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NCT00985959 · OUTCOME

Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II

A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT) · Source last updated 2013-12-02

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
54 weeks

What was measured

Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions

Analysis population: Full analysis set: All participants who received at least one dose of the study medication.

Groups in this outcome

Phase I - JNJ-26866138 0.7 mg/m2 Group

JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

Phase I - JNJ-26866138 1.0 mg/m2 Group

JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

Phase I - JNJ-26866138 1.3 mg/m2 Group

JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

Phase II - JNJ-26866138 1.3 mg/m2 Group

JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles

Total

Participants from both Phase I and Phase II

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

Analysis denominator · Participants

GroupSource count
Phase I - JNJ-26866138 0.7 mg/m2 Group6
Phase I - JNJ-26866138 1.0 mg/m2 Group6
Phase I - JNJ-26866138 1.3 mg/m2 Group5
Phase II - JNJ-26866138 1.3 mg/m2 Group86
Total98

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - JNJ-26866138 0.7 mg/m2 Group6Not reported54.1100.0Not reported
Phase I - JNJ-26866138 1.0 mg/m2 Group5Not reported35.999.6Not reported
Phase I - JNJ-26866138 1.3 mg/m2 Group4Not reported28.499.5Not reported
Phase II - JNJ-26866138 1.3 mg/m2 Group60Not reported58.979.2Not reported
Total71Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    58.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    79.2
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    4.9
    group Ids
    1. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    Significance level 5% one-tailed. Threshold response rate 35%
    param Type
    Overall response rate (%)
    param Value
    69.8
    statistical Method
    Binominal test
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    58.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    79.2
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    4.9
    group Ids
    1. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    Significance level 5% one-tailed. Threshold response rate 35%
    param Type
    Overall response rate (%)
    param Value
    69.8
    statistical Method
    Binominal test
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.1
        upper Limit
        100.0
        value
        6
      2. group Id
        OG001
        lower Limit
        35.9
        upper Limit
        99.6
        value
        5
      3. group Id
        OG002
        lower Limit
        28.4
        upper Limit
        99.5
        value
        4
      4. group Id
        OG003
        lower Limit
        58.9
        upper Limit
        79.2
        value
        60
      5. group Id
        OG004
        value
        71
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      86
    5. group Id
      OG004
      value
      98
    units
    Participants
description
Response is evaluated as per the criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation (Blade et al. 1998). CR: disappearance of the original monoclonal protein from the blood and urine and \<5% plasma cells in the bone marrow on at least 2 determinations for a minimum of 6 weeks; no increase in the size or number of lytic bone lesions; disappearance of soft tissue plasmacytomas for at least 6 weeks. PR: ≥50% reduction in the level of serum monoclonal protein for at least 2 determinations 6 weeks apart; If present, reduction in 24-hour urinary light chain excretion by either ≥90% or to \<200 mg for at least 2 determinations 6 weeks apart; ≥50% reduction in the size of soft tissue plasmacytomas for at least 6 weeks; no increase in size or number of lytic bone lesions
groups
  1. description
    JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    OG000
    title
    Phase I - JNJ-26866138 0.7 mg/m2 Group
  2. description
    JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    OG001
    title
    Phase I - JNJ-26866138 1.0 mg/m2 Group
  3. description
    JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    OG002
    title
    Phase I - JNJ-26866138 1.3 mg/m2 Group
  4. description
    JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
    id
    OG003
    title
    Phase II - JNJ-26866138 1.3 mg/m2 Group
  5. description
    Participants from both Phase I and Phase II
    id
    OG004
    title
    Total
param Type
NUMBER
population Description
Full analysis set: All participants who received at least one dose of the study medication.
reporting Status
POSTED
time Frame
54 weeks
title
Number of Participants With Overall Response (Complete Response [CR] + Partial Response [PR]) - Phase I and II
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice