ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy

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: NCT01094548
Recruitment Status : Completed
First Posted : March 29, 2010
Results First Posted : February 22, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Biological: Tecemotide (L-BLP25)
Drug: Single low dose cyclophosphamide
Drug: Multiple low dose cyclophosphamide
Enrollment 34
Recruitment Details First/last participant (informed consent): 21 January 2008/11 January 2010. Last participant completed: 07 March 2012; Clinical data cut-off date: 07 March 2012.
Pre-assignment Details A total of 36 participants were screened for eligibility; 2 were excluded (mainly non-fulfillment of inclusion or exclusion) and 34 participants were enrolled and randomized.
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Hide Arm/Group Description

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

Period Title: Overall Study
Started 17 17
Completed 17 17
Not Completed 0 0
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide Total
Hide Arm/Group Description

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
62.5  (7.26) 63.9  (9.36) 63.2  (8.28)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
9
  52.9%
10
  58.8%
19
  55.9%
Male
8
  47.1%
7
  41.2%
15
  44.1%
1.Primary Outcome
Title Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response
Hide Description The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon [IFN] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell [PBMC]) with ratio to background >=2, and ratio of background-corrected value to baseline >=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t – Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS[t]=1), upon fulfilling the following criteria: Yt =>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t–1SEM vax,t > AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).
Time Frame From the date of randomization up to Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Hide Arm/Group Description:

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration in Weeks 1 and 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

Overall Number of Participants Analyzed 17 15
Measure Type: Number
Unit of Measure: participants
8 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide, Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response
Hide Description Baseline immune response towards MUC1 was defined as an immune response towards BP25, MUC-A2 or MUC-A11 peptide stimulation which was present in at least one of the two baseline assessments; the specific immune responses at baseline were based on the averaged baseline values across the two baseline visits. Initial increase of MUC1-specific immune response was defined as an increase of MUC1-specific immune response during the primary treatment period (up to Week 9).
Time Frame Baseline and Week 9
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Hide Arm/Group Description:

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg/m^2) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

Overall Number of Participants Analyzed 17 15
Measure Type: Number
Unit of Measure: participants
Baseline immune response 10 7
MUC1 specific immune response at Week 9 8 7
3.Secondary Outcome
Title Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type
Hide Description Relationship between immune response with HLA subtypes was determined by analyzing the number of participants with overall induced immune response grouped by the presence versus absence of the given HLA type.
Time Frame From the date of randomization up to Week 104
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least 1 complete set of baseline, Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay. “n” signifies number of participants evaluable for the particular HLA type, respectively.
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Hide Arm/Group Description:

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

Overall Number of Participants Analyzed 17 15
Measure Type: Number
Unit of Measure: participants
HLA A01 (n=3, 7) 2 3
HLA A01 not present (n=14, 8) 6 4
HLA A02 present (n=10, 10) 5 4
HLA A02 not present (n=7, 5) 3 3
HLA A03 present (n=4, 3) 3 0
HLA A03 not present (n=13, 12) 5 7
HLA A24 present (n=7, 1) 3 1
HLA A24 not present (n=10, 14) 5 6
HLA A68 present (n=2, 3) 0 2
HLA A68 not present (n=15, 12) 8 5
HLA B07 present (n=6, 5) 3 2
HLA B07 not present (n=11, 10) 5 5
HLA B08 present (n=3, 6) 2 3
HLA B08 not present (n=14, 9) 6 4
HLA B15 present (n=4, 1) 1 0
HLA B15 not present (n=13, 14) 7 7
HLA B27 present (n=3, 2) 1 1
HLA B27 not present (n=14, 13) 7 6
HLA B35 present (n=2, 4) 2 2
HLA B35 not present (n=15, 11) 6 5
HLA B44 present (n=4, 2) 2 2
HLA B44 not present (n=13, 13) 6 5
HLA C01 present (n=1, 4) 1 3
HLA C01 not present (n=16, 11) 7 4
HLA C02 present (n=3, 1) 1 0
HLA C02 not present (n=14, 14) 7 7
HLA C03 present (n=9, 2) 4 0
HLA C03 not present (n=8, 13) 4 7
HLA C04 present (n=1, 3) 1 2
HLA C04 not present (n=16, 12) 7 5
HLA C07 present (n=12, 10) 6 4
HLA C07 not present (n=5, 5) 2 3
HLA DQB02 present (n=2, 6) 0 3
HLA DQB02 not present (n=15, 9) 8 4
HLA DQB03 present (n=11, 9) 6 5
HLA DQB03 not present (n=6, 6) 2 2
HLA DQB05 present (n=6, 2) 2 0
HLA DQB05 not present (n=11, 13) 6 7
HLA DQB06 present (n=7, 5) 4 3
HLA DQB06 not present (n=10, 10) 4 4
HLA DRB01 present (n=3, 1) 1 0
HLA DRB01 not present (n=14, 14) 7 7
HLA DRB03 present (n=2, 6) 0 3
HLA DRB03 not present (n=15, 9) 8 4
HLA DRB04 present (n=11, 6) 6 3
HLA DRB04 not present (n=6, 9) 2 4
HLA DRB11 present (n=2, 5) 1 3
HLA DRB11 not present (n=15, 10) 7 4
HLA DRB13 present (n=5, 2) 3 1
HLA DRB13 not present (n=12, 13) 5 6
HLA DRB15 present (n=5, 3) 3 2
HLA DRB15 not present (n=12, 12) 5 5
4.Secondary Outcome
Title Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR]
Hide Description OCR (CR, or PR, or MR or NC or PD or NE) was defined per Blade Criteria. OCR rate (CR, or PR, or MR) was defined as the number of participants having experienced at least once a CR, PR, or MR, divided by the number of all participants. CR: negative immunofixation on serum and urine monoclonal paraprotein (M-protein), disappearance of any soft tissue plasmacytomas (STP), <=5% plasma cells in bone marrow (BM); PR: >=50% reduction in serum M-protein, plasma cells in BM, size of STP; >=90% reduction of urinary M-protein in 24 hours, no increase in size/number of the lytic bone lesions (LBL). MR: 25%-49% reduction in serum M-protein, plasma cells in BM aspirate in non-secretory myeloma participants, size of STP; 50%-89% reduction in 24 h urinary light chain reaction (LCR), and no increase in size/number of LBL. PD: >25% increase in the serum M-protein level, 24 hour urinary LCR. Increase in size of existing BL or STP, development of new BL or STP, or development of hypercalcemia
Time Frame From the date of randomization up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Hide Arm/Group Description:

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

Overall Number of Participants Analyzed 17 15
Measure Type: Number
Unit of Measure: Percentage of participants
CR+PR+MR 0.0 0.0
CR 0.0 0.0
PR 0.0 0.0
MR 0.0 0.0
5.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Progression was defined as follows per Blade criteria: The disease was considered to be progressive if it met 1 or more of the following: >25% increase in the level of serum monoclonal paraprotein (M-protein);>25% increase in the 24 h urinary light chain excretion; >25% increase in plasma cells in the bone marrow- definite increase in the size of existing bone lesions or soft tissues plasmacytomas (STP); Development of new bone lesions or STP, or development of hypercalcemia. TTP was defined as time from randomization to disease progression. Participants without events were censored on the date of last tumor assessment. Participants without PD at time of treatment discontinuation were censored at the date of discontinuation. Participants without PD at the time of the analysis but still on treatment were censored at the date of the latest available multiple myeloma status assessment. Participants dying from causes other than PD were treated as censored observations at time of death.
Time Frame From the date of randomization up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Hide Arm/Group Description:

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

Overall Number of Participants Analyzed 17 15
Median (95% Confidence Interval)
Unit of Measure: months
15.2
(14.5 to 20.8)
38.9 [1] 
(17.3 to NA)
[1]
The number of events were not sufficient to calculate the upper limit of the confidence interval.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide, Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0940
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.431
Confidence Interval (2-Sided) 95%
0.157 to 1.185
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to Anti-tumor Therapy
Hide Description Time from date of randomization to the date of first anti-tumor therapy since end of study treatment. In case a concomitant or concurrent procedure was identified as anti-tumor therapy during the medical review process, the start date of that anti-tumor therapy was used instead. Participants in the survival follow-up phase without subsequent anti-tumor therapy at the time of the analysis were censored at the latest available follow-up date. Participants without anti-tumor therapy and still on treatment at the time of analysis were censored at the data cut-off date if any trial treatment administration was recorded after the data cut-off date. In case no such record exists, the subject was censored at the last available administration date prior or equal to the data cut-off date. Participants dying before start of subsequent anti-tumor therapy were treated as censored observations at time of death.
Time Frame From the date of randomization up to Month 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Immunological diagnostic analysis set was defined as the subset of safety analysis set consisting of all the participants with at least one complete set of baseline (baseline/cyclophosphamide infusion visit or both), Week 5, and Week 9 data of either ELISPOT, proliferation assay or cytokine assay.
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Hide Arm/Group Description:

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

Overall Number of Participants Analyzed 17 15
Median (95% Confidence Interval)
Unit of Measure: months
24.7 [1] 
(14.8 to NA)
36.7 [1] 
(23.3 to NA)
[1]
The number of events were not sufficient to calculate the upper limit of the confidence interval.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide, Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3919
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.666
Confidence Interval (2-Sided) 95%
0.261 to 1.698
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs)
Hide Description TEAEs occurred between the first dose of study drug administration and up to 42 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state. A Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.Grade 3 and 4 TEAES as per National Cancer Institute Common Terminology Criteria for Adverse Experience version 3 (NCI-CTCAE v3.0) were presented. Grade 3 refers to severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care and Activity of daily living (ADL).Grade 4 refers to Life-threatening consequences; where urgent intervention indicated. Injection site reactions, term used per NCI-CTCAE, were also presented.
Time Frame From the first dose of study drug administration up to 42 days after the last dose of study drug administration or clinical data cut-off date (07 March 2012)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Hide Arm/Group Description:

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

Overall Number of Participants Analyzed 17 17
Measure Type: Number
Unit of Measure: participants
TEAEs 17 17
Serious TEAEs 6 5
NCI-CTC Grade 3 and 4 TEAEs 5 8
TEAEs leading to discontinuation of treatment 1 2
ISRs 8 11
Time Frame From the first dose of study drug and up to 42 days after the last dose of study drug or clinical data cut-off date (07 March 2012)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Hide Arm/Group Description

Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.

Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years.

All-Cause Mortality
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Affected / at Risk (%) Affected / at Risk (%)
Total   6/17 (35.29%)   5/17 (29.41%) 
Cardiac disorders     
Atrial fibrillation * 1  0/17 (0.00%)  2/17 (11.76%) 
Eye disorders     
Retinal detachment * 1  1/17 (5.88%)  0/17 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/17 (5.88%)  0/17 (0.00%) 
General disorders     
Non-cardiac chest pain * 1  1/17 (5.88%)  0/17 (0.00%) 
Pyrexia * 1  0/17 (0.00%)  1/17 (5.88%) 
Hepatobiliary disorders     
Cholecystitis * 1  0/17 (0.00%)  1/17 (5.88%) 
Infections and infestations     
Arthritis bacterial * 1  0/17 (0.00%)  1/17 (5.88%) 
Pneumonia * 1  1/17 (5.88%)  0/17 (0.00%) 
Sepsis * 1  0/17 (0.00%)  2/17 (11.76%) 
Wound infection * 1  0/17 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders     
Hypercalcaemia * 1  1/17 (5.88%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/17 (0.00%)  1/17 (5.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer * 1  1/17 (5.88%)  0/17 (0.00%) 
Colon cancer * 1  0/17 (0.00%)  1/17 (5.88%) 
Nervous system disorders     
Cerebral haemorrhage * 1  0/17 (0.00%)  1/17 (5.88%) 
Encephalitis * 1  0/17 (0.00%)  1/17 (5.88%) 
Loss of consciousness * 1  0/17 (0.00%)  1/17 (5.88%) 
Status epilepticus * 1  0/17 (0.00%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  0/17 (0.00%)  1/17 (5.88%) 
Vascular disorders     
Aortic aneurysm * 1  1/17 (5.88%)  0/17 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide
Affected / at Risk (%) Affected / at Risk (%)
Total   17/17 (100.00%)   17/17 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  0/17 (0.00%)  3/17 (17.65%) 
Iron deficiency anaemia * 1  1/17 (5.88%)  0/17 (0.00%) 
Cardiac disorders     
Tachycardia * 1  0/17 (0.00%)  1/17 (5.88%) 
Ear and labyrinth disorders     
Sudden hearing loss * 1  1/17 (5.88%)  0/17 (0.00%) 
Vertigo * 1  1/17 (5.88%)  3/17 (17.65%) 
Eye disorders     
Dacryostenosis acquired * 1  1/17 (5.88%)  0/17 (0.00%) 
Dry eye * 1  1/17 (5.88%)  0/17 (0.00%) 
Retinal detachment * 1  1/17 (5.88%)  0/17 (0.00%) 
Vision blurred * 1  0/17 (0.00%)  1/17 (5.88%) 
Visual impairment * 1  2/17 (11.76%)  0/17 (0.00%) 
Ectropion * 1  0/17 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  2/17 (11.76%)  1/17 (5.88%) 
Constipation * 1  2/17 (11.76%)  8/17 (47.06%) 
Diarrhoea * 1  2/17 (11.76%)  4/17 (23.53%) 
Dry mouth * 1  0/17 (0.00%)  1/17 (5.88%) 
Dysphagia * 1  0/17 (0.00%)  1/17 (5.88%) 
Gastritis * 1  0/17 (0.00%)  1/17 (5.88%) 
Gingivitis * 1  1/17 (5.88%)  0/17 (0.00%) 
Nausea * 1  7/17 (41.18%)  12/17 (70.59%) 
Paraesthesia oral * 1  1/17 (5.88%)  0/17 (0.00%) 
Proctalgia * 1  0/17 (0.00%)  1/17 (5.88%) 
Tongue blistering * 1  0/17 (0.00%)  1/17 (5.88%) 
Toothache * 1  0/17 (0.00%)  3/17 (17.65%) 
Vomiting * 1  1/17 (5.88%)  1/17 (5.88%) 
General disorders     
Chest discomfort * 1  1/17 (5.88%)  0/17 (0.00%) 
Chest pain * 1  3/17 (17.65%)  4/17 (23.53%) 
Chills * 1  0/17 (0.00%)  1/17 (5.88%) 
Fatigue * 1  9/17 (52.94%)  11/17 (64.71%) 
Influenza like illness * 1  0/17 (0.00%)  2/17 (11.76%) 
Injection site erythema * 1  3/17 (17.65%)  4/17 (23.53%) 
Injection site nodule * 1  5/17 (29.41%)  7/17 (41.18%) 
Injection site pruritus * 1  3/17 (17.65%)  0/17 (0.00%) 
Injection site rash * 1  1/17 (5.88%)  0/17 (0.00%) 
Injection site ulcer * 1  1/17 (5.88%)  0/17 (0.00%) 
Injection site warmth * 1  0/17 (0.00%)  1/17 (5.88%) 
Malaise * 1  0/17 (0.00%)  2/17 (11.76%) 
Non-cardiac chest pain * 1  1/17 (5.88%)  0/17 (0.00%) 
Oedema peripheral * 1  0/17 (0.00%)  1/17 (5.88%) 
Pain * 1  1/17 (5.88%)  0/17 (0.00%) 
Pyrexia * 1  3/17 (17.65%)  4/17 (23.53%) 
Injection site haematoma * 1  1/17 (5.88%)  4/17 (23.53%) 
Immune system disorders     
Allergy to arthropod bite * 1  2/17 (11.76%)  0/17 (0.00%) 
Seasonal allergy * 1  1/17 (5.88%)  0/17 (0.00%) 
Infections and infestations     
Borrelia infection * 1  0/17 (0.00%)  1/17 (5.88%) 
Bronchopneumonia * 1  1/17 (5.88%)  0/17 (0.00%) 
Eczema infected * 1  0/17 (0.00%)  1/17 (5.88%) 
Erysipelas * 1  1/17 (5.88%)  0/17 (0.00%) 
Eye infection * 1  1/17 (5.88%)  1/17 (5.88%) 
Gastric infection * 1  1/17 (5.88%)  0/17 (0.00%) 
Gastroenteritis * 1  0/17 (0.00%)  2/17 (11.76%) 
Gastrointestinal infection * 1  1/17 (5.88%)  0/17 (0.00%) 
Herpes zoster * 1  0/17 (0.00%)  1/17 (5.88%) 
Herpes zoster ophthalmic * 1  1/17 (5.88%)  0/17 (0.00%) 
Influenza * 1  0/17 (0.00%)  1/17 (5.88%) 
Injection site abscess * 1  1/17 (5.88%)  0/17 (0.00%) 
Injection site infection * 1  1/17 (5.88%)  0/17 (0.00%) 
Nasopharyngitis * 1  7/17 (41.18%)  7/17 (41.18%) 
Otitis externa * 1  2/17 (11.76%)  0/17 (0.00%) 
Pharyngitis * 1  0/17 (0.00%)  1/17 (5.88%) 
Pneumonia * 1  1/17 (5.88%)  1/17 (5.88%) 
Respiratory moniliasis * 1  0/17 (0.00%)  1/17 (5.88%) 
Upper respiratory tract infection * 1  7/17 (41.18%)  10/17 (58.82%) 
Urinary tract infection * 1  2/17 (11.76%)  0/17 (0.00%) 
Viral infection * 1  0/17 (0.00%)  1/17 (5.88%) 
Skin bacterial infection * 1  0/17 (0.00%)  1/17 (5.88%) 
Localised infection * 1  0/17 (0.00%)  1/17 (5.88%) 
Injury, poisoning and procedural complications     
Arthropod bite * 1  1/17 (5.88%)  0/17 (0.00%) 
Back injury * 1  1/17 (5.88%)  0/17 (0.00%) 
Contusion * 1  0/17 (0.00%)  1/17 (5.88%) 
Fall * 1  2/17 (11.76%)  0/17 (0.00%) 
Foot fracture * 1  0/17 (0.00%)  1/17 (5.88%) 
Skin laceration * 1  1/17 (5.88%)  0/17 (0.00%) 
Sternal fracture * 1  0/17 (0.00%)  1/17 (5.88%) 
Thermal burn * 1  1/17 (5.88%)  0/17 (0.00%) 
Wound * 1  1/17 (5.88%)  1/17 (5.88%) 
Wrong drug administered * 1  0/17 (0.00%)  1/17 (5.88%) 
Eye injury * 1  0/17 (0.00%)  1/17 (5.88%) 
Post-traumatic pain * 1  1/17 (5.88%)  0/17 (0.00%) 
Traumatic haematoma * 1  1/17 (5.88%)  0/17 (0.00%) 
Investigations     
C-reactive protein increased * 1  0/17 (0.00%)  1/17 (5.88%) 
Haemoglobin decreased * 1  0/17 (0.00%)  1/17 (5.88%) 
Metabolism and nutrition disorders     
Appetite disorder * 1  1/17 (5.88%)  0/17 (0.00%) 
Hypercalcaemia * 1  0/17 (0.00%)  1/17 (5.88%) 
Hyperkalaemia * 1  1/17 (5.88%)  0/17 (0.00%) 
Hyperlipidaemia * 1  0/17 (0.00%)  1/17 (5.88%) 
Hypoalbuminaemia * 1  0/17 (0.00%)  1/17 (5.88%) 
Vitamin B12 deficiency * 1  1/17 (5.88%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  4/17 (23.53%)  3/17 (17.65%) 
Back pain * 1  10/17 (58.82%)  6/17 (35.29%) 
Bone pain * 1  1/17 (5.88%)  0/17 (0.00%) 
Foot deformity * 1  1/17 (5.88%)  0/17 (0.00%) 
Joint swelling * 1  1/17 (5.88%)  0/17 (0.00%) 
Muscle spasms * 1  0/17 (0.00%)  1/17 (5.88%) 
Muscular weakness * 1  0/17 (0.00%)  1/17 (5.88%) 
Musculoskeletal chest pain * 1  2/17 (11.76%)  1/17 (5.88%) 
Musculoskeletal pain * 1  1/17 (5.88%)  0/17 (0.00%) 
Myalgia * 1  3/17 (17.65%)  2/17 (11.76%) 
Neck pain * 1  1/17 (5.88%)  2/17 (11.76%) 
Pain in extremity * 1  3/17 (17.65%)  5/17 (29.41%) 
Sjogren’s syndrome * 1  0/17 (0.00%)  1/17 (5.88%) 
Spinal osteoarthritis * 1  0/17 (0.00%)  1/17 (5.88%) 
Joint hyperextension * 1  0/17 (0.00%)  1/17 (5.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  1/17 (5.88%)  0/17 (0.00%) 
Tumor invasion * 1  0/17 (0.00%)  1/17 (5.88%) 
Nervous system disorders     
Amnesia * 1  1/17 (5.88%)  0/17 (0.00%) 
Aphasia * 1  0/17 (0.00%)  1/17 (5.88%) 
Dizziness * 1  2/17 (11.76%)  1/17 (5.88%) 
Formication * 1  1/17 (5.88%)  0/17 (0.00%) 
Headache * 1  3/17 (17.65%)  3/17 (17.65%) 
Hypoaesthesia * 1  1/17 (5.88%)  1/17 (5.88%) 
Migraine with aura * 1  1/17 (5.88%)  0/17 (0.00%) 
Paraesthesia * 1  0/17 (0.00%)  1/17 (5.88%) 
Psychiatric disorders     
Agitation * 1  0/17 (0.00%)  1/17 (5.88%) 
Anxiety * 1  0/17 (0.00%)  2/17 (11.76%) 
Depression * 1  4/17 (23.53%)  2/17 (11.76%) 
Insomnia * 1  2/17 (11.76%)  3/17 (17.65%) 
Mood altered * 1  0/17 (0.00%)  1/17 (5.88%) 
Sleep disorder * 1  0/17 (0.00%)  1/17 (5.88%) 
Bipolar disorder * 1  0/17 (0.00%)  1/17 (5.88%) 
Renal and urinary disorders     
Albuminuria * 1  1/17 (5.88%)  0/17 (0.00%) 
Haematuria * 1  0/17 (0.00%)  1/17 (5.88%) 
Pollakiuria * 1  0/17 (0.00%)  1/17 (5.88%) 
Urinary retention * 1  0/17 (0.00%)  1/17 (5.88%) 
Reproductive system and breast disorders     
Breast mass * 1  1/17 (5.88%)  0/17 (0.00%) 
Erectile dysfunction * 1  1/17 (5.88%)  0/17 (0.00%) 
Pelvic pain * 1  1/17 (5.88%)  0/17 (0.00%) 
Prostatitis * 1  1/17 (5.88%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/17 (5.88%)  1/17 (5.88%) 
Cough * 1  5/17 (29.41%)  2/17 (11.76%) 
Dyspnoea * 1  0/17 (0.00%)  2/17 (11.76%) 
Epistaxis * 1  1/17 (5.88%)  1/17 (5.88%) 
Oropharyngeal pain * 1  2/17 (11.76%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  0/17 (0.00%)  3/17 (17.65%) 
Blood blister * 1  1/17 (5.88%)  0/17 (0.00%) 
Dermatitis allergic * 1  1/17 (5.88%)  0/17 (0.00%) 
Dry skin * 1  0/17 (0.00%)  1/17 (5.88%) 
Erythema * 1  0/17 (0.00%)  2/17 (11.76%) 
Pruritus * 1  0/17 (0.00%)  1/17 (5.88%) 
Rash * 1  3/17 (17.65%)  4/17 (23.53%) 
Skin nodule * 1  1/17 (5.88%)  2/17 (11.76%) 
Skin reaction * 1  0/17 (0.00%)  1/17 (5.88%) 
Urticaria * 1  0/17 (0.00%)  1/17 (5.88%) 
Increased tendency to bruise * 1  0/17 (0.00%)  1/17 (5.88%) 
Vascular disorders     
Deep vein thrombosis * 1  1/17 (5.88%)  0/17 (0.00%) 
Hypertension * 1  3/17 (17.65%)  4/17 (23.53%) 
Hypotension * 1  0/17 (0.00%)  1/17 (5.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
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.
Any publications of the results, either in part or in total (abstracts in journals or newspapers, oral presentations, etc.) by Investigators or their representatives will require pre-submission review by the Sponsor. The Sponsor is entitled to delay publication in order to obtain patent protection.
Results Point of Contact
Name/Title: Merck KGaA Communication Center
Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Publications:
Rossmann E, Österborg A, Löfvenberg E, et al. Randomized Phase II Study of BLP25 Liposome Vaccine (L-BLP25) in Patients with Multiple Myeloma. Am Soc Hematol. 53rd Annual Meeting, Dec 2011, Poster 2927.
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01094548     History of Changes
Other Study ID Numbers: EMR63325-008
First Submitted: March 24, 2010
First Posted: March 29, 2010
Results First Submitted: October 15, 2015
Results First Posted: February 22, 2016
Last Update Posted: February 22, 2016