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NCT01858558 · OUTCOME

Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product

Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma · Source last updated 2020-06-29

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
120 days

What was measured

Feasibility is defined as the ability to harvest, expand, and infuse the MILs product within 120 days. After treating 60 patients with MILs, we will declare MILs not feasible if we can only harvest, expand, and deliver MILs to 40 or fewer patients.

Analysis population: 71 patients were evaluable in the feasibility set: 70 randomized to the aMILs Arm, plus one patient who was not randomized due to harvest failure.

Groups in this outcome

aMIL Arm

Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.

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

Analysis denominator · Participants

GroupSource count
aMIL Arm71

Reported measurements

Total number who received aMILS
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
aMIL Arm71Not reportedNot reportedNot reportedNot reported
Feasible
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
aMIL Arm46Not reportedNot reportedNot reportedNot reported
Reason not feasible- failed harvest
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
aMIL Arm1Not reportedNot reportedNot reportedNot reported
Reason not feasible- disease progression
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
aMIL Arm4Not reportedNot reportedNot reportedNot reported
Reason not feasible- death
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
aMIL Arm1Not reportedNot reportedNot reportedNot reported
Reason not feasible- lost to follow-up
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
aMIL Arm1Not reportedNot reportedNot reportedNot reported
Reason not feasible- failed expansion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
aMIL Arm2Not reportedNot reportedNot reportedNot reported
Reason not feasible- cell product contamination
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
aMIL Arm2Not reportedNot reportedNot reportedNot reported
Reason not feasible- greater than 120 days
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
aMIL Arm14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        71
    title
    Total number who received aMILS
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        46
    title
    Feasible
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Reason not feasible- failed harvest
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Reason not feasible- disease progression
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Reason not feasible- death
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Reason not feasible- lost to follow-up
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Reason not feasible- failed expansion
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Reason not feasible- cell product contamination
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Reason not feasible- greater than 120 days
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
Feasibility is defined as the ability to harvest, expand, and infuse the MILs product within 120 days. After treating 60 patients with MILs, we will declare MILs not feasible if we can only harvest, expand, and deliver MILs to 40 or fewer patients.
groups
  1. description
    Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
    id
    OG000
    title
    aMIL Arm
param Type
COUNT_OF_PARTICIPANTS
population Description
71 patients were evaluable in the feasibility set: 70 randomized to the aMILs Arm, plus one patient who was not randomized due to harvest failure.
reporting Status
POSTED
time Frame
120 days
title
Feasibility of MILs as Assessed by the Ability to Harvest, Expand, and Infuse the MILs Product
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice