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NCT02322320 · OUTCOME

Percentage of Participants With Overall Survival (OS)

Continued, Long-Term Follow-Up and Lenalidomide Maintenance Therapy for Patients on BMT CTN 0702 Protocol (BMT CTN 07LT) · Source last updated 2020-05-11

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
5 years post-randomization in BMT CTN 0702

What was measured

This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Overall survival is defined as survival of death from any cause. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate overall survival during the 5 year post-randomization follow-up period.

Analysis population: All 754 randomized BMT CTN 0702 participants are included in this analysis

Groups in this outcome

Tandem Auto Transplant

Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.

RVD Consolidation

Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.

Lenalidomide Maintenance

Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.

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 Transplant74.7Not reported69.180.0Not reported
RVD Consolidation75.4Not reported70.080.6Not reported
Lenalidomide Maintenance76.4Not reported71.081.5Not 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 OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.57
    p Value Comment
    The analysis involved pairwise comparisons of OS 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 at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Log Rank
  2. group Description
    The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.38
    p Value Comment
    The analysis involved pairwise comparisons of OS 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 at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Log Rank
  3. group Description
    The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.77
    p Value Comment
    The analysis involved pairwise comparisons of OS 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 at BMT CTN 0702 enrollment (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 OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and RVD consolidation therapy.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.57
    p Value Comment
    The analysis involved pairwise comparisons of OS 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 at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Log Rank
  2. group Description
    The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to Tandem auto transplant and Lenalidomide maintenance therapy.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.38
    p Value Comment
    The analysis involved pairwise comparisons of OS 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 at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Log Rank
  3. group Description
    The null hypothesis is that the percentages of participants with OS at 5 years post-randomization in BMT CTN 0702 are equal for those assigned to RVD consolidation and Lenalidomide maintenance therapy.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.77
    p Value Comment
    The analysis involved pairwise comparisons of OS 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 at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.1
        upper Limit
        80.0
        value
        74.7
      2. group Id
        OG001
        lower Limit
        70.0
        upper Limit
        80.6
        value
        75.4
      3. group Id
        OG002
        lower Limit
        71.0
        upper Limit
        81.5
        value
        76.4
denoms
  1. counts
    1. group Id
      OG000
      value
      247
    2. group Id
      OG001
      value
      254
    3. group Id
      OG002
      value
      257
    units
    Participants
description
This analysis includes all randomized subjects from the BMT CTN 0702 protocol classified according to their randomized treatment assignment (intention-to-treat). Overall survival is defined as survival of death from any cause. To account for loss to follow-up, the Kaplan-Meier estimator was used to estimate overall survival during the 5 year post-randomization follow-up period.
dispersion Type
95% Confidence Interval
groups
  1. description
    Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
    id
    OG000
    title
    Tandem Auto Transplant
  2. description
    Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
    id
    OG001
    title
    RVD Consolidation
  3. description
    Initial autologous transplant followed by lenalidomide maintenance Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
    id
    OG002
    title
    Lenalidomide Maintenance
param Type
NUMBER
population Description
All 754 randomized BMT CTN 0702 participants are included in this analysis
reporting Status
POSTED
time Frame
5 years post-randomization in BMT CTN 0702
title
Percentage of Participants With Overall Survival (OS)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice