TriangleNCT00615589 · STUDY IN CONTEXT
Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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
The primary objective is overall survival, one year from the time of transplant.
One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a \>25% increase in serum monoclonal paraprotein, a \>25% increase in 24-hour urinary light chain excretion, a \>25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.
Percentage of Patients With Treatment Related Mortality (TRM)
Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed. Acute GVHD Grading: Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, \>1500ml/day diarrhea Stage IV - Skin, bullae; Liver, \>15mg/dl bilirubin; Gut, pain +/- ileus
Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.
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-plasma-cell-neoplasms
- nct id
- NCT00615589
- trial label
- Stem Cell Transplantation To Treat High Risk Multiple Myeloma With Reduced Toxicity Myeloablative Conditioning Regimen
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- 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
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0000
- source section id
- NCT00615589-om-0000
- source outcome index
- 0
- endpoint
- The Percentage of Patients Alive 1 Year Post Transplant
- endpoint definition
- The primary objective is overall survival, one year from the time of transplant.
- time origin
- 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-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0001
- source section id
- NCT00615589-om-0001
- source outcome index
- 1
- endpoint
- The Percentage of Patients Free From Progression at 1 Year
- endpoint definition
- One of the secondary outcomes that will be measured is progression free survival at 1 Year. Progressive Disease (PD) is defined as a \>25% increase in serum monoclonal paraprotein, a \>25% increase in 24-hour urinary light chain excretion, a \>25% increase in plasma cells in bone marrow aspirate, an increase in the size or the development of new bone lesions/soft tissue plasmacytomas, or the development of hypercalcemia.
- time origin
- 1 Year
- 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-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0002
- source section id
- NCT00615589-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Patients With Treatment Related Mortality (TRM)
- endpoint definition
- Percentage of Patients With Treatment Related Mortality (TRM)
- time origin
- 100 days, one-year
- 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-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0003
- source section id
- NCT00615589-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Patients With Acute and Chronic Graft Versus Host Disease (GVHD)
- endpoint definition
- Incidence of acute (Stage II-IV and Stage III-IV) and chronic GVHD (any stage) were analyzed. Acute GVHD Grading: Stage II - Skin, 25-50% BSA (Body Surface Area); Liver, 3.1-6mg/dl bilirubin; Gut, 1000-1500ml/day diarrhea Stage III - Skin, generalized erythroderma; Liver, 6.1-15mg/dl bilirubin; Gut, \>1500ml/day diarrhea Stage IV - Skin, bullae; Liver, \>15mg/dl bilirubin; Gut, pain +/- ileus
- time origin
- 100 days, 2 years
- 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-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0004
- source section id
- NCT00615589-om-0004
- source outcome index
- 4
- endpoint
- Non Relapse Mortality (NRM) at 1 Year and 3 yearsThe Percentage of Deaths Not Attributable to Disease Relapse or Progression
- endpoint definition
- Non relapse mortality, defined as the percentage of deaths not attributable to disease relapse or progression at 1 year and at 3 years.
- time origin
- 3 years
- 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-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Flu-Bu4
- regimen
- Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00615589-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Flu-Bu4
- regimen
- Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00615589-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Flu-Bu4
- regimen
- Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00615589-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Flu-Bu4
- regimen
- Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00615589-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT00615589
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Flu-Bu4
- regimen
- Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor. Fludarabine/Busulfan x 4 days: Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days -5, -4, -3, and -2 pre-transplant. Busulfan: 3.2 mg/kg IV daily over 4 hours on days -5, -4, -3, and -2. The Fludarabine shall be administered prior to the Busulfan each day.
- analyzed count
- 22
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00615589-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT00615589
- harm key
- EG000
- source section id
- NCT00615589-ae
- event group key
- EG000
- event group label
- Flu-Bu4
- serious affected
- 13
- serious at risk
- 22
- other affected
- 20
- other at risk
- 22
- frequency threshold
- 5
- 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