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Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT01075321
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : March 23, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Hepatosplenic T-cell Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Peripheral T-cell Lymphoma
Post-transplant Lymphoproliferative Disorder
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Adult T-cell Leukemia/Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Mycosis Fungoides/Sezary Syndrome
Splenic Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Interventions Drug: everolimus
Drug: lenalidomide
Other: laboratory biomarker analysis
Genetic: polymorphism analysis
Other: immunohistochemistry staining method
Genetic: microarray analysis
Genetic: fluorescence in situ hybridization
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I: Dose Level -1 Phase I: Dose Level 0 Phase I: Dose Level 1 Phase II: Dose Level 0
Hide Arm/Group Description Patients receive 5 mg oral everolimus once daily and 5 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 5 mg oral everolimus once daily and 15 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 7 9 9 33
Completed 6 9 7 31
Not Completed 1 0 2 2
Reason Not Completed
Withdrawal by Subject             0             0             1             1
Protocol Violation             0             0             1             0
Treatment Incomplete due to progression             1             0             0             0
Ineligible (miscalculated lab value)             0             0             0             1
Arm/Group Title All Patients (Everolimus and Lenalidomide)
Hide Arm/Group Description Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
Fifty-five patients began study treatment and were eligible for response evaluation were pooled and included in this analysis.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 55 participants
62
(21 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
17
  30.9%
Male
38
  69.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
54
  98.2%
More than one race
1
   1.8%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants
55
1.Primary Outcome
Title Number of Patients Reporting Dose-Limiting Toxicity (DLT) (Phase I)
Hide Description The number of dose-limiting toxic events (DLT) for this combination of drug treatment will determine the Maximum Tolerated Dose (MTD) in subsequent phases of this study. The following events were defined as a DLT: a grade 4+ Neutropenia or platelet count decrease, a grade 4 infection, or any grade 3+ non-hematologic event as assessed using Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. Here, the number of patients reporting a DLT are reported
Time Frame After one 28 day cycle
Hide Outcome Measure Data
Hide Analysis Population Description
All Phase 1 patients that began treatment, completed 1 cycle, and were evaluated for cycle 1 toxicity were included in this analysis. Of the 9 registered to Dose Level 1, 2 were ineligible for this endpoint (PD before evaluated and dose error) and 1 cancelled. Phase II patients were not evaluated for dose-limiting toxicity.
Arm/Group Title Phase I: Dose Level -1 Phase I: Dose Level 0 Phase I: Dose Level 1 Phase II: Dose Level 0
Hide Arm/Group Description:
Patients receive 5 mg oral everolimus once daily and 5 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Patients receive 5 mg oral everolimus once daily and 15 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 6 9 6 0
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
2
  22.2%
3
  50.0%
 0
2.Primary Outcome
Title Best Response to Dose Level 0
Hide Description Patients were assessed using the Cheson et al. Revised Response Criteria for Malignant Lymphoma (Cheson, et al 2007). A Complete Response (CR) was defined as the disappearance of all evidence of disease, no palpable nodules and bone marrow cleared on biopsy. A Partial Response (PR) was defined as regression of measureable disease and no new sites, with a 50% decrease in sum of the products of dimension (SPD) of nodal masses, and no increase in spleen or liver size. Patients with Waldenstrom's Macroglobulinemia were eligible to be evaluated as a Minor Response (MR) in which a reduction between 25% and 50% of serum monoclonal IgM was observed. A Progression (PD) was defined as having any new lesions or a 50% increase in the SPD of any previously involved nodes. A Stable Disease (SD) is the absence of any of the previously defined responses.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that were registered and treated at Dose Level 0 were pooled and included in this endpoint. 9 patients in Phase I and 32 patients in Phase II were treated and evaluable for this endpoint
Arm/Group Title Dose Level 0
Hide Arm/Group Description:
Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 41
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
4
   9.8%
Partial Response
8
  19.5%
Minor Response
1
   2.4%
Stable Disease
16
  39.0%
Progression
12
  29.3%
3.Secondary Outcome
Title Overall Survival for All Eligible Patients
Hide Description Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Fifty-five patients began study treatment and were eligible for response evaluation were pooled and included in this analysis.
Arm/Group Title All Patients (Everolimus and Lenalidomide)
Hide Arm/Group Description:
Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 55
Median (95% Confidence Interval)
Unit of Measure: months
20.3
(8.7 to 51.3)
4.Secondary Outcome
Title Progression-Free Survival For All Eligible Patients
Hide Description Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. The distribution of progression-free survival time will be estimated using the method of Kaplan-Meier.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Fifty-five patients began study treatment and were eligible for response evaluation were pooled and included in this analysis.
Arm/Group Title All Patients (Everolimus and Lenalidomide)
Hide Arm/Group Description:
Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 55
Median (95% Confidence Interval)
Unit of Measure: months
5.3
(3.0 to 7.0)
5.Secondary Outcome
Title Duration of Response for All Eligible Patients
Hide Description Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's earliest objective status is first noted to be either a CR or PR to the earliest date progression is documented.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients that began study treatment and evaluated as a CR, PR or MR during treatment were included in this analysis.
Arm/Group Title All Patients (Everolimus and Lenalidomide)
Hide Arm/Group Description:
Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: months
14.7
(2.8 to 22.0)
6.Secondary Outcome
Title Time to Treatment Failure for All Eligible Patients
Hide Description Time to treatment failure is defined to be the time from registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Fifty-five patients began study treatment and were eligible for response evaluation were pooled and included in this analysis.
Arm/Group Title All Patients (Everolimus and Lenalidomide)
Hide Arm/Group Description:
Patients receive oral everolimus once daily and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 55
Median (95% Confidence Interval)
Unit of Measure: months
4.7
(2.2 to 6.6)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events (AEs) were assessed at the end of every 28 day cycle of treatment. Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who did NOT withdraw from the study (i.e. Withdrawal by Subject in participant flow) and did not have protocol violation (i.e. Protocol Violation in participant flow). All-cause mortality is assessed for participants who did NOT withdraw from the study (i.e. Withdrawal by Subject in participant flow).
 
Arm/Group Title Phase I: Dose Level -1 Phase I: Dose Level 0 Phase I: Dose Level 1 Phase II: Dose Level 0
Hide Arm/Group Description Patients receive 5 mg oral everolimus once daily and 5 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 5 mg oral everolimus once daily and 15 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients receive 5 mg oral everolimus once daily and 10 mg oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Phase I: Dose Level -1 Phase I: Dose Level 0 Phase I: Dose Level 1 Phase II: Dose Level 0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/7 (85.71%)      6/9 (66.67%)      7/8 (87.50%)      18/32 (56.25%)    
Hide Serious Adverse Events
Phase I: Dose Level -1 Phase I: Dose Level 0 Phase I: Dose Level 1 Phase II: Dose Level 0
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/7 (42.86%)      7/9 (77.78%)      5/7 (71.43%)      14/32 (43.75%)    
Blood and lymphatic system disorders         
Febrile neutropenia † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/32 (3.13%)  1
Gastrointestinal disorders         
Colitis † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Duodenal obstruction † 1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/32 (0.00%)  0
Mucositis oral † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Nausea † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Obstruction gastric † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
General disorders         
Edema limbs † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Fatigue † 1  2/7 (28.57%)  2 0/9 (0.00%)  0 1/7 (14.29%)  1 1/32 (3.13%)  1
Fever † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Infections and infestations         
Abdominal infection † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Appendicitis † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Lung infection † 1  1/7 (14.29%)  1 3/9 (33.33%)  3 0/7 (0.00%)  0 0/32 (0.00%)  0
Mucosal infection † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Otitis externa † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Otitis media † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Pharyngitis † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Sepsis † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 2/7 (28.57%)  2 1/32 (3.13%)  1
Skin infection † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Upper respiratory infection † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 1/32 (3.13%)  1
Investigations         
Electrocardiogram QT corrected interval prolonged † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Lymphocyte count decreased † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Neutrophil count decreased † 1  1/7 (14.29%)  1 3/9 (33.33%)  3 2/7 (28.57%)  2 5/32 (15.63%)  5
Platelet count decreased † 1  1/7 (14.29%)  1 2/9 (22.22%)  2 1/7 (14.29%)  1 3/32 (9.38%)  4
Weight loss † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
White blood cell decreased † 1  1/7 (14.29%)  1 3/9 (33.33%)  3 1/7 (14.29%)  1 3/32 (9.38%)  3
Metabolism and nutrition disorders         
Anorexia † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Dehydration † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Hypertriglyceridemia † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify † 1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/32 (0.00%)  0
Nervous system disorders         
Seizure † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Syncope † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Respiratory, thoracic and mediastinal disorders         
Pneumonitis † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Skin and subcutaneous tissue disorders         
Rash acneiform † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Vascular disorders         
Thromboembolic event † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
1
Term from vocabulary, MedDRA 12
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Phase I: Dose Level -1 Phase I: Dose Level 0 Phase I: Dose Level 1 Phase II: Dose Level 0
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/7 (85.71%)      9/9 (100.00%)      7/7 (100.00%)      32/32 (100.00%)    
Blood and lymphatic system disorders         
Anemia † 1  1/7 (14.29%)  1 4/9 (44.44%)  12 2/7 (28.57%)  2 8/32 (25.00%)  27
Blood and lymphatic system disorders - Other, specify † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Febrile neutropenia † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Ear and labyrinth disorders         
Ear pain † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
External ear inflammation † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Endocrine disorders         
Hypothyroidism † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  3
Gastrointestinal disorders         
Ascites † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Diarrhea † 1  3/7 (42.86%)  5 6/9 (66.67%)  9 0/7 (0.00%)  0 17/32 (53.13%)  61
Gastroesophageal reflux disease † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Gastrointestinal disorders - Other, specify † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Mucositis oral † 1  2/7 (28.57%)  3 2/9 (22.22%)  6 2/7 (28.57%)  3 6/32 (18.75%)  15
Nausea † 1  3/7 (42.86%)  5 4/9 (44.44%)  9 4/7 (57.14%)  5 17/32 (53.13%)  39
Toothache † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Vomiting † 1  2/7 (28.57%)  2 3/9 (33.33%)  5 3/7 (42.86%)  3 9/32 (28.13%)  12
General disorders         
Chills † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Edema face † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Edema limbs † 1  3/7 (42.86%)  11 5/9 (55.56%)  23 2/7 (28.57%)  2 13/32 (40.63%)  32
Fatigue † 1  6/7 (85.71%)  22 7/9 (77.78%)  38 7/7 (100.00%)  11 27/32 (84.38%)  178
Fever † 1  1/7 (14.29%)  2 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Pain † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Immune system disorders         
Allergic reaction † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Infections and infestations         
Infections and infestations - Other, specify † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Lung infection † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Mucosal infection † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Peripheral nerve infection † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Pharyngitis † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Pleural infection † 1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/32 (0.00%)  0
Rhinitis infective † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Skin infection † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Tooth infection † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  2
Upper respiratory infection † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 2/32 (6.25%)  3
Investigations         
Alkaline phosphatase increased † 1  1/7 (14.29%)  1 1/9 (11.11%)  1 0/7 (0.00%)  0 2/32 (6.25%)  2
Blood bilirubin increased † 1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 1/32 (3.13%)  2
CD4 lymphocytes decreased † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Cholesterol high † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
INR increased † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Lymphocyte count decreased † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  6 10/32 (31.25%)  32
Neutrophil count decreased † 1  3/7 (42.86%)  12 8/9 (88.89%)  43 4/7 (57.14%)  14 25/32 (78.13%)  159
Platelet count decreased † 1  3/7 (42.86%)  16 9/9 (100.00%)  68 5/7 (71.43%)  15 23/32 (71.88%)  140
Weight loss † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 2/32 (6.25%)  8
White blood cell decreased † 1  4/7 (57.14%)  18 8/9 (88.89%)  52 6/7 (85.71%)  17 26/32 (81.25%)  137
Metabolism and nutrition disorders         
Anorexia † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 1/7 (14.29%)  1 2/32 (6.25%)  3
Dehydration † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Hyperglycemia † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 2/32 (6.25%)  2
Hypertriglyceridemia † 1  1/7 (14.29%)  3 0/9 (0.00%)  0 1/7 (14.29%)  1 2/32 (6.25%)  7
Hypokalemia † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  2
Hyponatremia † 1  1/7 (14.29%)  1 1/9 (11.11%)  1 0/7 (0.00%)  0 0/32 (0.00%)  0
Nervous system disorders         
Dizziness † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Dysgeusia † 1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/32 (0.00%)  0
Syncope † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Renal and urinary disorders         
Urinary tract obstruction † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 1/7 (14.29%)  1 0/32 (0.00%)  0
Reproductive system and breast disorders         
Reproductive system and breast disorders - Other, specify † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  1
Respiratory, thoracic and mediastinal disorders         
Allergic rhinitis † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  2
Cough † 1  4/7 (57.14%)  12 6/9 (66.67%)  18 5/7 (71.43%)  7 23/32 (71.88%)  67
Dyspnea † 1  5/7 (71.43%)  9 6/9 (66.67%)  13 2/7 (28.57%)  3 17/32 (53.13%)  52
Pneumonitis † 1  1/7 (14.29%)  2 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Pulmonary edema † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Sore throat † 1  1/7 (14.29%)  1 1/9 (11.11%)  1 0/7 (0.00%)  0 1/32 (3.13%)  1
Skin and subcutaneous tissue disorders         
Bullous dermatitis † 1  0/7 (0.00%)  0 0/9 (0.00%)  0 0/7 (0.00%)  0 1/32 (3.13%)  2
Rash acneiform † 1  4/7 (57.14%)  8 2/9 (22.22%)  2 3/7 (42.86%)  3 18/32 (56.25%)  43
Rash maculo-papular † 1  0/7 (0.00%)  0 1/9 (11.11%)  1 0/7 (0.00%)  0 0/32 (0.00%)  0
Vascular disorders         
Hypertension † 1  1/7 (14.29%)  1 0/9 (0.00%)  0 0/7 (0.00%)  0 0/32 (0.00%)  0
Thromboembolic event † 1  0/7 (0.00%)  0 1/9 (11.11%)  1 1/7 (14.29%)  1 1/32 (3.13%)  3
1
Term from vocabulary, MedDRA 12
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Craig B. Reeder MD
Organization: Mayo Clinic
Phone: 480.301.8000
EMail: Reeder.Craig@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01075321    
Other Study ID Numbers: MC0981
NCI-2010-00235 ( Registry Identifier: NCI-CTRP )
09-003801 ( Other Identifier: Mayo Clinic IRB )
RV-NHL-HL-PI-0466 ( Other Identifier: Celgene Protocol )
CRAD001NUS113T ( Other Identifier: Novartis Protocol )
MC0981 ( Other Identifier: Mayo Clinic Cancer Center )
First Submitted: February 23, 2010
First Posted: February 25, 2010
Results First Submitted: August 21, 2018
Results First Posted: March 23, 2020
Last Update Posted: October 22, 2020