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NCT02928029 · OUTCOME

Phase 1: MTD/RP2D Determined by the Incidence of DLTs

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
NUMBER
Unit
KBq/kg
Interval / dispersion
Not reported
Time frame
From the start of study medication through 3 weeks after administration of the second dose of radium-223 dichloride, assessed up to 9 weeks

What was measured

Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the severity grade

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 KBq/kg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Radium-223 Dichloride 33 kBq/kg + Bortezomib and DexamethasoneNANot reportedNot reportedNot reportedThis study was stopped prior to the MTD being defined. Accordingly, there was no RP2D determined
Radium-223 Dichloride 55 kBq/kg + Bortezomib and DexamethasoneNANot reportedNot reportedNot reportedThis study was stopped prior to the MTD being defined. Accordingly, there was no RP2D determined
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        This study was stopped prior to the MTD being defined. Accordingly, there was no RP2D determined
        group Id
        OG000
        value
        NA
      2. comment
        This study was stopped prior to the MTD being defined. Accordingly, there was no RP2D determined
        group Id
        OG001
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the severity grade
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
NUMBER
population Description
The safety analysis set including all participants who received at least one administration of study treatment
reporting Status
POSTED
time Frame
From the start of study medication through 3 weeks after administration of the second dose of radium-223 dichloride, assessed up to 9 weeks
title
Phase 1: MTD/RP2D Determined by the Incidence of DLTs
type
PRIMARY
unit Of Measure
KBq/kg

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

Preserved source evidence · Not medical advice