TriangleNCT00075478 · STUDY IN CONTEXT
Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
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
Percentage of patients surviving as estimated by Kaplan-Meier.
Percentage of NRM as estimated by cumulative incidence methods with competing risks
Percentage of relapse estimated by cumulative incidence methods
Percentage of death following relapse/progression, estimated by cumulative incidence methods
Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods
Percentage patients with chronic extensive GVHD, estimated by cumulative incidence methods
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-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- trial label
- Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
- 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
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0000
- source section id
- NCT00075478-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- Percentage of patients surviving as estimated by Kaplan-Meier.
- time origin
- 3 years after transplant
- 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-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0001
- source section id
- NCT00075478-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Non-relapse Mortality
- endpoint definition
- Percentage of NRM as estimated by cumulative incidence methods with competing risks
- time origin
- 3 years after transplant
- 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-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0002
- source section id
- NCT00075478-om-0002
- source outcome index
- 2
- endpoint
- Incidence of Relapse/Progression
- endpoint definition
- Percentage of relapse estimated by cumulative incidence methods
- time origin
- 3 years after transplant
- 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-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0003
- source section id
- NCT00075478-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Relapse-related Mortality
- endpoint definition
- Percentage of death following relapse/progression, estimated by cumulative incidence methods
- time origin
- 3 years after transplant
- 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-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0004
- source section id
- NCT00075478-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Grades II-IV Acute GVHD
- endpoint definition
- Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods
- time origin
- 120 days after transplant
- 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-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0005
- source section id
- NCT00075478-om-0005
- source outcome index
- 5
- endpoint
- Incidence of Chronic Extensive GVHD
- endpoint definition
- Percentage patients with chronic extensive GVHD, estimated by cumulative incidence methods
- time origin
- 3 years after transplant
- 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-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II (TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II (TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm II (TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI fludarabine phosphate: Given IV mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 41
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm II (TBI, Transplant, GVHD Prophylaxis)
- regimen
- Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins. total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO peripheral blood stem cell transplantation: Undergo transplantation
- analyzed count
- 44
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00075478-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- harm key
- EG000
- source section id
- NCT00075478-ae
- event group key
- EG000
- event group label
- Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
- serious affected
- 8
- serious at risk
- 41
- other affected
- 34
- other at risk
- 41
- frequency threshold
- 0
- collection period
- Source null
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-multiple-myeloma-sarclisa-escena-9eb42ed1
- nct id
- NCT00075478
- harm key
- EG001
- source section id
- NCT00075478-ae
- event group key
- EG001
- event group label
- Arm II (TBI, Transplant, GVHD Prophylaxis)
- serious affected
- 5
- serious at risk
- 44
- other affected
- 20
- other at risk
- 44
- frequency threshold
- 0
- collection period
- Source null
- 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