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NCT02211014 · OUTCOME

Response Assessed According to Guidelines Proposed by the International Myeloma Workshop Consensus Panel and European Group for Blood and Marrow Transplant

An Open-Label, Phase 1b Study of Acalabrutinib With and Without Dexamethasone in Subjects With Multiple Myeloma · Source last updated 2020-07-31

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
From first dose of study drug up to Cycle 12 (48 weeks). Subjects who showed benefit from study drugs were allowed to continue until disease progression

What was measured

Per EBMT: CR, negative immunofixation of serum and urine, disappearance of plasmacytomas and \< 5% plasma cells; Stringent complete response (SCR), CR + normal flow cytometry and absence of clonal plasma cells; Very good partial response (VGPR), Serum and urine M-protein detectable on immunofixation but not on electrophoresis or \> 90% reduction is serum and urine M protein; Partial response (PR), \> 50% reduction in serum M-protein and \> 90% reduction in 24 hour urine M-protein, \> 50% reduction in baseline soft tissue plasmacytoma; Minimal response (MR), 25-49% reduction of serum M-protein and 50-59% reduction in 24 hour urine M-protein, 25-49% reduction in plasmacytomas and no increase in lytic bone lesions; Stable disease (SD), not meeting criteria for CR, VGPR, MR, PR or progressive disease (PD); PD, increase of 25% or more from nadir in serum M-protein, urine M-protein, new or increased bone lesions or plasmacytomas, or hypercalcemia solely attributed to multiple myeloma.

Groups in this outcome

Cohort 1

Acalabrutinib 100 mg twice daily (bid) continuously

Cohort 2

Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly

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 113
Cohort 214

Reported measurements

Source class 1

sCR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
Cohort 20Not reportedNot reportedNot reportedNot reported

CR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
Cohort 20Not reportedNot reportedNot reportedNot reported

VGPR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
Cohort 20Not reportedNot reportedNot reportedNot reported

PR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
Cohort 20Not reportedNot reportedNot reportedNot reported

MR

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 11Not reportedNot reportedNot reportedNot reported
Cohort 22Not reportedNot reportedNot reportedNot reported

SD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 15Not reportedNot reportedNot reportedNot reported
Cohort 26Not reportedNot reportedNot reportedNot reported

PD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 14Not reportedNot reportedNot reportedNot reported
Cohort 21Not reportedNot reportedNot reportedNot reported

NE (not evaluable)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 13Not reportedNot reportedNot reportedNot reported
Cohort 25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      sCR
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      CR
    3. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      VGPR
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      PR
    5. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      title
      MR
    6. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      title
      SD
    7. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        1
      title
      PD
    8. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      title
      NE (not evaluable)
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Per EBMT: CR, negative immunofixation of serum and urine, disappearance of plasmacytomas and \< 5% plasma cells; Stringent complete response (SCR), CR + normal flow cytometry and absence of clonal plasma cells; Very good partial response (VGPR), Serum and urine M-protein detectable on immunofixation but not on electrophoresis or \> 90% reduction is serum and urine M protein; Partial response (PR), \> 50% reduction in serum M-protein and \> 90% reduction in 24 hour urine M-protein, \> 50% reduction in baseline soft tissue plasmacytoma; Minimal response (MR), 25-49% reduction of serum M-protein and 50-59% reduction in 24 hour urine M-protein, 25-49% reduction in plasmacytomas and no increase in lytic bone lesions; Stable disease (SD), not meeting criteria for CR, VGPR, MR, PR or progressive disease (PD); PD, increase of 25% or more from nadir in serum M-protein, urine M-protein, new or increased bone lesions or plasmacytomas, or hypercalcemia solely attributed to multiple myeloma.
groups
  1. description
    Acalabrutinib 100 mg twice daily (bid) continuously
    id
    OG000
    title
    Cohort 1
  2. description
    Acalabrutinib 100 mg bid continuously and 40 mg dexamethasone once weekly
    id
    OG001
    title
    Cohort 2
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From first dose of study drug up to Cycle 12 (48 weeks). Subjects who showed benefit from study drugs were allowed to continue until disease progression
title
Response Assessed According to Guidelines Proposed by the International Myeloma Workshop Consensus Panel and European Group for Blood and Marrow Transplant
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice