Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma
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
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:
Drug: Temsirolimus
Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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
- Safety of This Regimen [Up to 36 months]
Safety of the regimen will be measured by frequency and severity of adverse events.
- Complete Response Rate [Up to 60 months]
The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.
- 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.
- 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.
- Overall Survival [Up to 60 months]
Length of time from enrollment until death.
Eligibility Criteria
Criteria
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.- HO10407
- H-2010-0393
- NCI-2011-00647
- A534260
- SMPH\MEDICINE\HEM-ONC
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
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%
|
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
|
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%
|
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%
|
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%
|
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
|
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
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 |
neils@wisc.edu |
- HO10407
- H-2010-0393
- NCI-2011-00647
- A534260
- SMPH\MEDICINE\HEM-ONC