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NCT02322320 · OUTCOME

Percentage of Participants With Secondary Primary Malignancies (SPM)

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). SPM is defined as development of any second malignancy, excluding non-melanoma skin cancers. To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of SPM during the 5 year post-randomization follow-up period. The development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms.

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 Transplant10.8Not reported7.215.1Not reported
RVD Consolidation7.9Not reported4.911.6Not reported
Lenalidomide Maintenance7.2Not reported4.310.8Not 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 SPM 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
    0.43
    p Value Comment
    The analysis involved pairwise comparisons of SPM 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
    Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Gray's test
  2. group Description
    The null hypothesis is that the percentages of participants with SPM 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
    0.70
    p Value Comment
    The analysis involved pairwise comparisons of SPM 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
    Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Gray's test
  3. group Description
    The null hypothesis is that the percentages of participants with SPM 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
    0.70
    p Value Comment
    The analysis involved pairwise comparisons of SPM 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
    Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Gray's test
Complete source fields
analyses
  1. group Description
    The null hypothesis is that the percentages of participants with SPM 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
    0.43
    p Value Comment
    The analysis involved pairwise comparisons of SPM 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
    Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Gray's test
  2. group Description
    The null hypothesis is that the percentages of participants with SPM 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
    0.70
    p Value Comment
    The analysis involved pairwise comparisons of SPM 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
    Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Gray's test
  3. group Description
    The null hypothesis is that the percentages of participants with SPM 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
    0.70
    p Value Comment
    The analysis involved pairwise comparisons of SPM 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
    Gray's test was stratified on risk status at BMT CTN 0702 enrollment (high risk vs. standard risk)
    statistical Method
    Gray's test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.2
        upper Limit
        15.1
        value
        10.8
      2. group Id
        OG001
        lower Limit
        4.9
        upper Limit
        11.6
        value
        7.9
      3. group Id
        OG002
        lower Limit
        4.3
        upper Limit
        10.8
        value
        7.2
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). SPM is defined as development of any second malignancy, excluding non-melanoma skin cancers. To account for loss to follow-up, the Aalen-Johansen estimator was used to estimate the cumulative incidence of SPM during the 5 year post-randomization follow-up period. The development of any SPMs excludes non-melanoma skin cancers. Death without SPMs will be considered a competing risk for this event. The cumulative incidence of SPMs will be compared between treatment arms.
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 Secondary Primary Malignancies (SPM)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice