NCT01842308 · OUTCOME

Adverse Event Rate, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Carfilzomib and Melphalan Before Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2020-09-01

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: Up to 5 years

What was measured

These results are reported in the adverse events section. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.

Analysis population: All patients that received treatment

Groups in this outcome

Phase 1: Dose Level 3

CONDITIONING: Patients receive 56 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV

Phase 1: Dose Level 2

CONDITIONING: Patients receive 45 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV

Phase 1: Dose Level 1

CONDITIONING: Patients receive 36 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV

Phase 1: Dose Level 0

CONDITIONING: Patients receive 27 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV

Phase 2: Dose Level 3

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 1: Dose Level 3	6
Phase 1: Dose Level 2	3
Phase 1: Dose Level 1	3
Phase 1: Dose Level 0	2
Phase 2: Dose Level 3	35

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Dose Level 3	6	Not reported	Not reported	Not reported	Not reported
Phase 1: Dose Level 2	3	Not reported	Not reported	Not reported	Not reported
Phase 1: Dose Level 1	3	Not reported	Not reported	Not reported	Not reported
Phase 1: Dose Level 0	2	Not reported	Not reported	Not reported	Not reported
Phase 2: Dose Level 3	35	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
35

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
35
units
Participants

description

groups

description
CONDITIONING: Patients receive 56 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
id
OG000
title
Phase 1: Dose Level 3
description
CONDITIONING: Patients receive 45 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
id
OG001
title
Phase 1: Dose Level 2
description
CONDITIONING: Patients receive 36 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
id
OG002
title
Phase 1: Dose Level 1
description
CONDITIONING: Patients receive 27 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
id
OG003
title
Phase 1: Dose Level 0
description
CONDITIONING: Patients receive 56 mg/m\^2 carfilzomib IV over 30 minutes on days -6, -5, -2, and -1. Patients also receive 100mg/m\^2 melphalan IV over 1 hour on days -4 and -3. TRANSPLANT: Patients undergo autologous stem cell transplant on day 0. Autologous Bone Marrow Transplantation: Undergo autologous stem cell transplant. Autologous Hematopoietic Stem Cell. Transplantation: Undergo autologous stem cell transplant, Carfilzomib: Given IV. Laboratory Biomarker Analysis: Correlative studies, Melphalan: Given IV
id
OG004
title
Phase 2: Dose Level 3

param Type

COUNT_OF_PARTICIPANTS

population Description

All patients that received treatment

reporting Status

POSTED

time Frame

Up to 5 years

title

Adverse Event Rate, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice