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NCT01999335 · OUTCOME

Number of Participants With Dose-limiting Toxicities (DLTs)

A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma · Source last updated 2021-04-27

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
Cycle 1, 28 days

What was measured

DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, defined as any of the following treatment-related events occurring within 4 weeks after the first dose of therapy: Any grade ≥ 3 nonhematologic toxicity, except: Grade 3 asymptomatic electrolyte abnormalities or hypophosphatemia for \< 24 hours; Grade 3 nausea, vomiting or diarrhea unless for \> 3 days despite optimal supportive care; Grade 3 fatigue for \< 14 days; Grade ≥ 3 hyperglycemia or toxicity attributed to dexamethasone and Grade ≥ 3 rash attributed to pomalidomide. Hematologic toxicities: * Grade 4 neutropenia: Absolute neutrophil count \< 0.5 × 10\^9/L for ≥ 7 days despite adequate growth factor support; febrile neutropenia * Thrombocytopenia: Grade 4 for ≥ 7 days, or Grade 4 for \< 7 days with grade 2 clinically significant bleeding or \< 10,000 platelets requiring transfusion, or Grade 3 with clinically significant bleeding or requiring platelet transfusion.

Analysis population: Participants who received at least 1 dose of any study drug

Groups in this outcome

Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone

Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.

Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone

Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.

Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone

Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.

Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone

Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.

Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase

Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone3
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone1
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone7
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone10
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase10

Reported measurements

Any dose-limiting toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone2Not reportedNot reportedNot reportedNot reported
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase0Not reportedNot reportedNot reportedNot reported
Gastric hemorrhage
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase0Not reportedNot reportedNot reportedNot reported
Abdominal distension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase0Not reportedNot reportedNot reportedNot reported
Cognitive disorder
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase0Not reportedNot reportedNot reportedNot reported
Mucosal inflammation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone1Not reportedNot reportedNot reportedNot reported
Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Any dose-limiting toxicity
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Gastric hemorrhage
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Abdominal distension
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Cognitive disorder
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
    title
    Mucosal inflammation
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      10
    units
    Participants
description
DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, defined as any of the following treatment-related events occurring within 4 weeks after the first dose of therapy: Any grade ≥ 3 nonhematologic toxicity, except: Grade 3 asymptomatic electrolyte abnormalities or hypophosphatemia for \< 24 hours; Grade 3 nausea, vomiting or diarrhea unless for \> 3 days despite optimal supportive care; Grade 3 fatigue for \< 14 days; Grade ≥ 3 hyperglycemia or toxicity attributed to dexamethasone and Grade ≥ 3 rash attributed to pomalidomide. Hematologic toxicities: * Grade 4 neutropenia: Absolute neutrophil count \< 0.5 × 10\^9/L for ≥ 7 days despite adequate growth factor support; febrile neutropenia * Thrombocytopenia: Grade 4 for ≥ 7 days, or Grade 4 for \< 7 days with grade 2 clinically significant bleeding or \< 10,000 platelets requiring transfusion, or Grade 3 with clinically significant bleeding or requiring platelet transfusion.
groups
  1. description
    Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Oprozomib 150 mg 5/14 + Pomalidomide 4 mg + Dexamethasone
  2. description
    Participants received oprozomib 150 mg once daily on days 1 to 5 and days 15 to 19 (5/14 schedule) of each 28-day treatment cycle, in combination with pomalidomide 2 mg/day on days 1 to 21 and dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Oprozomib 150 mg 5/14 + Pomalidomide 2 mg + Dexamethasone
  3. description
    Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG002
    title
    Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
  4. description
    Participants received oprozomib 240 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG003
    title
    Oprozomib 240 mg 2/7 + Pomalidomide 4 mg + Dexamethasone
  5. description
    Participants received oprozomib 210 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 (2/7 schedule) of each 28-day treatment cycle, in combination with pomalidomide 4 mg on days 1 through 21 and dexamethasone 20 mg/day on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle until disease progression or unacceptable toxicity.
    id
    OG004
    title
    Oprozomib 210 mg 2/7 + Pomalidomide 4 mg + Dexamethasone: Expansion Phase
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who received at least 1 dose of any study drug
reporting Status
POSTED
time Frame
Cycle 1, 28 days
title
Number of Participants With Dose-limiting Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice