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NCT01246063 · OUTCOME

Median Overall Survival

Carfilzomib, Pegylated Liposomal Doxorubicin Hydrochloride, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2019-04-08

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Completion of follow-up (median of 23.3 months)

Groups in this outcome

Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)

Dose Level 0: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.

Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)

Dose Level 1: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.

Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)

Dose Level 2: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.

Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)

Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.

Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)

Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.

Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)

Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.

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

Analysis denominator · Participants

GroupSource count
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)3
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)4
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)4
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)5
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)7
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)17

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)25.490Not reported.00060.025Not reported
Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)18.780Not reported1.49336.067Not reported
Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)11.610Not reported.00023.889Not reported
Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)32.340Not reported.00086.811Not reported
Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)18.720Not reported8.66028.780Not reported
Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)NANot reportedNANAThe median overall survival was not reached in the follow-up time period.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .000
        upper Limit
        60.025
        value
        25.490
      2. group Id
        OG001
        lower Limit
        1.493
        upper Limit
        36.067
        value
        18.780
      3. group Id
        OG002
        lower Limit
        .000
        upper Limit
        23.889
        value
        11.610
      4. group Id
        OG003
        lower Limit
        .000
        upper Limit
        86.811
        value
        32.340
      5. group Id
        OG004
        lower Limit
        8.660
        upper Limit
        28.780
        value
        18.720
      6. comment
        The median overall survival was not reached in the follow-up time period.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      17
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Dose Level 0: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (27 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
    id
    OG000
    title
    Phase I - Part 1 Dose Level 0 (Carfilzomib 20/27 mg/m^2)
  2. description
    Dose Level 1: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (36 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
    id
    OG001
    title
    Phase I - Part 1 Dose Level 1 (Carfilzomib 20/36 mg/m^2)
  3. description
    Dose Level 2: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (45 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
    id
    OG002
    title
    Phase I - Part 1 Dose Level 2 (Carfilzomib 20/45 mg/m^2)
  4. description
    Dose Level 3: Carfilzomib IV (20 mg/m2) D1\&D2 of C1 and carfilzomib IV (56 mg/m2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m2)D8 C1-6.
    id
    OG003
    title
    Phase I - Part 1 Dose Level 3 (Carfilzomib 20/56 mg/^2)
  5. description
    Cohort 0: Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
    id
    OG004
    title
    Phase I-Part 2 Cohort 0 (Carfilzomib 56 mg/m^2+Dexamethasone)
  6. description
    Carfilzomib IV (56 mg/\^2 - Phase 1 Part 1) D1, D2, D8, D9, D15, D16 C1-6. Carfilzomib IV (56 mg/m\^2 - Phase 1 Part 1) D1, D8, D15, D22 C7 and subsequent cycles. PLD IV (30 mg/m\^2 - Phase 1 Part 1) D8 of each cycle. Dexamethasone 20 mg IV or PO same schedule as carfilzomib.
    id
    OG005
    title
    Phase 2 (Carfilzomib 56 mg/m^2+ Dexamethasone)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Completion of follow-up (median of 23.3 months)
title
Median Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice