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Rituximab, Lenalidomide, and Bortezomib in Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00633594
Recruitment Status : Completed
First Posted : March 12, 2008
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Celgene
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mantle Cell Lymphoma
Interventions Drug: Rituximab
Drug: Bortezomib
Drug: Lenalidomide
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I - Lenalidomide 15mg PO QD Phase I - Lenalidomide 10mg PO QD Phase II - Lenalidomide 10mg PO QD
Hide Arm/Group Description Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1-14. Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14. Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
Period Title: Overall Study
Started 5 8 26
Completed 5 3 16
Not Completed 0 5 10
Reason Not Completed
Adverse Event             0             4             7
Death             0             1             2
Disease Progression             0             0             1
Arm/Group Title Phase I - Lenalidomide 15mg PO QD Phase I - Lenalidomide 10mg PO QD Phase II - Lenalidomide 10mg PO QD Total
Hide Arm/Group Description Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. . Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14. Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14. Total of all reporting groups
Overall Number of Baseline Participants 5 8 26 39
Hide Baseline Analysis Population Description
Based on efficacy evaluable population, all participants that received any study therapy. Participants were stratified based on phase of study (Phase I vs Phase II) and previous treatment status prior to study start (Previously Untreated vs Previously Treated (relapsed or refractory))
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 8 participants 26 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  60.0%
2
  25.0%
7
  26.9%
12
  30.8%
>=65 years
2
  40.0%
6
  75.0%
19
  73.1%
27
  69.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants 8 participants 26 participants 39 participants
60
(52 to 70)
69
(60 to 80)
69
(55 to 88)
69
(52 to 88)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 8 participants 26 participants 39 participants
Previously Treated : <= 18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Previously Treated : Between 18 and 65 years
3
  60.0%
0
   0.0%
0
   0.0%
3
   7.7%
Previously Treated : >= 65 years
1
  20.0%
1
  12.5%
5
  19.2%
7
  17.9%
Previously Untreated : <= 18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Previously Untreated : Between 18 and 65 years
0
   0.0%
2
  25.0%
7
  26.9%
9
  23.1%
Previously Untreated : >= 65 years
1
  20.0%
5
  62.5%
14
  53.8%
20
  51.3%
Sex/Gender, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 8 participants 26 participants 39 participants
Previously Treated : Female
1
  20.0%
1
  12.5%
2
   7.7%
4
  10.3%
Previously Treated : Male
3
  60.0%
0
   0.0%
3
  11.5%
6
  15.4%
Previously Untreated : Female
0
   0.0%
1
  12.5%
5
  19.2%
6
  15.4%
Previously Untreated : Male
1
  20.0%
6
  75.0%
16
  61.5%
23
  59.0%
[1]
Measure Description: Gender based on participants' previous treatment prior to initiating study treatment (previously treated and previously untreated)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 8 participants 26 participants 39 participants
Female
1
  20.0%
2
  25.0%
7
  26.9%
10
  25.6%
Male
4
  80.0%
6
  75.0%
19
  73.1%
29
  74.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 8 participants 26 participants 39 participants
5 8 26 39
Previous Treatment for Mantle Cell Lymphoma (MCL)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5 participants 8 participants 26 participants 39 participants
Previously Untreated 1 7 21 29
Previously Treated 4 1 5 10
[1]
Measure Description: Includes participants with relapsed or refractory MCL who have received one previous treatment prior to starting study treatment, and those with previously untreated MCL prior to starting study treatment.
1.Primary Outcome
Title Maximum Tolerated Dose of Lenalidomide Combined With Bortezomib and Rituximab in Phase I Participants
Hide Description

Determination of the maximum tolerated dose (MTD) of lenalidomide combined with bortezomib and rituximab, defined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity according to the NCI CTCAE v. 4.03.

MTD of Lenalidomide was tested, included with 1.3 mg/m2 subcutaneous (D1, 4, 8, 11) bortezomib, 375 mg/m2 (D1, 8, 15 of Cycle 1, D1 on subsequent cycles) rituximab.

Three dose limiting toxicities were reported in two patients (grade 4 neutropenia and grade 3 neuropathy, grade 3 rash)

Time Frame Collected from day of first dose to the end of the first treatment cycle, up to 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients that were enrolled in both lenalidomide dose levels (10 mg PO daily, 15 mg PO daily) in the Phase I portion of the study
Arm/Group Title Phase I Participants (10 mg/15 mg Lenalidomide)
Hide Arm/Group Description:

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.

Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)

Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: mg lenalidomide, orally, daily, day 1-14
10
2.Primary Outcome
Title Incidence of Non-Serious Adverse Events as a Measure of Safety and Tolerability, Phase II
Hide Description

A count of affected participants with non-serious adverse events (regardless of relationship to study treatments) occurring in >= 15% of treated patients enrolled in the Phase II section of the study.

Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 subcutaneous Days 1, 4, 8, and 11 for Cycles 1-6

Time Frame Collected from day of first dose to 30 days after the last dose of study medication, a maximum of 18 weeks and 30 days after last study treatment
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Hide Analysis Population Description
Includes patients that were enrolled in the Phase II section of the study
Arm/Group Title Phase II - Lenalidomide 10mg PO QD
Hide Arm/Group Description:
Lenalidomide DL-1 dose (10 mg orally, once daily (PO QD)) Day 1-14 followed by 7 days of rest, Rituximab 375 mg/m2 IV Days 1, 8, and 15 of Cycle 1; Cycles 2-6: 375 mg/m2 IV Day 1, Bortezomib 1.3 mg/m2 IV Days 1, 4, 8, and 11 for Cycles 1-6
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
Rash 19
Fatigue 18
Thrombocytopenia 16
Leukopenia 13
Nausea 12
Diarrhea 11
Edema 11
Hyperglycemia 11
Peripheral Neuropathy 10
Neutropenia 10
Hypoalbuminemia 10
Constipation 9
Hypocalcemia 9
Pain in Extremity 9
Anemia 8
Cough 8
Fever 8
Dehydration 7
Pruritus 7
Dyspnea 7
Hyponatremia 7
Insomnia 6
Abdominal Pain 6
Dizziness 6
Hypokalemia 6
Weight Loss 6
Anorexia 5
Erythema 5
Hypomagnesemia 5
Allergic Reaction 5
Chills 5
Hyperhidrosis 5
Myalgia 4
Headache 4
Mucositis 4
Hypoglycemia 4
3.Secondary Outcome
Title Overall Response Rate (ORR) of Phase I and Phase II Participants
Hide Description Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.
Time Frame Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months
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Hide Analysis Population Description
The efficacy evaluable population (all participants who have received any study treatment)
Arm/Group Title Phase I Participants (10 mg/15 mg Lenalidomide) Phase II Participants (10 mg Lenalidomide)
Hide Arm/Group Description:

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.

Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
Overall Number of Participants Analyzed 13 26
Measure Type: Count of Participants
Unit of Measure: Participants
12
  92.3%
21
  80.8%
4.Secondary Outcome
Title Overall Response Rate (ORR) of Previously Treated and Previously Untreated Participants
Hide Description Response to treatment (Complete Response (CR) or Partial Response (PR)) determined using Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses, no increase in the size of other nodes, liver or spleen, no new sites of disease, patients who achieve CR but have persistent morphologic bone marrow involvement; Stable Disease (SD): failing to attain PR or CR, but not fulfilling criteria for progressive disease; Progressive Disease (PD)/Relapse: appearance of new lesions more than 1.5 cm in any axis, 50% or greater increase from nadir SPD of any previously involved sites, 50% or greater increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in short axis.
Time Frame Every 6 weeks until treatment discontinuation then every 3 months thereafter, projected average 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy evaluable population (all participants who have received any study treatment)
Arm/Group Title Previously Treated Participants Previously Untreated Participants
Hide Arm/Group Description:

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.

Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.

Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD

Overall Number of Participants Analyzed 10 29
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
25
  86.2%
5.Secondary Outcome
Title Time to Best Response of Phase I and Phase II Participants
Hide Description

Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.

Time to Best Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification.

Time Frame Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received study treatment that were evaluable for a response assessment (one participant in Phase I and two participants in Phase II were considered unevaluable, discontinuing prior to first post-baseline response assessment)
Arm/Group Title Phase I Participants (10 mg/15 mg Lenalidomide) Phase II Participants (10 mg Lenalidomide)
Hide Arm/Group Description:

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.

Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
Overall Number of Participants Analyzed 12 24
Median (Full Range)
Unit of Measure: days
63.50
(59.00 to 169.00)
71.50
(47.00 to 523.00)
6.Secondary Outcome
Title Time to Best Response of Previously Treated and Previously Untreated Participants
Hide Description Measured from the time of study entry to the documented beginning of response (CR or PR). This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.
Time Frame Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that received study treatment that were evaluable for a response assessment (2 previously untreated participants and 1 previously treated participant were considered unevaluable, discontinuing prior to first post-baseline response assessment)
Arm/Group Title Previously Treated Participants Previously Untreated Participants
Hide Arm/Group Description:

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.

Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.

Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD

Overall Number of Participants Analyzed 10 29
Median (95% Confidence Interval)
Unit of Measure: months
2.04
(1.5441 to 4.2710)
2.37
(2.0370 to 4.2053)
7.Secondary Outcome
Title Duration of Response (DoR) of Phase I and Phase II Participants
Hide Description

Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.

Duration of Response will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification.

Time Frame Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received study treatment that were responders (achieved a PR or better)
Arm/Group Title Phase I Participants (10 mg/15 mg Lenalidomide) Phase II Participants (10 mg Lenalidomide)
Hide Arm/Group Description:

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.

Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
Overall Number of Participants Analyzed 12 21
Median (95% Confidence Interval)
Unit of Measure: months
25.72
(5.3224 to 52.665)
17.81
(4.6982 to 21.092)
8.Secondary Outcome
Title Duration of Response (DoR) of Previously Treated and Previously Untreated Participants
Hide Description Measured from the documented beginning of response (CR or PR) to the time of relapse. This is measured in responders per Non-Hodgkin's Lymphoma Revised Response Criteria for Malignant Lymphoma (Cheson et al. 2007.) CR: complete disappearance of detectable clinical evidence of disease and disease-related symptoms; PR: 50% or greater decrease in sum of product of diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses, no increase in size of other nodes, liver or spleen, no new disease sites, patients with CR and persistent morphologic bone marrow involvement.
Time Frame Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years or until documented disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received study treatment that were responders (achieved a PR or better)
Arm/Group Title Previously Treated Participants Previously Untreated Participants
Hide Arm/Group Description:

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.

Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.

Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD

Overall Number of Participants Analyzed 8 25
Median (95% Confidence Interval)
Unit of Measure: months
17.94
(2.8583 to 46.982)
21.09
(5.6509 to 52.665)
9.Secondary Outcome
Title Progression Free Survival (PFS) of Phase I and Phase II Participants
Hide Description

Defined as the time from entry onto study until lymphoma progression or death from any cause.

Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification.

Time Frame Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received study treatment
Arm/Group Title Phase I Participants (10 mg/15 mg Lenalidomide) Phase II Participants (10 mg Lenalidomide)
Hide Arm/Group Description:

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg PO daily on Days 1-14.

Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
Overall Number of Participants Analyzed 13 26
Median (95% Confidence Interval)
Unit of Measure: months
27.70
(7.2608 to 55.097)
19.35
(7.5236 to 25.298)
10.Secondary Outcome
Title Progression Free Survival (PFS) of Previously Treated and Previously Untreated Participants
Hide Description

Defined as the time from entry onto study until lymphoma progression or death from any cause.

Progression Free Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification.

Time Frame Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received study treatment
Arm/Group Title Previously Treated Participants Previously Untreated Participants
Hide Arm/Group Description:

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.

Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.

Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD

Overall Number of Participants Analyzed 10 29
Median (95% Confidence Interval)
Unit of Measure: months
12.4517
(0.4271 to 27.6632)
25.2649
(7.4908 to 60.4189)
11.Secondary Outcome
Title Overall Survival of Phase I and Phase II Participants
Hide Description

Defined as the date of study entry to the date of death.

Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification

Time Frame Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
all participants that received study treatment
Arm/Group Title Phase I Participants (10 mg/15 mg Lenalidomide) Phase II Participants (10 mg Lenalidomide)
Hide Arm/Group Description:

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 or 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 or 15mg PO daily on Days 1-14.

Includes participants tested on two separate dose levels, 15 mg by mouth (PO) daily (5 participants) or 10 mg PO daily (8 participants)

Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1-14.
Overall Number of Participants Analyzed 13 26
Median (95% Confidence Interval)
Unit of Measure: months
51.45
(21.520 to 71.294)
35.35 [1] 
(22.374 to NA)
[1]
Not applicable (N/A) was reported as the maximum of the 95% confidence interval due to having insufficient data to provide the upper confidence limit estimate
12.Secondary Outcome
Title Overall Survival of Previously Treated and Previously Untreated Participants
Hide Description

Defined as the date of study entry to the date of death.

Overall Survival will be examined using time-to-event analysis methods. Kaplan-Meier figures will be generated and the log-rank test will be used to examine differences existing between various levels of stratification

Time Frame Every 3 months (+/- 2 weeks) after discontinuation of study treatment for 2 years, then every 6 months after documented disease progression
Hide Outcome Measure Data
Hide Analysis Population Description
all participants that received study treatment
Arm/Group Title Previously Treated Participants Previously Untreated Participants
Hide Arm/Group Description:

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who were refractory to/relapsed from their previous treatment.

Includes 4 participants in Phase I - Lenalidomide15 mg PO QD, 1 participant in Phase I - Lenlidomide10 mg PO QD and 5 participants in Phase II - Lenalidomide 10 mg PO QD

The efficacy evaluable population (all patients who have received any study treatment) in Phase I and Phase II of the study who not received any previous treatment prior to initiating study treatment.

Includes 1 participant in Phase I - Lenalidomide15 mg PO QD, 7 participants in Phase I - Lenlidomide10 mg PO QD and 21 participants in Phase II - Lenalidomide 10 mg PO QD

Overall Number of Participants Analyzed 10 29
Median (95% Confidence Interval)
Unit of Measure: months
28.4189
(0.4271 to 51.4168)
71.2608
(35.3183 to 71.2608)
Time Frame 8 years
Adverse Event Reporting Description Time frame from the initiation of study treatment for the first patient enrolled until all patients off-treatment into the survival follow-up interval
 
Arm/Group Title Phase I - Lenalidomide 15mg PO QD Phase I - Lenalidomide 10mg PO QD Phase II - Lenalidomide 10mg PO QD
Hide Arm/Group Description Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 15 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 15 mg PO daily on Days 1 14. Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14. Cycle 1: rituximab 375 mg/m2 intravenously (IV) on Days 1, 8, and 15; bortezomib 1.3 mg/ m2 subcutaneously (SC) on Days 1, 4, 8, and 11; and lenalidomide 10 mg by mouth (PO) daily on Days 1-14. Cycles 2 – 6: rituximab 375 mg/m2 IV on Day 1; bortezomib 1.3 mg/ m2 SC on Days 1, 4, 8, and 11; and lenalidomide 10 mg PO daily on Days 1 14.
All-Cause Mortality
Phase I - Lenalidomide 15mg PO QD Phase I - Lenalidomide 10mg PO QD Phase II - Lenalidomide 10mg PO QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase I - Lenalidomide 15mg PO QD Phase I - Lenalidomide 10mg PO QD Phase II - Lenalidomide 10mg PO QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/5 (40.00%)   6/8 (75.00%)   13/26 (50.00%) 
Blood and lymphatic system disorders       
Febrile Neutropenia * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Platelet Count Decreased * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Cardiac disorders       
Cardiac Ischemia/Infarction * 1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Gastrointestinal disorders       
Colitis * 1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Diarrhea * 1  0/5 (0.00%)  1/8 (12.50%)  1/26 (3.85%) 
Esophagitis * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Gastrointestinal- Intussusception * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Pancreatitis * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
General disorders       
Death * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Fever * 1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
Opioid Withdrawal * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Pain- Non Cardiac Chest * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Pain- NOS * 1  1/5 (20.00%)  0/8 (0.00%)  0/26 (0.00%) 
Infections and infestations       
Clostridium Difficile * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Infection- Lung (Pneumonia) * 1  0/5 (0.00%)  1/8 (12.50%)  2/26 (7.69%) 
Infection- Pyelonephritis * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Infection- Septic Shock * 1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Infection- Varicella * 1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
Infection- Viral Syndrome * 1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Metabolism and nutrition disorders       
Tumor Lysis Syndrome * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Secondary Malignancy- Squamous Cell Carcinoma * 1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Nervous system disorders       
Encephalopathy * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Syncope * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Psychiatric disorders       
Mental Status Change * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Renal and urinary disorders       
Acute Kidney Injury * 1  0/5 (0.00%)  1/8 (12.50%)  1/26 (3.85%) 
Acute Renal Failure * 1  0/5 (0.00%)  0/8 (0.00%)  1/26 (3.85%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea * 1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
Pleural Effusion * 1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash * 1  1/5 (20.00%)  0/8 (0.00%)  0/26 (0.00%) 
Vascular disorders       
Hypotension * 1  0/5 (0.00%)  1/8 (12.50%)  1/26 (3.85%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I - Lenalidomide 15mg PO QD Phase I - Lenalidomide 10mg PO QD Phase II - Lenalidomide 10mg PO QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   8/8 (100.00%)   25/26 (96.15%) 
Blood and lymphatic system disorders       
ANEMIA  1  1/5 (20.00%)  2/8 (25.00%)  8/26 (30.77%) 
LEUKOPENIA  1  0/5 (0.00%)  1/8 (12.50%)  13/26 (50.00%) 
NEUTROPENIA  1  1/5 (20.00%)  4/8 (50.00%)  10/26 (38.46%) 
SPLENOMEGALY  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
THROMBOCYTOPENIA  1  4/5 (80.00%)  4/8 (50.00%)  16/26 (61.54%) 
Cardiac disorders       
ATRIAL FIBRILLATION  1  0/5 (0.00%)  1/8 (12.50%)  1/26 (3.85%) 
BRADYCARDIA  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
HEART FAILURE  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
TACHYCARDIA  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
Eye disorders       
BLURRED VISION  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
EYELID DYSFUNCTION  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
VISION CHANGE  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
WATERING EYES  1  1/5 (20.00%)  0/8 (0.00%)  0/26 (0.00%) 
Gastrointestinal disorders       
ABDOMINAL DISTENSION  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
ABDOMINAL PAIN  1  0/5 (0.00%)  2/8 (25.00%)  6/26 (23.08%) 
CONSTIPATION  1  1/5 (20.00%)  3/8 (37.50%)  9/26 (34.62%) 
DIARRHEA  1  2/5 (40.00%)  4/8 (50.00%)  11/26 (42.31%) 
DRY MOUTH  1  0/5 (0.00%)  0/8 (0.00%)  3/26 (11.54%) 
DYSPEPSIA  1  0/5 (0.00%)  2/8 (25.00%)  0/26 (0.00%) 
DYSPHAGIA  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
ESOPHAGITIS  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
GASTROINTESTINAL DISORDER  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
GASTROINTESTINAL HEMORRHAGE  1  0/5 (0.00%)  1/8 (12.50%)  1/26 (3.85%) 
MUCOSITIS  1  0/5 (0.00%)  1/8 (12.50%)  4/26 (15.38%) 
NAUSEA  1  1/5 (20.00%)  5/8 (62.50%)  12/26 (46.15%) 
ORAL PAIN  1  0/5 (0.00%)  1/8 (12.50%)  1/26 (3.85%) 
SORE THROAT  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
STOMACH PAIN  1  1/5 (20.00%)  0/8 (0.00%)  2/26 (7.69%) 
VOMITING  1  0/5 (0.00%)  2/8 (25.00%)  3/26 (11.54%) 
General disorders       
ASTHENIA  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
CHEST PAIN  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
CHILLS  1  0/5 (0.00%)  0/8 (0.00%)  5/26 (19.23%) 
EDEMA  1  1/5 (20.00%)  3/8 (37.50%)  11/26 (42.31%) 
FATIGUE  1  5/5 (100.00%)  7/8 (87.50%)  18/26 (69.23%) 
FEVER  1  0/5 (0.00%)  2/8 (25.00%)  8/26 (30.77%) 
HOT FLASHES  1  0/5 (0.00%)  0/8 (0.00%)  3/26 (11.54%) 
HYPOTHERMIA  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
PAIN  1  0/5 (0.00%)  1/8 (12.50%)  2/26 (7.69%) 
Hepatobiliary disorders       
HYPERBILIRUBINEMIA  1  0/5 (0.00%)  0/8 (0.00%)  3/26 (11.54%) 
Immune system disorders       
ALLERGIC REACTION  1  0/5 (0.00%)  0/8 (0.00%)  5/26 (19.23%) 
ALLERGIC REACTION (INSECT BITE)  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Infections and infestations       
HERPES ZOSTER  1  1/5 (20.00%)  1/8 (12.50%)  3/26 (11.54%) 
INFECTION  1  0/5 (0.00%)  0/8 (0.00%)  3/26 (11.54%) 
SINUS INFECTION  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
UPPER RESPIRATORY INFECTION  1  0/5 (0.00%)  1/8 (12.50%)  3/26 (11.54%) 
VAGINAL INFECTION  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Investigations       
ALANINE AMINOTRANSFERASE INCREASED  1  0/5 (0.00%)  0/8 (0.00%)  3/26 (11.54%) 
ALKALINE PHOSPHATASE INCREASED  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
ASPARTATE AMINOTRANSFERASE INCREASED  1  0/5 (0.00%)  0/8 (0.00%)  3/26 (11.54%) 
CREATININE LEVELS DECREASED  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
HEMATOCRIT DECREASED  1  1/5 (20.00%)  0/8 (0.00%)  0/26 (0.00%) 
WEIGHT LOSS  1  1/5 (20.00%)  0/8 (0.00%)  6/26 (23.08%) 
Metabolism and nutrition disorders       
ANOREXIA  1  1/5 (20.00%)  2/8 (25.00%)  5/26 (19.23%) 
DEHYDRATION  1  2/5 (40.00%)  3/8 (37.50%)  7/26 (26.92%) 
DIABETES  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
HYPERGLYCEMIA  1  0/5 (0.00%)  1/8 (12.50%)  11/26 (42.31%) 
HYPERKALEMIA  1  0/5 (0.00%)  0/8 (0.00%)  3/26 (11.54%) 
HYPERNATREMIA  1  0/5 (0.00%)  0/8 (0.00%)  3/26 (11.54%) 
HYPOALBUMINEMIA  1  0/5 (0.00%)  1/8 (12.50%)  10/26 (38.46%) 
HYPOCALCEMIA  1  0/5 (0.00%)  1/8 (12.50%)  9/26 (34.62%) 
HYPOGLYCEMIA  1  0/5 (0.00%)  0/8 (0.00%)  4/26 (15.38%) 
HYPOKALEMIA  1  1/5 (20.00%)  1/8 (12.50%)  6/26 (23.08%) 
HYPOMAGNESEMIA  1  1/5 (20.00%)  0/8 (0.00%)  5/26 (19.23%) 
HYPONATREMIA  1  0/5 (0.00%)  0/8 (0.00%)  7/26 (26.92%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  1/5 (20.00%)  1/8 (12.50%)  2/26 (7.69%) 
BACK PAIN  1  1/5 (20.00%)  1/8 (12.50%)  2/26 (7.69%) 
MYALGIA  1  3/5 (60.00%)  3/8 (37.50%)  4/26 (15.38%) 
PAIN IN EXTREMITY  1  0/5 (0.00%)  0/8 (0.00%)  9/26 (34.62%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
BENIGN PROSTATE HYPERPLASIA  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Nervous system disorders       
DIZZINESS  1  1/5 (20.00%)  1/8 (12.50%)  6/26 (23.08%) 
DYSGEUSIA  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
HEADACHE  1  1/5 (20.00%)  1/8 (12.50%)  4/26 (15.38%) 
INSOMNIA  1  1/5 (20.00%)  3/8 (37.50%)  6/26 (23.08%) 
INVOLUNTARY MOVEMENTS  1  0/5 (0.00%)  2/8 (25.00%)  1/26 (3.85%) 
NEURALGIA  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
PERIPHERAL NEUROPATHY  1  5/5 (100.00%)  5/8 (62.50%)  10/26 (38.46%) 
SOMNOLENCE  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
SYNCOPE  1  0/5 (0.00%)  1/8 (12.50%)  1/26 (3.85%) 
TASTE ALTERATION  1  2/5 (40.00%)  3/8 (37.50%)  3/26 (11.54%) 
TREMOR  1  0/5 (0.00%)  0/8 (0.00%)  3/26 (11.54%) 
Psychiatric disorders       
ANXIETY  1  2/5 (40.00%)  2/8 (25.00%)  1/26 (3.85%) 
DEPRESSION  1  1/5 (20.00%)  2/8 (25.00%)  2/26 (7.69%) 
MOOD ALTERATION  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
Renal and urinary disorders       
PROTEINURIA  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
RENAL FAILURE  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
URINARY RETENTION  1  1/5 (20.00%)  0/8 (0.00%)  0/26 (0.00%) 
URINARY TRACT INFECTION  1  0/5 (0.00%)  1/8 (12.50%)  1/26 (3.85%) 
URINARY TRACT PAIN  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
URINE DISCOLORATION  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
ALLERGIC RHINITIS  1  1/5 (20.00%)  0/8 (0.00%)  3/26 (11.54%) 
CHEST CONGESTION  1  0/5 (0.00%)  1/8 (12.50%)  2/26 (7.69%) 
COUGH  1  1/5 (20.00%)  2/8 (25.00%)  8/26 (30.77%) 
DYSPNEA  1  1/5 (20.00%)  2/8 (25.00%)  7/26 (26.92%) 
NASAL CONGESTION  1  1/5 (20.00%)  0/8 (0.00%)  2/26 (7.69%) 
NASAL DRAINAGE  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
PLEURAL EFFUSION  1  0/5 (0.00%)  1/8 (12.50%)  2/26 (7.69%) 
RHINITIS  1  1/5 (20.00%)  0/8 (0.00%)  2/26 (7.69%) 
Skin and subcutaneous tissue disorders       
DESQUAMATION  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
DRY SKIN  1  0/5 (0.00%)  0/8 (0.00%)  2/26 (7.69%) 
ERYTHEMA  1  1/5 (20.00%)  0/8 (0.00%)  5/26 (19.23%) 
HYPERHIDROSIS  1  0/5 (0.00%)  0/8 (0.00%)  5/26 (19.23%) 
PAIN OF SKIN  1  0/5 (0.00%)  1/8 (12.50%)  0/26 (0.00%) 
PRURITUS  1  1/5 (20.00%)  4/8 (50.00%)  7/26 (26.92%) 
RASH  1  3/5 (60.00%)  5/8 (62.50%)  19/26 (73.08%) 
Vascular disorders       
HYPERTENSION  1  1/5 (20.00%)  1/8 (12.50%)  3/26 (11.54%) 
HYPOTENSION  1  1/5 (20.00%)  3/8 (37.50%)  3/26 (11.54%) 
THROMBOEMBOLIC EVENT  1  0/5 (0.00%)  1/8 (12.50%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
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Name/Title: Ian Flinn, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
Publications:
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Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00633594     History of Changes
Other Study ID Numbers: SCRI LYM 58
First Submitted: March 4, 2008
First Posted: March 12, 2008
Results First Submitted: August 19, 2016
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017