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← Hodgkin Lymphoma

NCT00150462 · STUDY IN CONTEXT

Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies

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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

A DLT was defined as any of the following occurring in the first 28 days of study participation: Nonhematologic: * \> Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support * Febrile neutropenia (ANC \< 1.0 × 10ˆ9/L with a fever ≥ 38.3°C) * Grade 4 thrombocytopenia (platelets \< 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.

Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib

→

primary · POSTED

Maximum Observed Plasma Concentration of Carfilzomib (Cmax)

Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

→

secondary · POSTED

Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows: * Complete response: total resolution of measurable disease parameters. * Partial response: a ≥ 50% resolution without the appearance of new disease. * Stable disease: between \< 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease. * Progressive disease: an increase of \> 25% in measurable disease parameters. Best clinical response is the best response observed from the start of study treatment until disease progression or death.

Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.

→

secondary · POSTED

Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median duration of response was calculated using the Kaplan-Meier method.

Biologic response-evaluable participants with an objective response

→

secondary · POSTED

Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment. Median time to progression was calculated using the Kaplan-Meier method.

Biologic response-evaluable population

→

secondary · POSTED

Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.

Biologic response-evaluable population

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Number of Participants With Dose-limiting Toxicities (DLTs)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma
nct id
NCT00150462
qol key
qol-0000
source section id
NCT00150462-om-0000
source outcome index
0
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Number of Participants With Dose-limiting Toxicities (DLTs)
measure definition
A DLT was defined as any of the following occurring in the first 28 days of study participation: Nonhematologic: * \> Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support * Febrile neutropenia (ANC \< 1.0 × 10ˆ9/L with a fever ≥ 38.3°C) * Grade 4 thrombocytopenia (platelets \< 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
time frame
28 days
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma
nct id
NCT00150462
trial label
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies
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
6
harms Count
11
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    source section id
    NCT00150462-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Dose-limiting Toxicities (DLTs)
    endpoint definition
    A DLT was defined as any of the following occurring in the first 28 days of study participation: Nonhematologic: * \> Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support * Febrile neutropenia (ANC \< 1.0 × 10ˆ9/L with a fever ≥ 38.3°C) * Grade 4 thrombocytopenia (platelets \< 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
    time origin
    28 days
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0001
    source section id
    NCT00150462-om-0001
    source outcome index
    1
    endpoint
    Maximum Observed Plasma Concentration of Carfilzomib (Cmax)
    endpoint definition
    Maximum Observed Plasma Concentration of Carfilzomib (Cmax)
    time origin
    Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0002
    source section id
    NCT00150462-om-0002
    source outcome index
    2
    endpoint
    Best Clinical Response to Treatment
    endpoint definition
    Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows: * Complete response: total resolution of measurable disease parameters. * Partial response: a ≥ 50% resolution without the appearance of new disease. * Stable disease: between \< 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease. * Progressive disease: an increase of \> 25% in measurable disease parameters. Best clinical response is the best response observed from the start of study treatment until disease progression or death.
    time origin
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0003
    source section id
    NCT00150462-om-0003
    source outcome index
    3
    endpoint
    Duration of Response
    endpoint definition
    Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median duration of response was calculated using the Kaplan-Meier method.
    time origin
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Biologic response-evaluable participants with an objective response
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0004
    source section id
    NCT00150462-om-0004
    source outcome index
    4
    endpoint
    Time to Progression
    endpoint definition
    Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment. Median time to progression was calculated using the Kaplan-Meier method.
    time origin
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Biologic response-evaluable population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0005
    source section id
    NCT00150462-om-0005
    source outcome index
    5
    endpoint
    Progression-free Survival
    endpoint definition
    Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.
    time origin
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Biologic response-evaluable population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG000
    arm label
    CFZ 1.2 mg/m²
    regimen
    Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG001
    arm label
    CFZ 2.4 mg/m²
    regimen
    Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG002
    arm label
    CFZ 4.0 mg/m²
    regimen
    Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG003
    arm label
    CFZ 6.0 mg/m²
    regimen
    Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG004
    arm label
    CFZ 8.4 mg/m²
    regimen
    Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG004
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG005
    arm label
    CFZ 11.0 mg/m²
    regimen
    Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG005
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG006
    arm label
    CFZ 15.0 mg/m²
    regimen
    Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG006
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG007
    arm label
    CFZ 20.0 mg/m²
    regimen
    Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG007
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG008
    arm label
    CFZ 27.0 mg/m²
    regimen
    Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG008
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG009
    arm label
    CFZ 20/27 mg/m²
    regimen
    Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
    analyzed count
    7
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG009
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0000
    arm key
    OG010
    arm label
    CFZ 20/27 mg/m² + DEX
    regimen
    Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0000#groups/OG010
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    outcome key
    om-0001
    arm key
    OG000
    arm label
    CFZ 1.2 mg/m²
    regimen
    Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00150462-om-0001#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG000
    source section id
    NCT00150462-ae
    event group key
    EG000
    event group label
    CFZ 1.2 mg/m²
    serious affected
    2
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG001
    source section id
    NCT00150462-ae
    event group key
    EG001
    event group label
    CFZ 2.4 mg/m²
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG002
    source section id
    NCT00150462-ae
    event group key
    EG002
    event group label
    CFZ 4.0 mg/m²
    serious affected
    3
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG003
    source section id
    NCT00150462-ae
    event group key
    EG003
    event group label
    CFZ 6.0 mg/m²
    serious affected
    2
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG004
    source section id
    NCT00150462-ae
    event group key
    EG004
    event group label
    CFZ 8.4 mg/m²
    serious affected
    2
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG005
    source section id
    NCT00150462-ae
    event group key
    EG005
    event group label
    CFZ 11.0 mg/m²
    serious affected
    2
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG006
    source section id
    NCT00150462-ae
    event group key
    EG006
    event group label
    CFZ 15.0 mg/m²
    serious affected
    1
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG007
    source section id
    NCT00150462-ae
    event group key
    EG007
    event group label
    CFZ 20.0 mg/m²
    serious affected
    3
    serious at risk
    8
    other affected
    8
    other at risk
    8
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG008
    source section id
    NCT00150462-ae
    event group key
    EG008
    event group label
    CFZ 27.0 mg/m²
    serious affected
    4
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG009
    source section id
    NCT00150462-ae
    event group key
    EG009
    event group label
    CFZ 20/27 mg/m²
    serious affected
    3
    serious at risk
    7
    other affected
    7
    other at risk
    7
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    harm key
    EG010
    source section id
    NCT00150462-ae
    event group key
    EG010
    event group label
    CFZ 20/27 mg/m² + DEX
    serious affected
    2
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    5
    collection period
    From the first dose of study drug until 30 days after the last dose. Median duration of treatment was 6.3 weeks in the dose escalation phase and 6.4 weeks in the dose expansion phase.
    event definition
    Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma
    nct id
    NCT00150462
    qol key
    qol-0000
    source section id
    NCT00150462-om-0000
    source outcome index
    0
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Number of Participants With Dose-limiting Toxicities (DLTs)
    measure definition
    A DLT was defined as any of the following occurring in the first 28 days of study participation: Nonhematologic: * \> Grade 2 neuropathy with pain * ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea) * ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: * Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support * Febrile neutropenia (ANC \< 1.0 × 10ˆ9/L with a fever ≥ 38.3°C) * Grade 4 thrombocytopenia (platelets \< 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding. Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.
    time frame
    28 days
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice