NCT00792142 · OUTCOME

Number of Participants With Adverse Events

Bortezomib, Thalidomide, and Dexamethasone After Melphalan and Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma · Source last updated 2021-08-19

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: After 4 months of maintenance therapy

What was measured

All grade 3 and above treatment-related adverse events (AEs) during bortezomib/dexamethasone treatment cycles.

Analysis population: Five patients did not start the maintenance phase of the study because of neurotoxicity (n=3), thrombocytopenia (n=1), or withdrawal of consent (n=1).

Groups in this outcome

Treatment (Stem Cell Transplant, Maintenance Treatment)

Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.

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
Treatment (Stem Cell Transplant, Maintenance Treatment)	40

Reported measurements

Leukopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	1	Not reported	Not reported	Not reported	Not reported

Lymphopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	13	Not reported	Not reported	Not reported	Not reported

Neutropenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	2	Not reported	Not reported	Not reported	Not reported

Thrombocytopenia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	1	Not reported	Not reported	Not reported	Not reported

Cataract

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	1	Not reported	Not reported	Not reported	Not reported

Fatigue

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	2	Not reported	Not reported	Not reported	Not reported

Upper respiratory infection

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	1	Not reported	Not reported	Not reported	Not reported

Anxiety

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	1	Not reported	Not reported	Not reported	Not reported

Pain in extremity

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	1	Not reported	Not reported	Not reported	Not reported

Sinus bradycardia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	1	Not reported	Not reported	Not reported	Not reported

Hyperglycemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	4	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Stem Cell Transplant, Maintenance Treatment)	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
title
Leukopenia
categories
measurements
group Id
OG000
value
13
title
Lymphopenia
categories
measurements
group Id
OG000
value
2
title
Neutropenia
categories
measurements
group Id
OG000
value
1
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
1
title
Cataract
categories
measurements
group Id
OG000
value
2
title
Fatigue
categories
measurements
group Id
OG000
value
1
title
Upper respiratory infection
categories
measurements
group Id
OG000
value
1
title
Anxiety
categories
measurements
group Id
OG000
value
1
title
Pain in extremity
categories
measurements
group Id
OG000
value
1
title
Sinus bradycardia
categories
measurements
group Id
OG000
value
4
title
Hyperglycemia
categories
measurements
group Id
OG000
value
3
title
Hypophosphatemia

denoms

counts
group Id
OG000
value
40
units
Participants

description

All grade 3 and above treatment-related adverse events (AEs) during bortezomib/dexamethasone treatment cycles.

groups

description
Patients receive high-dose melphalan IV 200mg/m\^2 over 30 minutes on days -2 and -1 and undergo autologous peripheral blood stem cell transplantation (Minimum dose of 2 X 10(6) CD34 + cells/kg ) on day 0. Patients receive filgrastim 5ug/kg IV or SQ beginning on day 5 and continuing until blood counts recover. Beginning 4 to 8 weeks after transplantation, patients receive maintenance therapy comprising 1.3 mg/m\^2 of bortezomib IV on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive 40mg of oral dexamethasone on days 1 to 4. Treatment with dexamethasone repeats every month for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of bortezomib, patients receive 50mg/day of oral thalidomide once daily until disease progression.
id
OG000
title
Treatment (Stem Cell Transplant, Maintenance Treatment)

param Type

COUNT_OF_PARTICIPANTS

population Description

Five patients did not start the maintenance phase of the study because of neurotoxicity (n=3), thrombocytopenia (n=1), or withdrawal of consent (n=1).

reporting Status

POSTED

time Frame

After 4 months of maintenance therapy

title

Number of Participants With Adverse Events

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice