Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Number of patients alive at 1 year after transplant.

Source null

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secondary · POSTED

Determine the incidence of transplant-related mortality at 6 months after UCBT

Source null

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secondary · POSTED

Determine the incidence of platelet engraftment (platelet recovery \>50,000/uL) at 6 months after UCBT.

Source null

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secondary · POSTED

Determine the incidence of neutrophil engraftment at day 42 after UCBT Patients diagnosed with graft failure (failure of absolute neutrophil count ANC \> 5 x 10\^8/L of donor origin by day +42)

Source null

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secondary · POSTED

Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Source null

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secondary · POSTED

Determine the incidence of chronic GVHD at 1 year after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-multiple-myeloma-darzalex-faspro-f9050675
nct id: NCT00309842
trial label: Myeloablative Umbilical Cord Blood Transplantation in Hematological Diseases
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0000
source section id
NCT00309842-om-0000
source outcome index
0
endpoint
Number of Participants Who Were Alive at 1 Year Transplant Overall Survival
endpoint definition
Number of patients alive at 1 year after transplant.
time origin
at 1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0001
source section id
NCT00309842-om-0001
source outcome index
1
endpoint
Number of Participants Who Died Due to Transplant
endpoint definition
Determine the incidence of transplant-related mortality at 6 months after UCBT
time origin
At Month 6
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0002
source section id
NCT00309842-om-0002
source outcome index
2
endpoint
Number of Participants With Platelet Engraftment
endpoint definition
Determine the incidence of platelet engraftment (platelet recovery \>50,000/uL) at 6 months after UCBT.
time origin
6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0003
source section id
NCT00309842-om-0003
source outcome index
3
endpoint
Number of Participants With Neutrophil Engraftment
endpoint definition
Determine the incidence of neutrophil engraftment at day 42 after UCBT Patients diagnosed with graft failure (failure of absolute neutrophil count ANC \> 5 x 10\^8/L of donor origin by day +42)
time origin
Day 42
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0004
source section id
NCT00309842-om-0004
source outcome index
4
endpoint
Number of Participants With Acute Graft-Versus-Host Disease
endpoint definition
Determine the incidence of grade II-IV and grade III-IV acute graft-versus-host disease (GVHD) at day 100 after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria following Przepiorka et al, 1995, Consensus Clinical Stage and Grade of Acute GVHD. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
time origin
Day 100
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0005
source section id
NCT00309842-om-0005
source outcome index
5
endpoint
Number of Participants With Chronic Graft-Versus-Host Disease
endpoint definition
Determine the incidence of chronic GVHD at 1 year after UCBT. Patients will be staged weekly between days 0 and 100 after transplantation using standard criteria. Patients will be assigned an overall GVHD score based on extent of skin rash, volume of diarrhea and maximum bilirubin level.
time origin
Year 1
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0000
arm key
OG000
arm label
Unrelated UCBT for Blood Cancers
regimen
Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
analyzed count
212
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309842-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0001
arm key
OG000
arm label
Unrelated UCBT for Blood Cancers
regimen
Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
analyzed count
212
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309842-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0002
arm key
OG000
arm label
Unrelated UCBT for Blood Cancers
regimen
Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
analyzed count
212
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309842-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0003
arm key
OG000
arm label
Unrelated UCBT for Blood Cancers
regimen
Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
analyzed count
212
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309842-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0004
arm key
OG000
arm label
Unrelated UCBT for Blood Cancers
regimen
Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
analyzed count
212
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309842-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
outcome key
om-0005
arm key
OG000
arm label
Unrelated UCBT for Blood Cancers
regimen
Patients undergoing unrelated umbilical cord blood transplantation (UCBT) for hematologic malignancies treated with myeloablative preparative regimen comprising fludarabine phosphate, mycophenolate mofetil, filgrastim, cyclophosphamide, cyclosporine and fractionated total-body irradiation.
analyzed count
212
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00309842-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-darzalex-faspro-f9050675
nct id
NCT00309842
harm key
EG000
source section id
NCT00309842-ae
event group key
EG000
event group label
Unrelated UCBT for Blood Cancers
serious affected
92
serious at risk
212
other affected
187
other at risk
212
frequency threshold
5
collection period
Upto 2 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice