TriangleNCT01658904 · STUDY IN CONTEXT
Carfilzomib and Stem Cell Transplant for Plasma Cell Myeloma
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
Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Evaluate the Immune Reconstitution Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Following Carfilzomib (CFZ) Therapy
Evaluate the Effects of the Addition of Carfilzomib (CFZ) in the Early Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Period on the Response Rate at Day 100 Post-AHCT
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
- NCT01658904
- trial label
- Carfilzomib and Stem Cell Transplant for Plasma Cell Myeloma
- 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
- 4
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0000
- source section id
- NCT01658904-om-0000
- source outcome index
- 0
- endpoint
- Engraftment Failure Transplant Related Mortality
- endpoint definition
- Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.
- time origin
- up to day 100
- 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
- NCT01658904
- outcome key
- om-0001
- source section id
- NCT01658904-om-0001
- source outcome index
- 1
- endpoint
- Number of Participants With Adverse Events
- endpoint definition
- Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
- time origin
- 8 months and 15 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Analysis of dose limiting toxicities (DLTs) was planned but not performed due to study termination; this Outcome Measure captures any events that occurred.
- 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
- NCT01658904
- outcome key
- om-0002
- source section id
- NCT01658904-om-0002
- source outcome index
- 2
- endpoint
- Evaluate the Immune Reconstitution Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Following Carfilzomib (CFZ) Therapy
- endpoint definition
- Evaluate the Immune Reconstitution Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Following Carfilzomib (CFZ) Therapy
- time origin
- Post-AHCT following CFZ therapy
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.
- 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
- NCT01658904
- outcome key
- om-0003
- source section id
- NCT01658904-om-0003
- source outcome index
- 3
- endpoint
- Evaluate the Effects of the Addition of Carfilzomib (CFZ) in the Early Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Period on the Response Rate at Day 100 Post-AHCT
- endpoint definition
- Evaluate the Effects of the Addition of Carfilzomib (CFZ) in the Early Post-Pre-autologous Hematopoietic Cell Transplantation (AHCT) Period on the Response Rate at Day 100 Post-AHCT
- time origin
- Day 100 post-AHCT
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- This outcome measure was not done because the study was closed prematurely because the investigator left the National Institutes of Health.
- 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
- NCT01658904
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70. Carfilzomib Melphalan Filgrastim
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70. Carfilzomib Melphalan Filgrastim
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70. Carfilzomib Melphalan Filgrastim
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
- regimen
- Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01658904-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-plasma-cell-neoplasms
- nct id
- NCT01658904
- harm key
- EG000
- source section id
- NCT01658904-ae
- event group key
- EG000
- event group label
- Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
- serious affected
- 0
- serious at risk
- 3
- other affected
- 1
- other at risk
- 3
- 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-plasma-cell-neoplasms
- nct id
- NCT01658904
- harm key
- EG001
- source section id
- NCT01658904-ae
- event group key
- EG001
- event group label
- Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- 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-plasma-cell-neoplasms
- nct id
- NCT01658904
- harm key
- EG002
- source section id
- NCT01658904-ae
- event group key
- EG002
- event group label
- Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- 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