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NCT00918333 · OUTCOME

Overall Survival Time (Phase II)

Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma · Source last updated 2020-03-10

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Time from registration to death due to any cause, assessed up to 2 years post-treatment

What was measured

Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.

Analysis population: Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.

Groups in this outcome

Phase II (Lymphoma Patients Receiving 20 mg LBL589)

Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II (Myeloma Patients Receiving 20 mg LBH589)

Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)

Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Phase II (Myeloma Patients Receiving 30/40 mg LBH589)

Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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 II (Lymphoma Patients Receiving 20 mg LBL589)41
Phase II (Myeloma Patients Receiving 20 mg LBH589)14
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)20
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)18

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II (Lymphoma Patients Receiving 20 mg LBL589)17.1Not reported7.0NAThe upper bound of the 95% confidence interval has not yet been reached.
Phase II (Myeloma Patients Receiving 20 mg LBH589)16.6Not reported9.7NAThe upper bound of the 95% confidence interval has not yet been reached.
Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)35.4Not reported11.5NAThe upper bound of the 95% confidence interval has not yet been reached.
Phase II (Myeloma Patients Receiving 30/40 mg LBH589)21.7Not reported12.147.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper bound of the 95% confidence interval has not yet been reached.
        group Id
        OG000
        lower Limit
        7.0
        upper Limit
        NA
        value
        17.1
      2. comment
        The upper bound of the 95% confidence interval has not yet been reached.
        group Id
        OG001
        lower Limit
        9.7
        upper Limit
        NA
        value
        16.6
      3. comment
        The upper bound of the 95% confidence interval has not yet been reached.
        group Id
        OG002
        lower Limit
        11.5
        upper Limit
        NA
        value
        35.4
      4. group Id
        OG003
        lower Limit
        12.1
        upper Limit
        47.6
        value
        21.7
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      20
    4. group Id
      OG003
      value
      18
    units
    Participants
description
Overall survival time is defined as the time from registration to death due to any cause. The median and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Lymphoma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Phase II (Lymphoma Patients Receiving 20 mg LBL589)
  2. description
    Myeloma patients receive 20 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Phase II (Myeloma Patients Receiving 20 mg LBH589)
  3. description
    Lymphoma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG002
    title
    Phase II (Lymphoma Patients Receiving 30/40 mg LBH589)
  4. description
    Myeloma patients receive 30 or 40 mg/day panobinostat (LBH589) PO on days 1, 3, 5, 15, 17, and 19 and 5 mg/day everolimus PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG003
    title
    Phase II (Myeloma Patients Receiving 30/40 mg LBH589)
param Type
MEDIAN
population Description
Patients who were enrolled in and completed Phase II and treated at a starting dose of 20 mg or 30/40 mg LBH589 were evaluated in this analysis.
reporting Status
POSTED
time Frame
Time from registration to death due to any cause, assessed up to 2 years post-treatment
title
Overall Survival Time (Phase II)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice