Participants

GroupSource count
Velcade for Anti-MM Therapy8

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Velcade for Anti-MM Therapy1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Number of participants with an objective response of Partial Response (PR) or better according to European Society for Blood and Marrow Transplantation (EBMT) criteria within 180 days post Expanded Natural Killer Cell Infusion. The minimum criteria to meet the EBMT definition of PR or better included: \>= 50% reduction in size of soft tissue plasmacytomas (if assessed); AND \>= 50% reduction in plasma cells in bone marrow biopsy (if biopsy was performed and if \>= 30% plasma cells at baseline); AND \>=50% reduction in serum M protein and reduction in urine M protein \>= 90% or to 200 mg/24hr OR \>= 50% decrease in the difference between involved and uninvolved serum free light chain levels (if serum M protein \< 1 g/dL, urine \< 200 mg/24 hrs, and an involved serum free light chain level \>= 10 mg/dL at baseline).
groups
  1. description
    Day(s) -9,-6,-2 3 doses of Bortezomib at 1.0 mg/m2, i.v. Bortezomib: bortezomib given days -9, -6, and -2 at 1.0mg/m2, i.v.
    id
    OG000
    title
    Velcade for Anti-MM Therapy
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
180 days
title
Therapeutic Efficacy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice