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NCT01094548 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)

Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy · Source last updated 2016-02-22

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
From the first dose of study drug administration up to 42 days after the last dose of study drug administration or clinical data cut-off date (07 March 2012)

What was measured

TEAEs occurred between the first dose of study drug administration and up to 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. A Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 3 (NCI-CTCAE v3.0) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated. Injection site reactions, term used per NCI-CTCAE, were also presented.

Analysis population: Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.

Groups in this outcome

Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

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

Analysis denominator · Participants

GroupSource count
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide17
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide17

Reported measurements

TEAEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide17Not reportedNot reportedNot reportedNot reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide17Not reportedNot reportedNot reportedNot reported
Serious TEAEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide6Not reportedNot reportedNot reportedNot reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide5Not reportedNot reportedNot reportedNot reported
NCI-CTC Grade 3 and 4 TEAEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide5Not reportedNot reportedNot reportedNot reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide8Not reportedNot reportedNot reportedNot reported
TEAEs leading to discontinuation of treatment
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide1Not reportedNot reportedNot reportedNot reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide2Not reportedNot reportedNot reportedNot reported
ISRs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide8Not reportedNot reportedNot reportedNot reported
Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        17
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
    title
    Serious TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        8
    title
    NCI-CTC Grade 3 and 4 TEAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    TEAEs leading to discontinuation of treatment
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        11
    title
    ISRs
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      17
    units
    Participants
description
TEAEs occurred between the first dose of study drug administration and up to 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. A Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 3 (NCI-CTCAE v3.0) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated. Injection site reactions, term used per NCI-CTCAE, were also presented.
groups
  1. description
    Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide \[L-BLP25\]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.
    id
    OG000
    title
    Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide
  2. description
    Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented. Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.
    id
    OG001
    title
    Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
param Type
NUMBER
population Description
Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.
reporting Status
POSTED
time Frame
From the first dose of study drug administration up to 42 days after the last dose of study drug administration or clinical data cut-off date (07 March 2012)
title
Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice