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Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT00461045
Collaborator
(none)
15
Enrollment
6
Locations
1
Arm
91
Duration (Months)
2.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 2, open-label, multicenter study examining the safety, pharmacokinetics and pharmacodynamics, and best overall response to escalating doses of the proteasome inhibitor NPI-0052 (also known as marizomib) in patients with relapsed or relapsed/refractory multiple myeloma. NPI-0052 is a novel, second generation proteasome inhibitor that prevents the breakdown of proteins involved in signal transduction which blocks growth and survival in cancer cells. The study is a Phase 2 study and is a 2-stage efficacy design in a selected subgroup of patients (Arm C) treated with the recommended phase 2 dose of NPI-0052, as determined in a previously completed Phase 1 study. The study is to evaluate the safety and any preliminary evidence of efficacy of NPI-0052 in multiple myeloma patients who have previously received carfilzomib (PR-171, Kyprolis™) and subsequently had disease progression.

Condition or Disease Intervention/Treatment Phase
  • Drug: MRZ 0.5 mg/m^2
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Sep 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: MRZ 0.5 mg/m^2

Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles

Drug: MRZ 0.5 mg/m^2
NPI-0052 0.5 mg/m2 administered IV over 2 hours on Days 1, 4, 8, and 11 in each 21-day cycle
Other Names:
  • Marizomib
  • NPI-0052

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Patients Exhibiting a Given Overall Response as Determined by Investigator [Through study completion, an average of 6.09 weeks.]

      Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.

    Secondary Outcome Measures

    1. Duration of MRZ Treatment [Through study completion, an average of 6.09 weeks.]

      Duration of treatment is defined as the last dose date minus the first dose date of the dose cohort plus 1 expressed in weeks.

    2. Number of Cycles of Marizomib (MRZ) [Through study completion, an average of 6.09 weeks.]

    3. Number of Patients Receiving Marizomib (MRZ) in Each Cycle [Through study completion, an average of 6.09 weeks.]

      A patient was counted in a cycle if the patient received at least one dose of study drug during the cycle.

    4. Number of Patients With Treatment Emergent Adverse Events (TEAEs) [Through study completion, an average of 6.09 weeks.]

      Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug. Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship.

    5. Number of Treatment Emergent Adverse Events (TEAEs) [Through study completion, an average of 6.09 weeks.]

      Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug. Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship.

    6. Maximum Observed Blood Drug Concentration (Cmax) [Samples collected on Cycle 1 Day 1 and Cycle 1 Day 11.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria: Prior to Amendment 13:

    • Age 18 years.

    • Karnofsky Performance Status (KPS) score 70%.

    • All patients must have histologic evidence of multiple myeloma. Evidence of relapsed or relapsed/refractory disease for which no other approved treatment is available and clinically indicated. In addition, patients may have undergone prior bone marrow transplantation. For patients treated at the Recommended Phase 2 Dose patients are required to have measurable relapsed or relapsed/refractory disease. Disease must be assessed within 28 days prior to treatment initiation.

    1. Measurable disease is defined as one of the following:

    • Serum M-protein ≥0.5 g/dL

    • Urine M-protein ≥200 mg/24 hours

    • Involved serum free light chain (FLC) level ≥10 mg/dL, provided the serum FLC ratio is abnormal

    1. Relapsed and Refractory are defined as:

    • Must have received at least 2 prior treatment regimens.

    • Must have received prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of bortezomib (either in separate regimens or within the same regimen).

    • Must have received a cytotoxic chemotherapy agent (eg, alkylating agent).

    • Relapsed Disease: Must have progressive disease after having achieved at least stable disease for at least one cycle of treatment during at least one prior regimen.

    • Refractory Disease: Must have documented evidence of progressive disease during or within 60 days (measured from the end of the last cycle) of completing the most recently received anti-myeloma drug regimen prior to study entry

    • All AEs resulting from prior chemotherapy, surgery, or radiotherapy must have resolved to NCI-CTCAE Grade 1 (except for hematologic parameters outlined below).

    • The following laboratory results, within 7 days prior to NPI-0052 administration (transfusions and/or growth factor support may be used with discretion by the

    Investigator during Screening):

    • Hemoglobin 8 g/dL

    • Absolute neutrophil count 0.5 × 109/L

    • Platelet count 30 × 109/L

    • Serum bilirubin 1.5 × ULN

    • AST 2.5 × ULN

    • Serum creatinine 1.5 × ULN

    • Creatinine clearance ≥40 mL/min

    • Signed informed consent.

    • Must have previously received at least 2 cycles of carfilzomib (as a single agent or in combination with other agents) and subsequently had disease progression during or within 60 days of carfilzomib therapy. Carfilzomib does not have to be the most recent therapy that the patient has received, but patients must have documented disease progression during or within 60 days of their last anti-myeloma therapy

    Inclusion Criteria Amendment 13:

    • Age 18 years.

    • Karnofsky Performance Status score 70%.

    • All patients must have histologic evidence of multiple myeloma and evidence of relapsed or relapsed/refractory disease as defined below Patients are required to have measurable relapsed or relapsed/refractory disease. Disease must be assessed within 28 days prior to treatment initiation.

    1. Measurable disease defined as one of the following:

    • Serum M-protein ≥0.5 g/dL

    • Urine M-protein ≥200 mg/24 hours

    • Involved serum free light chain (FLC) level ≥10 mg/dL provided the serum FLC ratio is abnormal

    1. Relapsed and Refractory are defined as:

    • Must have received at least 2 prior treatment regimens.

    • Must have received prior treatment with at least 2 cycles of an immunomodulator (lenalidomide or pomalidomide or thalidomide).

    • Must have previously received at least 2 cycles of carfilzomib (as a single agent or in combination with other agents) and subsequently had disease progression during or within 60 days of carfilzomib therapy. Carfilzomib does not have to be the most recent therapy that the patient has received, but patients must have documented disease progression during or within 60 days of their last anti-myeloma therapy. Patients may also have received bortezomib.

    In addition, patients may have undergone prior cytotoxic chemotherapy, bone marrow transplantation and previously participated in other clinical trials.

    • Relapsed Disease: Must have progressive disease after having achieved at least stable disease for at least one cycle of treatment during at least one prior regimen.

    • Refractory Disease: Must have documented evidence of progressive disease during or within 60 days (measured from the end of the last cycle) of completing the most recently received anti-myeloma drug regimen prior to study entry.

    • All Adverse Events resulting from prior chemotherapy, surgery, or radiotherapy, must have resolved to CTCAE Grade 1 (except for hematologic parameters outlined below).

    • The following laboratory results, within 7 days of NPI-0052 administration (transfusions and/or growth factor support may be used with discretion by the

    Investigator during the screening period):

    • Hemoglobin 8 g/dL

    • Absolute neutrophil count 0.5 x 109/L

    • Platelet count 30 x 109/L

    • Serum bilirubin 1.5 x ULN

    • AST 2.5 x ULN

    • Serum creatinine 1.5 x ULN

    • Creatinine clearance ≥40 mL/min -Signed informed consent.

    Exclusion Criteria:

    • Administration of chemotherapy, biological, immunotherapy, or investigational agent (therapeutic or diagnostic) within 14 days prior to receipt of study medication (this washout period can be reduced to 7 days for biologically targeted therapies (eg, bortezomib, carfilzomib, thalidomide, lenalidomide, pomalidomide, and dexamethasone or equivalent), provided the patient has recovered from the toxicity from these regimens per Inclusion Criterion #4). Patients must be 6 weeks from last dose of nitrosourea and 12 weeks from BMT. Patients must be 2 weeks from last dose of radiation.

    • Patients with Grade >1 proteinuria (1 g/24 hour excluding M proteins = urine paraprotein subtracted from total urine protein), untreated urinary tract infection, as well as any pre existing kidney disease (acute or chronic) that in the Investigator's assessment would impose excessive risk to the patient.

    • Patients with evidence of mucosal or internal bleeding and/or platelet refractory (ie, unable to maintain platelet count 30 × 109/L).

    • Significant cardiac disease defined as:

    • Patients with congenital long QT syndrome;

    • Congestive heart failure of Class III or IV of the NYHA classification;

    • History of myocardial infarction or ischemia within 12 months of study enrollment.

    • Abnormal left ventricular ejection fraction (LVEF) (< lower limit of normal as defined by the study site for a patient of that age) by echocardiogram (ECHO) or multiple-gated angiography (MUGA).

    • Patients with a prior hypersensitivity reaction of CTCAE Grade >3 to therapy containing propylene glycol or ethanol.

    • Pregnant or breast-feeding women. Female patients must be postmenopausal or surgically sterile, or they must agree to use acceptable methods of birth control (ie, a hormonal contraceptive with barrier method, intra-uterine device, diaphragm with spermicidal or condom with spermicide, or abstinence) for the duration of the study and for one month following study completion. Female patients with childbearing potential must have a negative serum pregnancy test within the 7 days before the first NPI-0052 administration. Male patients must be surgically sterile or agree to use an acceptable method of contraception.

    • Active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.

    • Known to be HIV positive or positive and active for hepatitis A, B, or C.

    • Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include infection requiring parenteral or oral anti-infective treatment or any altered mental status or psychiatric condition that would interfere with an understanding of the informed consent.

    • Unwilling or unable to comply with procedures required in this protocol.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moffitt Cancer Center Tampa Florida United States 33612
    2 University of Chicago, School of Medicine Chicago Illinois United States 60637
    3 University of Maryland Baltimore Maryland United States 21201
    4 Dana Farber Cancer Institute Boston Massachusetts United States 02115
    5 University of Michigan Ann Arbor Michigan United States 48109
    6 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Steven D Reich, MD, Triphase Research and Development I Corp

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT00461045
    Other Study ID Numbers:
    • NPI-0052-101
    First Posted:
    Apr 17, 2007
    Last Update Posted:
    Dec 19, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Celgene
    multiple myeloma
    proteasome inhibitor
    relapsed
    refractory
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    Period Title: Overall Study
    STARTED 15
    COMPLETED 15
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    Overall Participants 15
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    61.9
    (8.02)
    Sex: Female, Male (Count of Participants)
    Female
    5
    33.3%
    Male
    10
    66.7%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    Not Hispanic or Latino
    15
    100%
    Unknown or Not Reported
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    2
    13.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    3
    20%
    White
    10
    66.7%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    15
    100%
    Baseline Height (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    170.97
    (12.152)
    Baseline Weight (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    77.27
    (17.825)
    Body Surface Area (BSA) (m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [m^2]
    1.893
    (0.2629)
    Fertility Status (Count of Participants)
    Potential able to bear children
    0
    0%
    Surgically sterile
    1
    6.7%
    Post menopausal
    4
    26.7%
    Male
    10
    66.7%
    Karnofsky Performance Status (KPS) Score (KPS Score) [Mean (Full Range) ]
    Mean (Full Range) [KPS Score]
    87.3
    Time Since Initial Diagnosis (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    5.2
    (3.79)
    Number of Relapses (participants) [Number]
    1 Relapse
    0
    0%
    2 Relapses
    2
    13.3%
    3 Relapses
    2
    13.3%
    >3 Relapses
    11
    73.3%

    Outcome Measures

    1. Primary Outcome
    Title Number of Patients Exhibiting a Given Overall Response as Determined by Investigator
    Description Disease response and progression were determined by the investigator using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC). Overall response rate includes patients with a best response of PR of better. Stringent complete response (CR) includes immunophenotypic CR and molecular CR in addition to stringent CR.
    Time Frame Through study completion, an average of 6.09 weeks.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    Measure Participants 15
    Stringent Complete Response (sCR) or better
    0
    0%
    Complete Response (CR)
    0
    0%
    Very Good Partial Response (VGPR)
    0
    0%
    Partial Response (PR)
    0
    0%
    Minimal Response (MR)
    0
    0%
    Stable Disease (SD)
    4
    26.7%
    Progressive Disease (PD)
    9
    60%
    Not Evaluated
    2
    13.3%
    2. Secondary Outcome
    Title Duration of MRZ Treatment
    Description Duration of treatment is defined as the last dose date minus the first dose date of the dose cohort plus 1 expressed in weeks.
    Time Frame Through study completion, an average of 6.09 weeks.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    Measure Participants 15
    Mean (Standard Deviation) [weeks]
    6.09
    (4.661)
    3. Secondary Outcome
    Title Number of Cycles of Marizomib (MRZ)
    Description
    Time Frame Through study completion, an average of 6.09 weeks.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    Measure Participants 15
    Mean (Standard Deviation) [cycles]
    2.6
    (1.45)
    4. Secondary Outcome
    Title Number of Patients Receiving Marizomib (MRZ) in Each Cycle
    Description A patient was counted in a cycle if the patient received at least one dose of study drug during the cycle.
    Time Frame Through study completion, an average of 6.09 weeks.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    Measure Participants 15
    Cycle 1
    15
    100%
    Cycle 2
    12
    80%
    Cycle 3
    6
    40%
    Cycle 4
    3
    20%
    Cycle 5
    2
    13.3%
    Cycle 6
    1
    6.7%
    5. Secondary Outcome
    Title Number of Patients With Treatment Emergent Adverse Events (TEAEs)
    Description Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug. Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship.
    Time Frame Through study completion, an average of 6.09 weeks.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    Measure Participants 15
    At least one TEAE
    15
    100%
    At least one treatment related TEAE
    14
    93.3%
    At least one NPI-0052 related TEAE
    13
    86.7%
    At least one grade ≥3 TEAE
    12
    80%
    At least one treatment related grade ≥3 TEAE
    8
    53.3%
    At least one NPI-0052 related grade ≥3 TEAE
    5
    33.3%
    At least one serious TEAE
    7
    46.7%
    At least one treatment related serious TEAE
    4
    26.7%
    At least one NPI-0052 related serious TEAE
    1
    6.7%
    6. Secondary Outcome
    Title Number of Treatment Emergent Adverse Events (TEAEs)
    Description Adverse events were graded using NCI-CTCAE (version 4.3). TEAEs are defined as any adverse event with an onset date between the date of first dose and 30 days after the date of last dose of any study drug. Treatment-related adverse events are adverse events considered related to at least one study drug by the investigator (NPI-002, dexamethasone), including those with unknown relationship.
    Time Frame Through study completion, an average of 6.09 weeks.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    Measure Participants 15
    Number of TEAEs
    149
    Number of treatment related TEAEs
    73
    Number of NPI-0052 related TEAEs
    50
    Number of grade ≥3 TEAEs
    41
    Number of treatment related grade ≥3 TEAEs
    16
    Number of NPI-0052 realted grade ≥3 TEAEs
    9
    Number of serious TEAEs
    21
    Number of treatment related serious TEAEs
    5
    Number of NPI-0052 related serious TEAEs
    1
    7. Secondary Outcome
    Title Maximum Observed Blood Drug Concentration (Cmax)
    Description
    Time Frame Samples collected on Cycle 1 Day 1 and Cycle 1 Day 11.

    Outcome Measure Data

    Analysis Population Description
    The sponsor elected not to analyze the pharmacokinetic (PK) samples collected, therefore, no PK results are obtained.
    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    Measure Participants 0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title MRZ 0.5 mg/m^2
    Arm/Group Description Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles
    All Cause Mortality
    MRZ 0.5 mg/m^2
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    MRZ 0.5 mg/m^2
    Affected / at Risk (%) # Events
    Total 7/15 (46.7%)
    Cardiac disorders
    Cardiac Failure Congestive 2/15 (13.3%)
    Atrial Fibrillation 1/15 (6.7%)
    Cardiac Failure 1/15 (6.7%)
    General disorders
    Adverse Drug Reaction 1/15 (6.7%)
    Hepatobiliary disorders
    Ischaemic Hepatitis 1/15 (6.7%)
    Infections and infestations
    Sepsis 1/15 (6.7%)
    Pneumonia 1/15 (6.7%)
    Arthritis Bacterial 1/15 (6.7%)
    Bacteraemia 1/15 (6.7%)
    Diverticulitis 1/15 (6.7%)
    Endocarditis Bacterial 1/15 (6.7%)
    Escherichia Bacteraemia 1/15 (6.7%)
    Injury, poisoning and procedural complications
    Femur Fracture 1/15 (6.7%)
    Humerus Fracture 1/15 (6.7%)
    Metabolism and nutrition disorders
    Hyperglycaemia 1/15 (6.7%)
    Musculoskeletal and connective tissue disorders
    Pathological Fracture 1/15 (6.7%)
    Nervous system disorders
    Embolic Stroke 1/15 (6.7%)
    Renal and urinary disorders
    Renal failure acute 2/15 (13.3%)
    Vascular disorders
    Hypotension 1/15 (6.7%)
    Other (Not Including Serious) Adverse Events
    MRZ 0.5 mg/m^2
    Affected / at Risk (%) # Events
    Total 15/15 (100%)
    Blood and lymphatic system disorders
    Anaemia 4/15 (26.7%)
    Thrombocytopenia 4/15 (26.7%)
    Neutropenia 1/15 (6.7%)
    Pancytopenia 1/15 (6.7%)
    Cardiac disorders
    Cardiac Failure Congestive 2/15 (13.3%)
    Atrial Fibrillation 1/15 (6.7%)
    Cardiac Failure 1/15 (6.7%)
    Sinus Tachycardia 1/15 (6.7%)
    Tachycardia 1/15 (6.7%)
    Gastrointestinal disorders
    Vomiting 2/15 (13.3%)
    Constipation 3/15 (20%)
    Nausea 4/15 (26.7%)
    Diarrhoea 2/15 (13.3%)
    Abdominal Pain 1/15 (6.7%)
    Abdominal Tenderness 1/15 (6.7%)
    Dyspepsia 1/15 (6.7%)
    Ileus 1/15 (6.7%)
    Pneumoperitoneum 1/15 (6.7%)
    General disorders
    Fatigue 9/15 (60%)
    Oedema peripheral 1/15 (6.7%)
    Pyrexia 1/15 (6.7%)
    Asthenia 1/15 (6.7%)
    Chills 1/15 (6.7%)
    Gait disturbance 2/15 (13.3%)
    Adverse Drug Reaction 1/15 (6.7%)
    Infusion Site Erythema 1/15 (6.7%)
    Vessel Puncture Site Pain 1/15 (6.7%)
    Hepatobiliary disorders
    Ischaemic Hepatitis 1/15 (6.7%)
    Infections and infestations
    Upper respiratory tract infection 2/15 (13.3%)
