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NCT02951819 · OUTCOME

Overall Response Rate (ORR)

A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma · Source last updated 2021-10-08

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
After 4 Cycles of Induction (4 months), at End of Induction (4 to 8 months) and at the End of Maintenance (12 months)

What was measured

ORR: percentage of participants achieved PR or better (PR,VGPR,CR,sCR) per IMWG. CR:negative immunofixation on serum, urine, disappearance of soft tissue plasmacytomas,\<5% PCs in bone marrow(BM). sCR:CR plus normal FLC ratio,absence of clonal cells in BM by immunohistochemistry, immunofluorescence. VGPR:Serum, urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24hours. PR:\>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by \>=90% or to \<200mg/24hours. If serum, urine M-protein unmeasurable, a\>=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum, urine M-protein not measurable, serum free light assay is not measurable,\>=50% reduction in PCs required in place of M-protein,provided baseline bone marrow PCs% \>=30%, if present at baseline, a \>=50% reduction in size of soft tissue plasmacytomas is also required.

Analysis population: Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.

Groups in this outcome

Newly Diagnosed Multiple Myeloma (NDMM)

Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation \[ASCT\] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

Relapsed Multiple Myeloma (RMM)

Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).

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

Analysis denominator · Participants

GroupSource count
Newly Diagnosed Multiple Myeloma (NDMM)86
Relapsed Multiple Myeloma (RMM)14

Reported measurements

After 4 Cycles of Induction
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed Multiple Myeloma (NDMM)79.1Not reported69.087.1Not reported
Relapsed Multiple Myeloma (RMM)71.4Not reported41.991.6Not reported
At the End of Induction
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed Multiple Myeloma (NDMM)87.2Not reported78.393.4Not reported
Relapsed Multiple Myeloma (RMM)78.6Not reported49.295.3Not reported
At the End of Maintenance
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Newly Diagnosed Multiple Myeloma (NDMM)89.5Not reported81.195.1Not reported
Relapsed Multiple Myeloma (RMM)85.7Not reported57.298.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.0
        upper Limit
        87.1
        value
        79.1
      2. group Id
        OG001
        lower Limit
        41.9
        upper Limit
        91.6
        value
        71.4
    title
    After 4 Cycles of Induction
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        78.3
        upper Limit
        93.4
        value
        87.2
      2. group Id
        OG001
        lower Limit
        49.2
        upper Limit
        95.3
        value
        78.6
    title
    At the End of Induction
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        81.1
        upper Limit
        95.1
        value
        89.5
      2. group Id
        OG001
        lower Limit
        57.2
        upper Limit
        98.2
        value
        85.7
    title
    At the End of Maintenance
denoms
  1. counts
    1. group Id
      OG000
      value
      86
    2. group Id
      OG001
      value
      14
    units
    Participants
description
ORR: percentage of participants achieved PR or better (PR,VGPR,CR,sCR) per IMWG. CR:negative immunofixation on serum, urine, disappearance of soft tissue plasmacytomas,\<5% PCs in bone marrow(BM). sCR:CR plus normal FLC ratio,absence of clonal cells in BM by immunohistochemistry, immunofluorescence. VGPR:Serum, urine M-protein detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum M-protein plus urine M-protein level \<100 mg/24hours. PR:\>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by \>=90% or to \<200mg/24hours. If serum, urine M-protein unmeasurable, a\>=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum, urine M-protein not measurable, serum free light assay is not measurable,\>=50% reduction in PCs required in place of M-protein,provided baseline bone marrow PCs% \>=30%, if present at baseline, a \>=50% reduction in size of soft tissue plasmacytomas is also required.
dispersion Type
95% Confidence Interval
groups
  1. description
    Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation \[ASCT\] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
    id
    OG000
    title
    Newly Diagnosed Multiple Myeloma (NDMM)
  2. description
    Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
    id
    OG001
    title
    Relapsed Multiple Myeloma (RMM)
param Type
NUMBER
population Description
Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.
reporting Status
POSTED
time Frame
After 4 Cycles of Induction (4 months), at End of Induction (4 to 8 months) and at the End of Maintenance (12 months)
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice