Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vacc-4x + Lenalidomide vs. Vacc-4x +Placebo in HIV-1-infected Subjects on Antiretroviral Therapy (ART) (IMID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01704781
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : March 8, 2017
Last Update Posted : March 8, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Bionor Immuno AS

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition HIV-1 Infection
Interventions Drug: Lenalidomide
Drug: Lenalidomide placebo
Drug: Vacc-4X
Drug: rhuGM-CSF
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A: Lenalidomide 5 mg Part A: Lenalidomide 10 mg Part A: Lenalidopmide 25 mg Part B: Lenalidomide Part B: Lenalidomide Placebo
Hide Arm/Group Description Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.

Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.

Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Period Title: Overall Study
Started 3 3 6 12 12
Completed 3 3 6 12 12
Not Completed 0 0 0 0 0
Arm/Group Title Part A: Lenalidomide 5 mg Part A: Lenalidomide 10 mg Part A: Lenalidopmide 25 mg Part B: Lenalidomide Part B: Lenalidomide Placebo Total
Hide Arm/Group Description Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.

Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.

Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Total of all reporting groups
Overall Number of Baseline Participants 3 3 6 12 12 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 6 participants 12 participants 12 participants 36 participants
43.7  (4.16) 35.7  (3.06) 46.2  (5.42) 44.4  (7.97) 41.5  (8.04) 42.9  (7.34)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 12 participants 12 participants 36 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
3
 100.0%
6
 100.0%
12
 100.0%
12
 100.0%
36
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 12 participants 12 participants 36 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
3
 100.0%
6
 100.0%
12
 100.0%
12
 100.0%
36
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 6 participants 12 participants 12 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
   8.3%
2
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.8%
White
3
 100.0%
1
  33.3%
6
 100.0%
12
 100.0%
11
  91.7%
33
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 3 participants 3 participants 6 participants 12 participants 12 participants 36 participants
23.7  (2.32) 27.9  (7.65) 24.4  (1.75) 23.6  (3.85) 23.5  (3.44) 24.1  (3.74)
1.Primary Outcome
Title Part A: To Establish Highest Tolerated Dose of Lenalidomide, Dose-Limiting Toxicity
Hide Description Number of participants in each of the three groups that experienced any dose-limiting toxicity.
Time Frame 31 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set was used.
Arm/Group Title Part A: Lenalidomide 5 mg Part A: Lenalidomide 10 mg Part A: Lenalidopmide 25 mg
Hide Arm/Group Description:
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
Overall Number of Participants Analyzed 3 3 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Part A: To Establish Highest Tolerated Dose of Lenalidomide, CD4 Counts Over Time
Hide Description [Not Specified]
Time Frame 31 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set was used.
Arm/Group Title Part A: Lenalidomide 5 mg Part A: Lenalidomide 10 mg Part A: Lenalidopmide 25 mg
Hide Arm/Group Description:
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
Overall Number of Participants Analyzed 3 3 6
Mean (Standard Deviation)
Unit of Measure: 10^6 cells/mL
Baseline 437.3  (38.30) 436.3  (60.05) 454.2  (86.59)
Week 1 393.0  (167.56) 317.0  (18.52) 342.2  (27.13)
Week 4 442.0  (121.77) 399.3  (15.95) 450.7  (147.02)
Week 5 432.7  (242.47) 449.0  (71.04) 452.3  (66.28)
3.Primary Outcome
Title Part B: Change in CD4 Count
Hide Description Change in CD4 count from baseline to Week 26.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed for both the Intent To Treat (ITT) and Per Protocol (PP) analysis set.
Arm/Group Title Part B: Lenalidomide Part B: Lenalidomide Placebo
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.

Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.

Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: 10^6 cells/L
ITT Number Analyzed 12 participants 12 participants
90.9  (98.79) 42.2  (81.40)
PP Number Analyzed 10 participants 11 participants
106.3  (101.00) 49.1  (81.58)
4.Secondary Outcome
Title Part B: Change in CD8 Count
Hide Description Change in CD8 count from baseline to week 26.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Not all patients had quantifiable blood samples/counts at all time points
Arm/Group Title Part B: Lenalidomide Part B: Lenalidomide Placebo
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.

Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.

Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: 10^6 cells/L
Baseline Number Analyzed 12 participants 12 participants
734.2  (473.14) 655.3  (325.19)
Week 1 Number Analyzed 11 participants 10 participants
653.8  (382.16) 784.5  (372.96)
Week 4 Number Analyzed 12 participants 11 participants
744.9  (485.49) 794.5  (452.91)
Week 12 Number Analyzed 12 participants 12 participants
823.0  (548.84) 760.3  (432.79)
Week 13 Number Analyzed 12 participants 11 participants
811.2  (557.52) 663.6  (393.95)
5.Secondary Outcome
Title Part B: Evaluate the Effect on HIV Viral Load
Hide Description Results BLQ (<20 HIV copies/mL) have been replaced with BLQ/2 = 10 HIV copies/mL while ‘not detected’ results have been replaced with 0 HIV copies/mL.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set
Arm/Group Title Part B: Lenalidomide Part B: Lenalidomide Placebo
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.

Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.

Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: Copies/mL
Baseline Number Analyzed 12 participants 12 participants
0.8  (2.89) 2.5  (4.52)
Week 1 Number Analyzed 12 participants 12 participants
5.1  (9.30) 0.0  (0.00)
Week 4 Number Analyzed 12 participants 11 participants
6.4  (8.17) 0.9  (3.02)
Week 12 Number Analyzed 12 participants 12 participants
5.5  (11.29) 4.3  (6.90)
Week 13 Number Analyzed 12 participants 12 participants
7.4  (19.77) 1.7  (3.89)
Week 21 Number Analyzed 12 participants 12 participants
1.7  (3.89) 4.2  (5.15)
Week 26 Number Analyzed 12 participants 12 participants
3.5  (6.99) 2.5  (4.52)
6.Secondary Outcome
Title Part B: Incidents of Delayed-type Hypersensitivity
Hide Description Delayed-type hypersensitivity measured by induration and erythema.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The IIT population was used for this outcome measure. Data for one patient was not reported at week 26.
Arm/Group Title Part B: Lenalidomide Part B: Lenalidomide Placebo
Hide Arm/Group Description:

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.

Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.

Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1, Induration Number Analyzed 12 participants 12 participants
0
   0.0%
0
   0.0%
Week 1, Erythema Number Analyzed 12 participants 12 participants
0
   0.0%
1
   8.3%
Week 26, Induration Number Analyzed 11 participants 11 participants
5
  45.5%
2
  18.2%
Week 26, Erythema Number Analyzed 11 participants 11 participants
6
  54.5%
6
  54.5%
7.Secondary Outcome
Title Part A and B: Safety and Tolerability
Hide Description [Not Specified]
Time Frame Part A: 31 days and Part B: 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part A: Lenalidomide 5 mg Part A: Lenalidomide 10 mg Part A: Lenalidopmide 25 mg Part B: Lenalidomide Part B: Lenalidomide Placebo
Hide Arm/Group Description:
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.

Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.

Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Overall Number of Participants Analyzed 3 3 6 12 12
Measure Type: Number
Unit of Measure: participants
With any TEAE 3 2 6 10 9
With TESAE 0 0 0 1 0
With any AE resultiung in withdrawal 0 0 0 0 0
Deaths 0 0 0 0 0
Time Frame Adverse events were collected from the time of signing informed consent and until last visit; 31 days in Part A and 26 weeks in Part B. In addition, a 5-year survival follow-up period during which telephone contact from site for all subjects who discontinue treatment at any time will be conducted every 4 months for the first two years and every 6 months thereafter for a minimum of 5 years post-inclusion for survival, cause(s) of death, disease progression and post-treatment therapy(ies).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part A: Lenalidomide 5 mg Part A: Lenalidomide 10 mg Part A: Lenalidopmide 25 mg Part B: Lenalidomide Part B: Lenalidomide Placebo
Hide Arm/Group Description Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.

Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.

Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.

Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.

rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant

All-Cause Mortality
Part A: Lenalidomide 5 mg Part A: Lenalidomide 10 mg Part A: Lenalidopmide 25 mg Part B: Lenalidomide Part B: Lenalidomide Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part A: Lenalidomide 5 mg Part A: Lenalidomide 10 mg Part A: Lenalidopmide 25 mg Part B: Lenalidomide Part B: Lenalidomide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/3 (0.00%)      0/6 (0.00%)      1/12 (8.33%)      0/12 (0.00%)    
Infections and infestations           
Abscess left upper arm  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, medDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A: Lenalidomide 5 mg Part A: Lenalidomide 10 mg Part A: Lenalidopmide 25 mg Part B: Lenalidomide Part B: Lenalidomide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      2/3 (66.67%)      6/6 (100.00%)      10/12 (83.33%)      9/12 (75.00%)    
Blood and lymphatic system disorders           
Lymphadenopathy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  2
Ear and labyrinth disorders           
Tinnitus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Endocrine disorders           
Hypogonadism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Eye disorders           
Conjunctivitis allergic  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Gastrointestinal disorders           
Diarrhoea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1
Nausea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  2
Abdominnal pain upper  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Abdominal tenderness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Colitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Dry mouth  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
General disorders           
Fatigue  1  1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 2/12 (16.67%)  2 4/12 (33.33%)  6
Injection site erythema  1  2/3 (66.67%)  4 1/3 (33.33%)  4 2/6 (33.33%)  2 4/12 (33.33%)  6 2/12 (16.67%)  3
Injection site pruritus  1  2/3 (66.67%)  4 0/3 (0.00%)  0 1/6 (16.67%)  1 3/12 (25.00%)  4 2/12 (16.67%)  2
Injection site swelling  1  1/3 (33.33%)  3 1/3 (33.33%)  1 0/6 (0.00%)  0 2/12 (16.67%)  4 0/12 (0.00%)  0
Injection site induration  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Injection site pain  1  1/3 (33.33%)  2 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 2/12 (16.67%)  2
Injection site warmth  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Application site pruritus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 2/12 (16.67%)  2 1/12 (8.33%)  1
Application site erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Influenza like illness  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  3 2/12 (16.67%)  6 1/12 (8.33%)  1
Chest pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Asthenia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  2 0/12 (0.00%)  0
Swelling  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Hepatobiliary disorders           
Hypertransaminasaemia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Immune system disorders           
Hypersensitivity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Seasonal allergy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Infections and infestations           
Nasopharyngitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/12 (16.67%)  2 0/12 (0.00%)  0
Rhinitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 1/12 (8.33%)  1
Abscess limb  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Bronchitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Chlamydial infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Folliculitis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Gastroenteritis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Herpes zoster  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Tooth infection  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Sunisitis  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Injury, poisoning and procedural complications           
Injection related reaction  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 2/12 (16.67%)  3
Groin pain  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Pain in extremity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Nervous system disorders           
Autonomic nervous system imbalance  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Cerebral atrophy  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Facial paresis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Grand mal convultion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Headache  1  1/3 (33.33%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0
Paraesthesia  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0 1/12 (8.33%)  1
Psychiatric disorders           
Aggression  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Listless  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 0/12 (0.00%)  0
Skin and subcutaneous tissue disorders           
Erythema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/12 (25.00%)  3 0/12 (0.00%)  0
Pruritus  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  3 3/12 (25.00%)  5 0/12 (0.00%)  0
Pruritus generalized  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  2 0/12 (0.00%)  0
Angioedema  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/12 (8.33%)  1 0/12 (0.00%)  0
Rash  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 3/12 (25.00%)  6 0/12 (0.00%)  0
Actinic keratosis  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Scab  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Skin lesion  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Vascular disorders           
Flushing  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Hypertension  1  0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, medDRA 15.0
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 (or designee) will prepare a final report on the study. The Investigator may not publish or present any information on this study without the express written approval of the Sponsor. Additionally, the Sponsor, may, for any reason, withhold approval for publication or presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maja Sommerfelt
Organization: Bionor Pharma ASA
Phone: +4723010960
EMail: ms@bionorpharma.com
Layout table for additonal information
Responsible Party: Bionor Immuno AS
ClinicalTrials.gov Identifier: NCT01704781     History of Changes
Other Study ID Numbers: CT-BI Vacc-4x/IMiD-2010/1
First Submitted: September 11, 2012
First Posted: October 11, 2012
Results First Submitted: January 16, 2017
Results First Posted: March 8, 2017
Last Update Posted: March 8, 2017