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NCT02716805 · OUTCOME

Number of Subjects With Best Response According to International Myeloma Working Group (IMWG) Consensus Criteria

Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant · Source last updated 2022-10-12

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
Up to 14 months

What was measured

Response was evaluated by appropriate imaging and myeloma serum/urine tests at the start of Cycle 1 and end of study, with response categorized per IMWG consensus criteria, as follows: stringent complete response (sCR) - CR criteria + normal free light chain (FLC) ratio + no clonal cells in bone marrow; CR - negative immunofixation on serum/urine + no soft tissue plasmacytomas + \<5% plasma cells in bone marrow; very good partial response (VGPR) - serum/urine M-protein detectable by immunofixation but not electrophoresis OR ≥90% reduction in serum M-protein + urine \<100 mg/24h; PR - ≥50% and ≥90% (or \<200 mg/24h) reduction of serum + urine M-protein, respectively; progressive disease - increase of ≥25% serum and/or urine M-component, increase of \>10 mg/dL in involved and uninvolved FLC levels, bone marrow plasma cells ≥10%, new or larger lesions, or corrected serum calcium \>11.5 mg/dL or 2.65 mmol/L \[Rajkumar et al. Blood 2011;117:4691-5; Durie et al. Leukemia 2006;20:1467-73\].

Analysis population: All subjects who received at least 1 dose of study treatment and underwent at least 1 post-baseline disease assessment.

Groups in this outcome

Cohort 1

"Late" post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)

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

Analysis denominator · Participants

GroupSource count
Cohort 14

Reported measurements

sCR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 11Not reportedNot reportedNot reportedNot reported
VGPR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 12Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    sCR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    VGPR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
Response was evaluated by appropriate imaging and myeloma serum/urine tests at the start of Cycle 1 and end of study, with response categorized per IMWG consensus criteria, as follows: stringent complete response (sCR) - CR criteria + normal free light chain (FLC) ratio + no clonal cells in bone marrow; CR - negative immunofixation on serum/urine + no soft tissue plasmacytomas + \<5% plasma cells in bone marrow; very good partial response (VGPR) - serum/urine M-protein detectable by immunofixation but not electrophoresis OR ≥90% reduction in serum M-protein + urine \<100 mg/24h; PR - ≥50% and ≥90% (or \<200 mg/24h) reduction of serum + urine M-protein, respectively; progressive disease - increase of ≥25% serum and/or urine M-component, increase of \>10 mg/dL in involved and uninvolved FLC levels, bone marrow plasma cells ≥10%, new or larger lesions, or corrected serum calcium \>11.5 mg/dL or 2.65 mmol/L \[Rajkumar et al. Blood 2011;117:4691-5; Durie et al. Leukemia 2006;20:1467-73\].
groups
  1. description
    "Late" post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)
    id
    OG000
    title
    Cohort 1
param Type
COUNT_OF_PARTICIPANTS
population Description
All subjects who received at least 1 dose of study treatment and underwent at least 1 post-baseline disease assessment.
reporting Status
POSTED
time Frame
Up to 14 months
title
Number of Subjects With Best Response According to International Myeloma Working Group (IMWG) Consensus Criteria
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice