Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT01281917
Collaborator
Millennium Pharmaceuticals, Inc. (Industry), Pfizer (Industry), National Cancer Institute (NCI) (NIH)
40
18
1
40
2.2
0.1

Study Details

Study Description

Brief Summary

The investigators want to find out if the drugs Velcade and temsirolimus given together are effective in treating cancer. Velcade and temsirolimus are each FDA approved individually for certain types of cancer (Velcade for multiple myeloma and mantle cell lymphoma, and temsirolimus for renal cell carcinoma) but are not currently approved in combination for B-cell non-Hodgkin lymphoma. The investigators are trying to find out if giving these 2 drugs together will improve the period of time that the patient's cancer is stopped or slowed from growing and causing symptoms.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Velcade and Temsirolimus for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Velcade plus Temsirolimus

Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long.

Drug: Velcade
Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
Other Names:
  • bortezomib, PS-341
  • Drug: Temsirolimus
    Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Other Names:
  • Torisel
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate [Up to 60 months]

      The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    2. Progression Free Survival [Up to 60 months]

      The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).

    Secondary Outcome Measures

    1. Safety of This Regimen [Up to 36 months]

      Safety of the regimen will be measured by frequency and severity of adverse events.

    2. Complete Response Rate [Up to 60 months]

      The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.

    3. Tolerability of the Regimen [Up to 36 months]

      Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.

    4. Duration of Response [Up to 60 months]

      Duration of Response is how long a response to therapy is held before a subject has progressive disease.

    5. Overall Survival [Up to 60 months]

      Length of time from enrollment until death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Relapsed or refractory B-cell non-Hodgkin lymphoma which includes: diffuse large B-cell lymphoma; primary mediastinal large B-cell lymphoma; follicular lymphoma (grade 1, 2 or 3); mantle cell lymphoma; small lymphocytic lymphoma; marginal zone lymphoma; lymphoplasmacytic lymphoma; B-cell lymphoblastic lymphoma; or Burkitt lymphoma. "Grey-zone" lymphomas must be approved by the Wisconsin Oncology Network (WON) Study Chair or Principal Investigator prior to enrollment.

    • At least one measurable tumor mass (>1.5 cm in the long axis and > 1.0 cm in the short axis) that has not been previously irradiated, or has grown since previous irradiation.

    • Documented relapse or progression following prior antineoplastic therapy.

    • No clinical or documented radiographic evidence of central nervous system lymphoma.

    • Eastern Cooperative Oncology Group [ECOG] performance status of 0-2.

    • The following clinical laboratory values within 14 days prior to enrollment:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells / L

    • Platelets ≥ 100 x 109 cells / L

    • Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 3X the upper limit of normal (ULN)

    • Total bilirubin ≤ 2X the upper limit of normal (ULN).

    • Calculated creatinine clearance ≥40 mL/min (using the Cockcroft-Gault equation).

    • Female subjects must be either post-menopausal for at least 1 year or surgically sterilized, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of Velcade, or agree to completely abstain from heterosexual intercourse.

    • Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.

    Exclusions:
    • Antineoplastic, experimental, or radiation therapy within 14 days prior to enrollment, or 21 days prior to Day 1 of Cycle 1.

    • Radioimmunoconjugates within 10 weeks of Day 1 of Cycle 1.

    • Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or any prior history of allogeneic stem cell transplant.

    • Platelet transfusion within 7 days of Day 1 of Cycle 1.

    • Ongoing therapy with glucocorticoids. Prednisone ≤15 mg per day or its equivalent is allowed.

    • Patient has Grade 2 or greater peripheral neuropathy within 14 days before enrollment.

    • Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

    • Patient has hypersensitivity to Velcade, boron or mannitol.

    • Female subjects that are pregnant or breast-feeding.

    • Serious medical or psychiatric illness that is likely to interfere with participation

    • Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

    • Prior therapy with both Velcade and temsirolimus. Patients who have previously been treated with either Velcade or temsirolimus (but not both) are eligible.

    • Radiation therapy within 3 weeks before randomization.

    • Patients must not be taking the following strong CyP3A inducers at study entry: phenytoin, phenobarbital, rifampin, carbamazepin, rifabutin, rifampicin, a one week washout period is required.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rapid City Regional Hospital John T. Vucurevich Cancer Care Institute Rapid City South Dakota United States 57701
    2 Aurora Baycare Medical Center-GreenBay Green Bay Wisconsin United States 54143
    3 St Vincent Regional Cancer Center CCOP Green Bay Wisconsin United States 54301
    4 Bellin Memorial Hospital, Inc Green Bay Wisconsin United States 54313
    5 Gunderson Lutheran Health System La Crosse Wisconsin United States 54601
    6 UW Health Oncology- 1 S Park Madison Wisconsin United States 53715
    7 University Of Wisconsin Cancer Center Madison Wisconsin United States 53792
    8 Aurora BayCare Medical Center Marinette Wisconsin United States
    9 Marshfield Clinic Marshfield Wisconsin United States 54449
    10 Columbia St Mary's, Inc Milwaukee Wisconsin United States 53211
    11 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    12 Aurora Sheboygan Memorial Medical Center Sheboygan Wisconsin United States 53081
    13 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    14 Aurora Medical Center in Two Rivers Two Rivers Wisconsin United States 54241
    15 Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    16 Aspirus Wausau Hospital Wausau Wisconsin United States 54401
    17 Aurora Health Care Metro, Inc. Wauwatosa Wisconsin United States 53226
    18 UW Cancer Center-Riverview Wisconsin Rapids Wisconsin United States 54494

    Sponsors and Collaborators

    • University of Wisconsin, Madison
    • Millennium Pharmaceuticals, Inc.
    • Pfizer
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Brad S Kahl, MD, Universtity of Wisconsin- Madison
    • Study Chair: Timothy S Fenske, MD, Medical College of Wisconsin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT01281917
    Other Study ID Numbers:
    • HO10407
    • H-2010-0393
    • NCI-2011-00647
    • A534260
    • SMPH\MEDICINE\HEM-ONC
    First Posted:
    Jan 24, 2011
    Last Update Posted:
    Dec 13, 2019
    Last Verified:
    Jul 1, 2017
    Keywords provided by University of Wisconsin, Madison
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Patients with relapsed or refractory B-cell NHL were enrolled from 10 sites within the Wisconsin Oncology Network (WON) between May 2011 and May 2013.
    Pre-assignment Detail Forty participants were enrolled from 10 sites within the Wisconsin Oncology Network (WON) over 2 years. One participant withdrew consent immediately after enrollment and was never treated. Therefore, results are reported on the remaining 39 participants.
    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Period Title: Overall Study
    STARTED 40
    COMPLETED 39
    NOT COMPLETED 1

    Baseline Characteristics

    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Overall Participants 39
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    68
    Sex: Female, Male (Count of Participants)
    Female
    11
    28.2%
    Male
    28
    71.8%
    Region of Enrollment (participants) [Number]
    United States
    39
    100%
    Number of prior treatments (Prior treatments) [Median (Full Range) ]
    Median (Full Range) [Prior treatments]
    4
    Histology (Count of Participants)
    DLBCL
    18
    46.2%
    Follicular lymphoma
    9
    23.1%
    Mantle cell lymphoma
    7
    17.9%
    Small lymphocytic lymphoma
    3
    7.7%
    Marginal zone lymphoma
    2
    5.1%
    ECOG Performance Status (Count of Participants)
    0
    17
    43.6%
    1
    16
    41%
    2
    6
    15.4%

    Outcome Measures

    1. Primary Outcome
    Title Overall Response Rate
    Description The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
    Time Frame Up to 60 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Measure Participants 39
    Median (95% Confidence Interval) [Percentage of participants]
    31
    79.5%
    2. Primary Outcome
    Title Progression Free Survival
    Description The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).
    Time Frame Up to 60 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Measure Participants 39
    Median (95% Confidence Interval) [Months]
    4.7
    3. Secondary Outcome
    Title Safety of This Regimen
    Description Safety of the regimen will be measured by frequency and severity of adverse events.
    Time Frame Up to 36 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Measure Participants 39
    Grade 3 Adverse Events
    31
    79.5%
    Grade 4 Adverse Events
    2
    5.1%
    No Grade 3/4 Adverse Events
    6
    15.4%
    4. Secondary Outcome
    Title Complete Response Rate
    Description The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.
    Time Frame Up to 60 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Measure Participants 39
    Count of Participants [Participants]
    3
    7.7%
    5. Secondary Outcome
    Title Tolerability of the Regimen
    Description Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.
    Time Frame Up to 36 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Measure Participants 39
    Discontinued study due to an adverse event
    5
    12.8%
    Continued study
    34
    87.2%
    6. Secondary Outcome
    Title Duration of Response
    Description Duration of Response is how long a response to therapy is held before a subject has progressive disease.
    Time Frame Up to 60 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Measure Participants 39
    Median (95% Confidence Interval) [months]
    7
    7. Secondary Outcome
    Title Overall Survival
    Description Length of time from enrollment until death.
    Time Frame Up to 60 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    Measure Participants 39
    Median (95% Confidence Interval) [Months]
    14.1

    Adverse Events

    Time Frame Adverse events were collected for 3 years and 1 month.
    Adverse Event Reporting Description Adverse events were graded at each evaluation and are reported according to version 4 of the National Cancer Institute's Common Terminology Criteria for Adverse Events.
    Arm/Group Title Velcade Plus Temsirolimus
    Arm/Group Description Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. Velcade: Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus: Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
    All Cause Mortality
    Velcade Plus Temsirolimus
    Affected / at Risk (%) # Events
    Total 16/39 (41%)
    Serious Adverse Events
    Velcade Plus Temsirolimus
    Affected / at Risk (%) # Events
    Total 18/39 (46.2%)
    Blood and lymphatic system disorders
    Shaking chills/non neutropenic fever and chills 1/39 (2.6%) 1
    Temsirolimus 1/39 (2.6%) 1
    Cardiac disorders
    Heart Failure 2/39 (5.1%) 2
    Atrial fibrillation 1/39 (2.6%) 1
    Atrial flutter 1/39 (2.6%) 1
    Gastrointestinal disorders
    Constipation 2/39 (5.1%) 2
    Diarrhea 2/39 (5.1%) 2
    Ileus 1/39 (2.6%) 1
    Small intestinal obstruction 1/39 (2.6%) 1
    General disorders
    Fatigue 2/39 (5.1%) 2
    Fever 2/39 (5.1%) 2
    Edema limbs 1/39 (2.6%) 1
    Infections and infestations
    Sepsis 2/39 (5.1%) 2
    Lung infection 1/39 (2.6%) 1
    Metabolism and nutrition disorders
    Dehydration 1/39 (2.6%) 1
    Hypercalcemia 1/39 (2.6%) 1
    Nervous system disorders
    Palsy (right side of face) 1/39 (2.6%) 1
    Seizure 1/39 (2.6%) 1
    Syncope 1/39 (2.6%) 1
    Renal and urinary disorders
    Urinary Tract Infection 3/39 (7.7%) 3
    Acute Kidney Injury 2/39 (5.1%) 2
    Reproductive system and breast disorders
    Scrotal Pain 1/39 (2.6%) 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 2/39 (5.1%) 2
    Cough 1/39 (2.6%) 1
    Vascular disorders
    Thrombolic Event 1/39 (2.6%) 1
    Other (Not Including Serious) Adverse Events
    Velcade Plus Temsirolimus
    Affected / at Risk (%) # Events
    Total 35/39 (89.7%)
    Blood and lymphatic system disorders
    Anemia 13/39 (33.3%) 29
    Cardiac disorders
    Sinus tachycardia 3/39 (7.7%) 3
    Heart failure 2/39 (5.1%) 2
    Ear and labyrinth disorders
    Ear and labyrinth disorders - Other 2/39 (5.1%) 3
    Eye disorders
    Blurred vision 3/39 (7.7%) 4
    Conjunctivitis 3/39 (7.7%) 4
    Dry eye 2/39 (5.1%) 2
    Eye disorders - Other 2/39 (5.1%) 4
    Gastrointestinal disorders
    Nausea 18/39 (46.2%) 27
    Diarrhea 17/39 (43.6%) 32
    Vomiting 11/39 (28.2%) 15
    Constipation 10/39 (25.6%) 12
    Mucositis oral 9/39 (23.1%) 12
    Abdominal pain 8/39 (20.5%) 11
    Dry mouth 4/39 (10.3%) 4
    Dysphagia 4/39 (10.3%) 4
    Oral pain 4/39 (10.3%) 4
    Abdominal distension 3/39 (7.7%) 4
    Bloating 3/39 (7.7%) 3
    Gastrointestinal disorders - Other, specify 3/39 (7.7%) 3
    Fecal incontinence 2/39 (5.1%) 2
    Stomach pain 2/39 (5.1%) 3
    General disorders
    Fatigue 20/39 (51.3%) 36
    Chills 11/39 (28.2%) 20
    Edema limbs 11/39 (28.2%) 18
    Fever 7/39 (17.9%) 9
    General disorders and administration site conditions - Other, specify 2/39 (5.1%) 2
    Malaise 2/39 (5.1%) 2
    Non-cardiac chest pain 2/39 (5.1%) 2
    Pain 2/39 (5.1%) 2
    Infections and infestations
    Infections and infestations - Other 6/39 (15.4%) 7
    Lung infection 3/39 (7.7%) 3
    Bronchial infection 2/39 (5.1%) 2
    Peripheral nerve infection 2/39 (5.1%) 3
    Sepsis 2/39 (5.1%) 2
    Skin infection 2/39 (5.1%) 2
    Urinary tract infection 2/39 (5.1%) 3
    Injury, poisoning and procedural complications
    Bruising 4/39 (10.3%) 4
    Investigations
    Platelet count decreased 24/39 (61.5%) 82
    Neutrophil count decreased 18/39 (46.2%) 46
    White blood cell decreased 10/39 (25.6%) 28
    Lymphocyte count decreased 8/39 (20.5%) 19
    Creatinine increased 3/39 (7.7%) 3
    Investigations - Other, specify 3/39 (7.7%) 9
    Weight loss 3/39 (7.7%) 3
    Cholesterol high 2/39 (5.1%) 2
    Metabolism and nutrition disorders
    Anorexia 16/39 (41%) 22
    Dehydration 4/39 (10.3%) 4
    Hypoalbuminemia 4/39 (10.3%) 6
    Hypokalemia 4/39 (10.3%) 8
    Hypertriglyceridemia 3/39 (7.7%) 6
    Hyponatremia 3/39 (7.7%) 4
    Hypercalcemia 2/39 (5.1%) 2
    Hyperglycemia 2/39 (5.1%) 6
    Hypocalcemia 2/39 (5.1%) 6
    Musculoskeletal and connective tissue disorders
    Back pain 8/39 (20.5%) 8
    Musculoskeletal and connective tissue disorder - Other, specify 5/39 (12.8%) 7
    Pain in extremity 5/39 (12.8%) 12
    Myalgia 4/39 (10.3%) 4
    Arthralgia 3/39 (7.7%) 3
    Bone pain 3/39 (7.7%) 3
    Generalized muscle weakness 3/39 (7.7%) 3
    Chest wall pain 2/39 (5.1%) 2
    Nervous system disorders
    Peripheral sensory neuropathy 12/39 (30.8%) 18
    Dizziness 10/39 (25.6%) 13
    Headache 8/39 (20.5%) 8
    Dysgeusia 5/39 (12.8%) 5
    Ataxia 3/39 (7.7%) 4
    Nervous system disorders - Other, specify 3/39 (7.7%) 4
    Paresthesia 3/39 (7.7%) 3
    Neuralgia 2/39 (5.1%) 2
    Psychiatric disorders
    Insomnia 8/39 (20.5%) 10
    Anxiety 3/39 (7.7%) 3
    Depression 3/39 (7.7%) 3
    Agitation 2/39 (5.1%) 2
    Confusion 2/39 (5.1%) 2
    Delirium 2/39 (5.1%) 2
    Renal and urinary disorders
    Acute kidney injury 2/39 (5.1%) 2
    Renal and urinary disorders - Other, specify 2/39 (5.1%) 2
    Urinary incontinence 2/39 (5.1%) 2
    Urinary retention 2/39 (5.1%) 2
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 12/39 (30.8%) 14
    Cough 6/39 (15.4%) 8
    Productive cough 5/39 (12.8%) 6
    Sore throat 5/39 (12.8%) 5
    Epistaxis 4/39 (10.3%) 5
    Postnasal drip 3/39 (7.7%) 3
    Skin and subcutaneous tissue disorders
    Pruritus 8/39 (20.5%) 11
    Rash maculo-papular 8/39 (20.5%) 9
    Skin and subcutaneous tissue disorders - Other, specify 2/39 (5.1%) 2
    Skin ulceration 2/39 (5.1%) 2
    Vascular disorders
    Hypotension 6/39 (15.4%) 7
    Thromboembolic event 3/39 (7.7%) 3
    Hot flashes 2/39 (5.1%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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 Lymphoma Disease Oriented Team
    Organization University of Wisconsin Carbone Cancer Center
    Phone 608-265-5542
    Email neils@wisc.edu
    Responsible Party:
    University of Wisconsin, Madison
    ClinicalTrials.gov Identifier:
    NCT01281917
    Other Study ID Numbers:
    • HO10407
    • H-2010-0393
    • NCI-2011-00647
    • A534260
    • SMPH\MEDICINE\HEM-ONC
    First Posted:
    Jan 24, 2011
    Last Update Posted:
    Dec 13, 2019
    Last Verified:
    Jul 1, 2017