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NCT01246063 · OUTCOME

Maximum Tolerated Dose (MTD) of Dexamethasone (Phase I - Part 2).

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
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
28 days (completion of first cycle of all Phase I - Part 2 patients)

What was measured

-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.

Analysis population: Participants enrolled in the Phase I - Part 2 portion of this study were the only evaluable participants for this outcome measure.

Groups in this outcome

Phase I - Part 1

Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.

Phase I - Part 2

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 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 10
Phase I - Part 27
Phase 20

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - Part 220Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      0
    units
    Participants
description
-MTD is the maximum tolerated dose level tested unless dose limiting toxicity (DLT) are observed during Cycle 1. If DLT is observed, MTD will be the next lower dose level.
groups
  1. description
    Dose Level 0: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (27 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (27 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (27 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 1: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (36 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (36 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (36 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 2: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (45 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (45 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (45 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6. Dose Level 3: Carfilzomib IV (20 mg/m\^2) D1\&D2 of C1 and carfilzomib IV (56 mg/m\^2)D8, D9, D15, D16 of C1. Carfilzomib IV (56 mg/m\^2) D1, D2, D8, D9, D15, D16 C2-6. Carfilzomib IV (56 mg/m\^2)D1, D2, D8, D15, D22 C7+. PLD IV (30 mg/m\^2)D8 C1-6.
    id
    OG000
    title
    Phase I - Part 1
  2. 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
    OG001
    title
    Phase I - Part 2
  3. 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
    OG002
    title
    Phase 2
param Type
NUMBER
population Description
Participants enrolled in the Phase I - Part 2 portion of this study were the only evaluable participants for this outcome measure.
reporting Status
POSTED
time Frame
28 days (completion of first cycle of all Phase I - Part 2 patients)
title
Maximum Tolerated Dose (MTD) of Dexamethasone (Phase I - Part 2).
type
PRIMARY
unit Of Measure
mg

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Preserved source evidence · Not medical advice