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NCT01109004 · OUTCOME

Percentage of Participants With Progression-free Survival (PFS)

Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702) · Source last updated 2021-12-09

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
38 months post-randomization

What was measured

Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.

Groups in this outcome

Tandem Auto Transplant

Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

RVD Consolidation

Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

Lenalidomide Maintenance

Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.

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

Analysis denominator · Participants

GroupSource count
Tandem Auto Transplant247
RVD Consolidation254
Lenalidomide Maintenance257

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tandem Auto Transplant58.5Not reported51.764.6Not reported
RVD Consolidation57.8Not reported51.463.7Not reported
Lenalidomide Maintenance53.9Not reported47.460.0Not reported

Source statistical analyses

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

  1. group Description
    The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.87
    p Value Comment
    The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.
    statistical Comment
    The log rank test was stratified on risk status (high risk vs. standard risk)
    statistical Method
    Log Rank
  2. group Description
    The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.37
    p Value Comment
    The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.
    statistical Comment
    The log rank test was stratified on risk status (high risk vs. standard risk)
    statistical Method
    Log Rank
  3. group Description
    The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.27
    p Value Comment
    The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.
    statistical Comment
    The log rank test was stratified on risk status (high risk vs. standard risk)
    statistical Method
    Log Rank
Complete source fields
analyses
  1. group Description
    The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and RVD consolidation therapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.87
    p Value Comment
    The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.
    statistical Comment
    The log rank test was stratified on risk status (high risk vs. standard risk)
    statistical Method
    Log Rank
  2. group Description
    The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving Tandem auto transplant and Lenalidomide maintenance therapy.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.37
    p Value Comment
    The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.
    statistical Comment
    The log rank test was stratified on risk status (high risk vs. standard risk)
    statistical Method
    Log Rank
  3. group Description
    The null hypothesis is that the percentages of participants with PFS at 38 months post-randomization are equal for those receiving RVD consolidation and Lenalidomide maintenance therapy.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.27
    p Value Comment
    The primary analysis involved pairwise comparisons of PFS between the three treatment arms. To control the familywise type I error rate at 0.05, two-sided testing was performed at a Bonferroni-adjusted significance level of 0.0167 = 0.05 / 3.
    statistical Comment
    The log rank test was stratified on risk status (high risk vs. standard risk)
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        51.7
        upper Limit
        64.6
        value
        58.5
      2. group Id
        OG001
        lower Limit
        51.4
        upper Limit
        63.7
        value
        57.8
      3. group Id
        OG002
        lower Limit
        47.4
        upper Limit
        60.0
        value
        53.9
denoms
  1. counts
    1. group Id
      OG000
      value
      247
    2. group Id
      OG001
      value
      254
    3. group Id
      OG002
      value
      257
    units
    Participants
description
Progression-free survival is defined as survival without disease progression or initiation of non-protocol anti-myeloma therapy. To account for loss to follow-up of a few participants, the Kaplan-Meier estimator was used to estimate progression-free survival at 38 months post-randomization.
dispersion Type
95% Confidence Interval
groups
  1. description
    Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
    id
    OG000
    title
    Tandem Auto Transplant
  2. description
    Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance lenalidomide, bortezomib and dexamethasone: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
    id
    OG001
    title
    RVD Consolidation
  3. description
    Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m\^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
    id
    OG002
    title
    Lenalidomide Maintenance
param Type
NUMBER
reporting Status
POSTED
time Frame
38 months post-randomization
title
Percentage of Participants With Progression-free Survival (PFS)
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice