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NCT00150462 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1
Status at capture
COMPLETED
Registry last update
2017-05-02

The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Dose-limiting Toxicities (DLTs)

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outcome · POSTED

Maximum Observed Plasma Concentration of Carfilzomib (Cmax)

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outcome · POSTED

Best Clinical Response to Treatment

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outcome · POSTED

Duration of Response

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outcome · POSTED

Time to Progression

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)

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outcome · POSTED

Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib

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outcome · POSTED

Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. Written informed consent in accordance with federal, local, and institutional guidelines 2. Males and females ≥18 years of age 3. Histologically confirmed diagnosis of one of the hematologic malignancies below: * Multiple myeloma (MM) * Non-Hodgkin's lymphoma (NHL) * Waldenström's Macroglobulinemia (WM) * Hodgkin's disease (HD) 4. Subjects who are refractory or relapsed following at least two prior therapies 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 6. Adequate cardiovascular function without symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction in the previous six months 7. Adequate hepatic function, with bilirubin \< 2.0 times the upper limit of normal, and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) of \< 3.0 times the upper limit of normal 8. Total white blood cell (WBC) count ≥ 2,000/mm³, absolute neutrophil count (ANC) ≥ 1000/mm³, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 50,000/mm³ * Screening ANC should be independent of granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support for ≥ 1 week and of pegylated G-CSF for ≥ 2 weeks) * Subjects receiving supportive care including erythropoietin, darbepoetin and/or bisphosphonates can continue to do so, but must be transfusion independent; subjects receiving erythropoietic support must remain on the same dose for the first 28 days of study participation 9. An estimated creatinine clearance of ≥ 30 mL/min, calculated using the formula of Cockroft and Gault 10. Serum creatinine ≤ 2.0 mg/dL 11. Uric acid, if elevated, must be corrected to within laboratory normal range prior to dosing 12. Female subjects of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test. Male subjects must use an effective barrier method of contraception throughout the study and for three months following the last dose if sexually active with a female of child-bearing potential. Exclusion Criteria: 1. Female subjects who are pregnant or lactating 2. Subjects who are transfusion dependent 3. Subjects with NHL or HL who have received steroid therapy in the previous seven days 4. Subjects with MM or Waldenström's Macroglobulinemia who have received steroid therapy in the previous three weeks, except for MM subjects in the Carfilzomib + DEX Expansion Cohort, where previous treatment with dexamethasone will be allowed. The dose and schedule of administration of dexamethasone will be adjusted to that used in the protocol 5. Radiation, chemotherapy, or immunotherapy in the previous four weeks, or subjects who, in the judgment of the Investigator, have not recovered from the effects of previous therapy 6. For the Dose Escalation period, subjects who have received prior radioimmunotherapy with anti-cluster of differentiation (CD)20 monoclonal antibodies such as Bexxar® or Zevalin®; subjects treated with these products will be allowed in the Dose Expansion period 7. Subjects who have received allogeneic stem cell transplant therapy 8. Subjects with NHL or HL who have received autologous stem cell transplant therapy and have relapsed within 100 days of therapy 9. Rituxan therapy within three months before Day 1 unless there is evidence of disease progression 10. Major surgery within three weeks before Day 1 11. Congestive heart failure (CHF) (New York Heart Association class III to IV) 12. Acute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose 13. Subjects who are known or suspected of having human immunodeficiency virus (HIV) infection or who are HIV seropositive 14. Active hepatitis A, B, or C infection; or positive for Hepatitis C ribonucleic acid (RNA) or hepatitis B antigen 15. Non-hematologic malignancy within the past three years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer with stable prostate specific antigen (PSA) levels for three years 16. Subjects with treatment-related myelodysplastic disorder 17. Subjects with known brain metastasis (active central nervous system \[CNS\] disease only) 18. Serious psychiatric or medical conditions that could interfere with treatment 19. Participation in an investigational therapeutic study within one month prior to Day 1 20. Significant neurotoxicity (Grade 2 or higher with pain) at the time of study initiation 21. Concurrent therapy with approved or investigative anticancer therapeutics 22. Subjects with previous hypersensitivity to bortezomib injection 23. Subjects with contraindications to receiving allopurinol 24. Subjects in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac, or renal impairment 25. Subjects with known or suspected amyloidosis 26. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 1.2 mg/m²
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 2.4 mg/m²
    type
    EXPERIMENTAL
  3. description
    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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 4.0 mg/m²
    type
    EXPERIMENTAL
  4. description
    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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 6.0 mg/m²
    type
    EXPERIMENTAL
  5. description
    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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 8.4 mg/m²
    type
    EXPERIMENTAL
  6. description
    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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 11.0 mg/m²
    type
    EXPERIMENTAL
  7. description
    Participants received carfilzomib 115.0 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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 15.0 mg/m²
    type
    EXPERIMENTAL
  8. description
    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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 20.0 mg/m²
    type
    EXPERIMENTAL
  9. description
    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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 27.0 mg/m²
    type
    EXPERIMENTAL
  10. description
    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.
    intervention Names
    1. Drug: Carfilzomib
    label
    CFZ 20/27 mg/m²
    type
    EXPERIMENTAL
  11. description
    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).
    intervention Names
    1. Drug: Carfilzomib
    2. Drug: Dexamethasone
    label
    CFZ 20/27 mg/m² + DEX
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. CFZ 1.2 mg/m²
    2. CFZ 11.0 mg/m²
    3. CFZ 15.0 mg/m²
    4. CFZ 2.4 mg/m²
    5. CFZ 20.0 mg/m²
    6. CFZ 20/27 mg/m²
    7. CFZ 20/27 mg/m² + DEX
    8. CFZ 27.0 mg/m²
    9. CFZ 4.0 mg/m²
    10. CFZ 6.0 mg/m²
    11. CFZ 8.4 mg/m²
    description
    Administered as an IV bolus dose
    name
    Carfilzomib
    other Names
    1. PR-171
    2. Kyprolis
    type
    DRUG
  2. arm Group Labels
    1. CFZ 20/27 mg/m² + DEX
    description
    Administered orally prior to carfilzomib
    name
    Dexamethasone
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
48
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Number of Participants With Dose-limiting Toxicities (DLTs)
    time Frame
    28 days
  2. measure
    Maximum Observed Plasma Concentration of Carfilzomib (Cmax)
    time Frame
    Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
  3. measure
    Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)
    time Frame
    Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
  4. measure
    Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib
    time Frame
    Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
  5. measure
    Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib
    time Frame
    Cycle 1, Day 1 at predose, 5, 15, and 30 minutes, and 1, 2, 4, and 24 hours post dose.
secondary Outcomes
  1. description
    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.
    measure
    Best Clinical Response to Treatment
    time Frame
    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.
  2. description
    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.
    measure
    Duration of Response
    time Frame
    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.
  3. description
    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.
    measure
    Time to Progression
    time Frame
    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.
  4. description
    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.
    measure
    Progression-free Survival
    time Frame
    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.
Full study description
brief Summary
The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.
Source references
Source notices and limitations
    Discovery and provenance
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice