NCT00325416 · OUTCOME

Phase II Participants - Overall Response Rate

Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma. · Source last updated 2018-03-14

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

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Phase II - Phase start at 62 months up to 120 months

What was measured

Re-evaluation of participants who had responsive disease prior to transplant. All changes in monoclonal protein and immunoglobulins will be referenced to those levels obtained immediately prior to cyclophosphamide priming chemotherapy. Complete Response (CR): A CR will be defined as the disappearance of the monoclonal protein by immunofixation studies of serum and urine (100x concentrate) and less than or equal to 5% plasma cells in a bone marrow aspirate. Partial Response (PR): 50% - 74% decrease in the measurable monoclonal protein (M-component from an SPEP and/or UPEP with immunofixation).

Analysis population: Phase II (treatment at MTD) participants with responsive disease prior to transplant.

Groups in this outcome

Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue

Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0

Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue

Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0

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
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue	23
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue	28

Reported measurements

Overall Response Rate

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue	65	Not reported	Not reported	Not reported	Not reported
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue	57	Not reported	Not reported	Not reported	Not reported

Complete Response Rate

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue	26	Not reported	Not reported	Not reported	Not reported
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue	18	Not reported	Not reported	Not reported	Not reported

Partial Response Rate

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue	39	Not reported	Not reported	Not reported	Not reported
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue	39	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
65
group Id
OG001
value
57
title
Overall Response Rate
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
18
title
Complete Response Rate
categories
measurements
group Id
OG000
value
39
group Id
OG001
value
39
title
Partial Response Rate

denoms

counts
group Id
OG000
value
23
group Id
OG001
value
28
units
Participants

description

groups

description
Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0
id
OG000
title
Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue
description
Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0
id
OG001
title
Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue

param Type

NUMBER

population Description

Phase II (treatment at MTD) participants with responsive disease prior to transplant.

reporting Status

POSTED

time Frame

Phase II - Phase start at 62 months up to 120 months

title

Phase II Participants - Overall Response Rate

type

PRIMARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice