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NCT01109004 · OUTCOME

Number of Participants With Treatment Response

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
1 and 2 years post-randomization

What was measured

The number of participants with very good partial response (VGPR) or better \[complete response (CR), near CR (nCR), and stringent CR (sCR)\] according to the International Uniform Response Criteria will be calculated. The "Worse than VGPR" group includes PR, stable disease, and progressive disease. sCR requires, in addition to CR: Normal free light chain ratio (FLC), Absence of clonal cells in bone marrow CR requires, in addition to nCR: Absence of the original monoclonal paraprotein (PPN), Disappearance of soft tissue plasmacytomas nCR is defined as: \< 5% plasma cells in a bone marrow aspirate, No increase in lytic bone lesions VGPR requires: Serum or urine PPN not detectable on electrophoresis OR \>=90% reduction in serum PPN plus urine PPN \<100 mg/24hrs, \>= 50% reduction in the level of serum monoclonal PPN or reduction in 24 hour urinary monoclonal PPN either \>= 90% or to \<200 mg/24 hours in light chain disease, \>= 50% reduction in the size of soft tissue plasmacytomas

Analysis population: Only participants that were evaluable for disease response were analyzed at each time point. Those who had died or experienced disease progression were excluded.

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

1 Year

Analysis denominator · Participants

GroupSource count
Tandem Auto Transplant192
RVD Consolidation209
Lenalidomide Maintenance208

CR or sCR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tandem Auto Transplant97Not reportedNot reportedNot reportedNot reported
RVD Consolidation122Not reportedNot reportedNot reportedNot reported
Lenalidomide Maintenance98Not reportedNot reportedNot reportedNot reported

VGPR or nCR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tandem Auto Transplant56Not reportedNot reportedNot reportedNot reported
RVD Consolidation50Not reportedNot reportedNot reportedNot reported
Lenalidomide Maintenance60Not reportedNot reportedNot reportedNot reported

Worse than VGPR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tandem Auto Transplant39Not reportedNot reportedNot reportedNot reported
RVD Consolidation37Not reportedNot reportedNot reportedNot reported
Lenalidomide Maintenance50Not reportedNot reportedNot reportedNot reported
2 Years

Analysis denominator · Participants

GroupSource count
Tandem Auto Transplant157
RVD Consolidation175
Lenalidomide Maintenance160

CR or sCR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tandem Auto Transplant98Not reportedNot reportedNot reportedNot reported
RVD Consolidation117Not reportedNot reportedNot reportedNot reported
Lenalidomide Maintenance93Not reportedNot reportedNot reportedNot reported

VGPR or nCR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tandem Auto Transplant39Not reportedNot reportedNot reportedNot reported
RVD Consolidation37Not reportedNot reportedNot reportedNot reported
Lenalidomide Maintenance41Not reportedNot reportedNot reportedNot reported

Worse than VGPR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tandem Auto Transplant20Not reportedNot reportedNot reportedNot reported
RVD Consolidation21Not reportedNot reportedNot reportedNot reported
Lenalidomide Maintenance26Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        97
      2. group Id
        OG001
        value
        122
      3. group Id
        OG002
        value
        98
      title
      CR or sCR
    2. measurements
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        50
      3. group Id
        OG002
        value
        60
      title
      VGPR or nCR
    3. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        50
      title
      Worse than VGPR
    denoms
    1. counts
      1. group Id
        OG000
        value
        192
      2. group Id
        OG001
        value
        209
      3. group Id
        OG002
        value
        208
      units
      Participants
    title
    1 Year
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        117
      3. group Id
        OG002
        value
        93
      title
      CR or sCR
    2. measurements
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        41
      title
      VGPR or nCR
    3. measurements
      1. group Id
        OG000
        value
        20
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        26
      title
      Worse than VGPR
    denoms
    1. counts
      1. group Id
        OG000
        value
        157
      2. group Id
        OG001
        value
        175
      3. group Id
        OG002
        value
        160
      units
      Participants
    title
    2 Years
denoms
  1. counts
    1. group Id
      OG000
      value
      247
    2. group Id
      OG001
      value
      254
    3. group Id
      OG002
      value
      257
    units
    Participants
description
The number of participants with very good partial response (VGPR) or better \[complete response (CR), near CR (nCR), and stringent CR (sCR)\] according to the International Uniform Response Criteria will be calculated. The "Worse than VGPR" group includes PR, stable disease, and progressive disease. sCR requires, in addition to CR: Normal free light chain ratio (FLC), Absence of clonal cells in bone marrow CR requires, in addition to nCR: Absence of the original monoclonal paraprotein (PPN), Disappearance of soft tissue plasmacytomas nCR is defined as: \< 5% plasma cells in a bone marrow aspirate, No increase in lytic bone lesions VGPR requires: Serum or urine PPN not detectable on electrophoresis OR \>=90% reduction in serum PPN plus urine PPN \<100 mg/24hrs, \>= 50% reduction in the level of serum monoclonal PPN or reduction in 24 hour urinary monoclonal PPN either \>= 90% or to \<200 mg/24 hours in light chain disease, \>= 50% reduction in the size of soft tissue plasmacytomas
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
COUNT_OF_PARTICIPANTS
population Description
Only participants that were evaluable for disease response were analyzed at each time point. Those who had died or experienced disease progression were excluded.
reporting Status
POSTED
time Frame
1 and 2 years post-randomization
title
Number of Participants With Treatment Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice