NCT00054353 · ADVERSE EVENTS

Adverse events

Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2017-10-16

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Related Donor PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s	4 / 12	9 / 12	4 / 12
Unrelated Donor PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s	1 / 4	2 / 4	1 / 4

Group identifiers: EG000: Related Donor · EG001: Unrelated Donor

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Respiratory failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
3
num At Risk
12
num Events
3
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Bone marrow hypocellular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Generalized muscle weaknes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Hypotension

Complete source fields

event Groups

deaths Num Affected
4
deaths Num At Risk
12
description
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s
id
EG000
other Num Affected
9
other Num At Risk
12
serious Num Affected
4
serious Num At Risk
12
title
Related Donor
deaths Num Affected
1
deaths Num At Risk
4
description
PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s
id
EG001
other Num Affected
2
other Num At Risk
4
serious Num Affected
1
serious Num At Risk
4
title
Unrelated Donor

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
3
num At Risk
12
num Events
3
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Bone marrow hypocellular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Generalized muscle weaknes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Hypotension

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Adult respiratory distress syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Blood bilirubin increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
4
num Events
1
term
Respiratory failure

time Frame

AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

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Preserved source evidence · Not medical advice