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NCT02928029 · OUTCOME

Phase 1: The Number of Subjects With Complete Response (CR) and Very Good Partial Response (VGPR)

Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma · Source last updated 2020-02-26

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 approximately 2 years

What was measured

Determined by International Myeloma Working Group (IMWG) uniform response criteria. CR: Negative immunofixation of serum and urine, disappearance of any soft-tissue plasmacytomas, and \<5% plasma cells in bone marrow; in patients for whom only measurable disease is by serum free light chain (FLC) level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required; 2 consecutive assessments are needed. VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component \<100 mg/24 hours (hrs); in patients for whom only measurable disease is by serum FLC level, \>90% decrease in difference between involved and uninvolved FLC levels, in addition to VGPR criteria, is required; 2 consecutive assessments are needed

Analysis population: The safety analysis set including all participants who received at least one administration of study treatment

Groups in this outcome

Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone

Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX

Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone

Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX

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

Analysis denominator · Participants

GroupSource count
Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone3
Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone4

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Radium-223 Dichloride 33 kBq/kg + Bortezomib and DexamethasoneNANot reportedNot reportedNot reportedParticipants were not evaluable per International Myeloma Working Group (IMWG) uniform response criteria
Radium-223 Dichloride 55 kBq/kg + Bortezomib and DexamethasoneNANot reportedNot reportedNot reportedParticipants were not evaluable per International Myeloma Working Group (IMWG) uniform response criteria
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Participants were not evaluable per International Myeloma Working Group (IMWG) uniform response criteria
        group Id
        OG000
        value
        NA
      2. comment
        Participants were not evaluable per International Myeloma Working Group (IMWG) uniform response criteria
        group Id
        OG001
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Determined by International Myeloma Working Group (IMWG) uniform response criteria. CR: Negative immunofixation of serum and urine, disappearance of any soft-tissue plasmacytomas, and \<5% plasma cells in bone marrow; in patients for whom only measurable disease is by serum free light chain (FLC) level, normal FLC ratio of 0.26 to 1.65 in addition to CR criteria is required; 2 consecutive assessments are needed. VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-component plus urine M-component \<100 mg/24 hours (hrs); in patients for whom only measurable disease is by serum FLC level, \>90% decrease in difference between involved and uninvolved FLC levels, in addition to VGPR criteria, is required; 2 consecutive assessments are needed
groups
  1. description
    Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
    id
    OG000
    title
    Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone
  2. description
    Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX
    id
    OG001
    title
    Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set including all participants who received at least one administration of study treatment
reporting Status
POSTED
time Frame
Up to approximately 2 years
title
Phase 1: The Number of Subjects With Complete Response (CR) and Very Good Partial Response (VGPR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice