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NCT01447914 · OUTCOME

Overall Response Rate (ORR)

Tivantinib in Treating Patients With Relapsed, or Relapsed and Refractory Multiple Myeloma · Source last updated 2019-08-28

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 30 days

What was measured

ORR using International Myeloma Working Group Response Criteria, achieve at least a partial response (PR) or better: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR): CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 hour; Stable Disease (SD): Not CR, VGPR, PR or progressive disease; Progressive Disease (PD):\>25% from lowest value Serum and/or Urine M-component, new lesions or soft tissue plasmacytomas, or hypercalcemia.

Analysis population: Proportion of participants reported on an intent-to-treat basis.

Groups in this outcome

Tivantinib Treatment

Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)

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

Analysis denominator · Participants

GroupSource count
Tivantinib Treatment16

Reported measurements

Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment4Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment7Not reportedNot reportedNot reportedNot reported
Not Evaluable
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tivantinib Treatment5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Stable Disease
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Progressive Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    units
    Participants
description
ORR using International Myeloma Working Group Response Criteria, achieve at least a partial response (PR) or better: Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR): CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90%; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 hour; Stable Disease (SD): Not CR, VGPR, PR or progressive disease; Progressive Disease (PD):\>25% from lowest value Serum and/or Urine M-component, new lesions or soft tissue plasmacytomas, or hypercalcemia.
groups
  1. description
    Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
    id
    OG000
    title
    Tivantinib Treatment
param Type
NUMBER
population Description
Proportion of participants reported on an intent-to-treat basis.
reporting Status
POSTED
time Frame
Up to 30 days
title
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice