TriangleNCT01008462 · STUDY IN CONTEXT
Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myelo
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 surviving without relapsed/progressive disease
Relapse/Progression defined as: Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies. Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy .
Number of patients surviving one year post-autograft
aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999). GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
Number of patients with non-relapse mortalities.
Number of patients with donor engraftment.
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-refractory-0d6d63cc
- nct id
- NCT01008462
- trial label
- Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myelo
- 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-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0000
- source section id
- NCT01008462-om-0000
- source outcome index
- 0
- endpoint
- Event-Free Survival (EFS)
- endpoint definition
- Number of patients surviving without relapsed/progressive disease
- time origin
- 1 Year post-autograft
- 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-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0001
- source section id
- NCT01008462-om-0001
- source outcome index
- 1
- endpoint
- Number of Patients With Relapsed/Progressive Disease
- endpoint definition
- Relapse/Progression defined as: Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies. Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy .
- time origin
- 1 year post-autograft
- 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-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0002
- source section id
- NCT01008462-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Number of patients surviving one year post-autograft
- time origin
- 1 year post-autograft
- 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-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0003
- source section id
- NCT01008462-om-0003
- source outcome index
- 3
- endpoint
- Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
- endpoint definition
- aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999). GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
- time origin
- 1 year post-allograft,
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two patients are not evaluable for Graft-versus-Host-Disease due to disease progression; they failed the study and did not receive the allogeneic transplantation.
- 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-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0004
- source section id
- NCT01008462-om-0004
- source outcome index
- 4
- endpoint
- Non-relapse Mortality (NRM)
- endpoint definition
- Number of patients with non-relapse mortalities.
- time origin
- 200 days and 1 Year post-allograft
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.
- 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-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0005
- source section id
- NCT01008462-om-0005
- source outcome index
- 5
- endpoint
- Number of Patients Who Engrafted
- endpoint definition
- Number of patients with donor engraftment.
- time origin
- Day 84 post-allograft
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.
- 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-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Autologous HCT, Donor HCT)
- regimen
- Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01008462-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Autologous HCT, Donor HCT)
- regimen
- Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01008462-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Autologous HCT, Donor HCT)
- regimen
- Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
- analyzed count
- 16
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01008462-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Autologous HCT, Donor HCT)
- regimen
- Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01008462-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Autologous HCT, Donor HCT)
- regimen
- Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01008462-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT01008462
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Autologous HCT, Donor HCT)
- regimen
- Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01008462-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms-refractory-0d6d63cc
- nct id
- NCT01008462
- harm key
- EG000
- source section id
- NCT01008462-ae
- event group key
- EG000
- event group label
- Treatment (Autologous HCT, Donor HCT)
- serious affected
- 1
- serious at risk
- 16
- other affected
- 5
- other at risk
- 16
- frequency threshold
- 0
- collection period
- AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
- 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