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Tecemotide (L-BLP25) is believed to induce a Mucinous glycoprotein 1 (MUC1)-specific T-cell response after vaccination. The primary purpose of this study is to ascertain whether vaccination with tecemotide (L-BLP25) induces a MUC1-specific T-cell response in slowly progressive or chemotherapy naive multiple myeloma subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecemotide (L-BLP25) plus single low dose cyclophosphamide | Experimental |
| |
| Tecemotide (L-BLP25) plus multiple low dose cyclophosphamide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecemotide (L-BLP25) | Biological | After receiving single low dose of cyclophosphamide, subjects will receive 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 is documented. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response | 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). | From the date of randomization up to Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response | 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). |
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Inclusion Criteria:
Exclusion Criteria:
Pre-Therapies:
Medical Conditions:
Standard Safety:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact the Merck KGaA Communication Center | Darmstadt | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 25483677 | Derived | Rossmann E, Osterborg A, Lofvenberg E, Choudhury A, Forssmann U, von Heydebreck A, Schroder A, Mellstedt H. Mucin 1-specific active cancer immunotherapy with tecemotide (L-BLP25) in patients with multiple myeloma: an exploratory study. Hum Vaccin Immunother. 2014;10(11):3394-408. doi: 10.4161/hv.29918. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tecemotide (L-BLP25) | Biological | After receiving multiple low dose of cyclophosphamide, subjects will receive 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 is documented. |
|
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| Single low dose cyclophosphamide | Drug | An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment. |
|
| Multiple low dose cyclophosphamide | Drug | An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment plus an intravenous 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. |
|
| Baseline and Week 9 |
| Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type | 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. | From the date of randomization up to Week 104 |
| Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR] | 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 | From the date of randomization up to Month 48 |
| Time to Progression (TTP) | 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. | From the date of randomization up to Month 48 |
| Time to Anti-tumor Therapy | 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. | From the date of randomization up to Month 48 |
| 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) | 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. | 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) |
| FG001 | Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 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. |
| BG001 | Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response | 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). | 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. | Posted | Number | participants | From the date of randomization up to Week 104 |
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| Secondary | Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response | 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). | 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. | Posted | Number | participants | Baseline and Week 9 |
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| Secondary | Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type | 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. | 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. | Posted | Number | participants | From the date of randomization up to Week 104 |
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| Secondary | Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR] | 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 | 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. | Posted | Number | Percentage of participants | From the date of randomization up to Month 48 |
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| Secondary | Time to Progression (TTP) | 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. | 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. | Posted | Median | 95% Confidence Interval | months | From the date of randomization up to Month 48 |
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| Secondary | Time to Anti-tumor Therapy | 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. | 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. | Posted | Median | 95% Confidence Interval | months | From the date of randomization up to Month 48 |
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| Secondary | 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) | 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. | Safety analysis set included all the randomized participants who received at least 1 dose of trial treatment. | Posted | Number | participants | 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) |
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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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide | 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. | 6 | 17 | 17 | 17 | ||
| EG001 | Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 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. | 5 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dacryostenosis acquired | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tongue blistering | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection site ulcer | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Borrelia infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Eczema infected | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastric infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Herpes zoster ophthalmic | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection site infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Respiratory moniliasis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Wrong drug administered | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Appetite disorder | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Formication | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Albuminuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Ectropion | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Joint hyperextension | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Tumor invasion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Increased tendency to bruise | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C518273 | L-BLP25 |
| D012847 | Single Person |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
Not provided
Not provided
| Male |
|
| OG001 |
| Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide |
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. |
|
|
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.
|
|
| OG001 | Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 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. |
|
|
| OG001 | Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 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. |
|
|
|
| OG001 | Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 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. |
|
|
|
| OG001 | Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide | 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. |
|
|