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NCT02375555 · OUTCOME

Successful Stem Cell Mobilization (SC Mob) Rate

Study of Bortezomib,Lenalidomide,Dexamethasone & Elotuzumab in Newly Diagnosed MM · Source last updated 2024-10-01

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
The most distant time of stem cell mobilization from time of registration is 21.4 weeks with a median of 15.14 weeks.

What was measured

Successful SC Mob defined as the proportion of participants with the ability to collect a total of at least 2\*10\^6 CD34+ cells/kg.

Analysis population: The analysis population is comprised of participants who underwent stem cell mobilization after completing 4 cycles of induction therapy.

Groups in this outcome

Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone

Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. * Elotuzumab will be administered by intravenous (IV) infusion * Bortezomib as a subcutaneous injection * Lenalidomide single daily oral dose * Dexamethasone as oral tablets and IV infusion * Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy. The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.

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

Analysis denominator · Participants

GroupSource count
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone31

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone0.968Not reported0.8330.999Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.833
        upper Limit
        0.999
        value
        0.968
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Successful SC Mob defined as the proportion of participants with the ability to collect a total of at least 2\*10\^6 CD34+ cells/kg.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. * Elotuzumab will be administered by intravenous (IV) infusion * Bortezomib as a subcutaneous injection * Lenalidomide single daily oral dose * Dexamethasone as oral tablets and IV infusion * Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy. The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.
    id
    OG000
    title
    Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone
param Type
NUMBER
population Description
The analysis population is comprised of participants who underwent stem cell mobilization after completing 4 cycles of induction therapy.
reporting Status
POSTED
time Frame
The most distant time of stem cell mobilization from time of registration is 21.4 weeks with a median of 15.14 weeks.
title
Successful Stem Cell Mobilization (SC Mob) Rate
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice