NCT01246063 · OUTCOME

Maximum Tolerated Dose (MTD) of Carfilzomib and Pegylated Liposomal Doxorubicin (Phase I - Part 1).

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/m^2
Interval / dispersion: Not reported
Time frame: 28 days (completion of first cycle of all Phase I - Part 1 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. * Please note that the maximum tolerated dose of carfilzomib and pegylated liposomal doxorubicin was not reached. The data below is the recommended dosage for further studies.

Analysis population: Participants enrolled in the Phase I - Part 1 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

Group	Source count
Phase I - Part 1	16
Phase I - Part 2	0
Phase 2	0

Reported measurements

Carfilzomib Recommended Dose

Values in mg/m^2 · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I - Part 1	56	Not reported	Not reported	Not reported	Not reported

Pegylated liposomal doxorubicin recommended dose

Values in mg/m^2 · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I - Part 1	30	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
56
title
Carfilzomib Recommended Dose
categories
measurements
group Id
OG000
value
30
title
Pegylated liposomal doxorubicin recommended dose

denoms

counts
group Id
OG000
value
16
group Id
OG001
value
0
group Id
OG002
value
0
units
Participants

description

groups

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
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
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 1 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 1 patients)

title

Maximum Tolerated Dose (MTD) of Carfilzomib and Pegylated Liposomal Doxorubicin (Phase I - Part 1).

type

PRIMARY

unit Of Measure

mg/m^2

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Preserved source evidence · Not medical advice