NCT00309842 · STUDY IN CONTEXT
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
Number of patients alive at 1 year after transplant.
Determine the incidence of transplant-related mortality at 6 months after UCBT
Determine the incidence of platelet engraftment (platelet recovery \>50,000/uL) at 6 months after UCBT.
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)
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.
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.
Reported safety
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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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-blenrep-90ee8111
- 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
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