    Urinary tract infection 1/15 (6.7%)
    Pneumonia 3/15 (20%)
    Bacteraemia 2/15 (13.3%)
    Arthritis Bacterial 1/15 (6.7%)
    Diverticulitis 1/15 (6.7%)
    Endocarditis Bacterial 1/15 (6.7%)
    Escherichia Bacteraemia 1/15 (6.7%)
    Nasopharyngitis 1/15 (6.7%)
    Oral Candidiasis 1/15 (6.7%)
    Respiratory Tract Infection 1/15 (6.7%)
    Sepsis 1/15 (6.7%)
    Injury, poisoning and procedural complications
    Contusion 1/15 (6.7%)
    Femur Fracture 1/15 (6.7%)
    Humerus Fracture 1/15 (6.7%)
    Investigations
    Blood Creatinine Increased 2/15 (13.3%)
    Weight Decreased 2/15 (13.3%)
    International Normalised Ratio Increased 1/15 (6.7%)
    Neutrophil Count Decreased 1/15 (6.7%)
    Platelet Count Decreased 1/15 (6.7%)
    Metabolism and nutrition disorders
    Hyperglycaemia 2/15 (13.3%)
    Hypokalaemia 2/15 (13.3%)
    Decreased Appetite 1/15 (6.7%)
    Hyperuricaemia 1/15 (6.7%)
    Hypomagnesaemia 1/15 (6.7%)
    Hyponatraemia 1/15 (6.7%)
    Metabolic Acidosis 1/15 (6.7%)
    Metabolic Alkalosis 1/15 (6.7%)
    Musculoskeletal and connective tissue disorders
    Pain in extremity 2/15 (13.3%)
    Back pain 2/15 (13.3%)
    Arthralgia 2/15 (13.3%)
    Muscle spasms 1/15 (6.7%)
    Pain in Jaw 2/15 (13.3%)
    Pathological Fracture 2/15 (13.3%)
    Musculoskeletal Pain 1/15 (6.7%)
    Neck Pain 1/15 (6.7%)
    Nervous system disorders
    Dysgeusia 2/15 (13.3%)
    Aphasia 1/15 (6.7%)
    Dysarthria 1/15 (6.7%)
    Embolic Stroke 1/15 (6.7%)
    Head Discomfort 1/15 (6.7%)
    Memory Impairment 1/15 (6.7%)
    Psychiatric disorders
    Hallucination, Visual 1/15 (6.7%)
    Mental status changes 1/15 (6.7%)
    Anxiety 3/15 (20%)
    Insomnia 5/15 (33.3%)
    Confusional State 2/15 (13.3%)
    Dysphoria 1/15 (6.7%)
    Pressure of Speech 1/15 (6.7%)
    Renal and urinary disorders
    Renal Failure Acute 2/15 (13.3%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 3/15 (20%)
    Asthma 1/15 (6.7%)
    Cough 1/15 (6.7%)
    Epistaxis 1/15 (6.7%)
    Pneumonia Aspiration 1/15 (6.7%)
    Productive Cough 1/15 (6.7%)
    Rhinorrhoea 1/15 (6.7%)
    Sinus Congestion 1/15 (6.7%)
    Skin and subcutaneous tissue disorders
    Rash 1/15 (6.7%)
    Rash Pruritic 1/15 (6.7%)
    Skin Mass 1/15 (6.7%)
    Vascular disorders
    Hypotension 1/15 (6.7%)
    Phlebitis 1/15 (6.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Associate Director of Clinical and Regulatory Operations
    Organization Triphase Accelerator
    Phone 858-295-4337
    Email jennifer.ki@triphaseco.com
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT00461045
    Other Study ID Numbers:
    • NPI-0052-101
    First Posted:
    Apr 17, 2007
    Last Update Posted:
    Dec 19, 2017
    Last Verified:
    Nov 1, 2017