Multiple Myeloma, Non-Small Cell Lung Cancer
Conditions
Keywords
Vaccine, Stimuvax, Tecemotide, L-BLP25, Non-Small Cell Lung Carcinoma, Multiple Myeloma
Brief summary
This is an open-label, common follow-up trial. Subjects who were enrolled in a Merck KGaA, EMD Serono or Merck Serono Japan sponsored trial with tecemotide (L-BLP25) were enrolled in this follow-up trial to continue their maintenance treatment with tecemotide (L-BLP25). Subjects were transferred once the feeder trial (EMR 63325-005 \[NCT00157209\], EMR 63325-006 \[NCT00157196\] and EMR 63325-008 \[NCT01094548\]) objectives were met. Subjects who received tecemotide (L-BLP25) in a feeder trial continued tecemotide (L-BLP25) treatment in this follow-up trial and have safety assessments performed as well as were observed for progressive disease (PD) and survival in 6- month intervals. Subjects who had not received tecemotide (L-BLP25) in feeder trials, or discontinued treatment were only observed for PD and survival in 6-month intervals and were not provided treatment with tecemotide (L-BLP25).
Interventions
BIOLOGICALTecemotide
Subjects who received tecemotide (L-BLP25) for the treatment of non-small cell lung cancer (NSCLC) or multiple myeloma in a feeder trial will continue to be treated with tecemotide (L-BLP25) and have safety assessments performed until the discontinuation criteria in the respective feeder trial protocol are met.
OTHERNo intervention
Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25), will only be observed for progressive disease (PD) (if applicable) and survival in 6-month intervals and will not be provided treatment with tecemotide (L-BLP25).
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed written informed consent. * Registration and treatment in a clinical trial with tecemotide (L-BLP25) under sponsorship of Merck KGaA/EMD Serono/Merck Serono Japan (feeder trial). \[Note, subjects who have been allocated to treatments not containing tecemotide (L BLP25) in the feeder trial are eligible for this trial and will be followed-up for progressive disease (PD) (if applicable) and survival.\] * End of Treatment procedures have been performed in the feeder trial. * Other protocol defined inclusion criteria could apply
Exclusion criteria
* Pregnancy and lactation period; women of childbearing potential, unless using effective contraception as determined by the Investigator. Subjects whom the Investigator considers may be at risk of pregnancy will have a pregnancy test performed per institutional standard * Known hypersensitivity to any of the trial treatment ingredients (if applicable) * Legal incapacity or limited legal capacity * Any other reason that, in the opinion of the Investigator, precludes the subject from participating in the trial * Other protocol defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years | An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is 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, AEs leading to discontinuation and AEs leading to death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | From randomization to death, assessed up to 3.6 years | Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive. |
Countries
Germany
Participant flow
Recruitment details
First/last subject (informed consent): January 2012/July 2012. Subjects randomized at 9 sites in Canada and Sweden.
Pre-assignment details
Subjects who participated in the tecemotide (L-BLP25) clinical trials (EMR 63325-005, EMR 63325-006, and EMR 63325-008 served as feeder studies) were considered in this follow-up study after the protocol specific inclusion and exclusion criteria to continue their maintenance treatment. A total of 27 subjects were enrolled in this follow-up study.
Participants by arm
| Arm | Count |
|---|---|
| Non-small Cell Lung Cancer (NSCLC) Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide. | 14 |
| Multiple Myeloma Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide. | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | Non-small Cell Lung Cancer (NSCLC) | Multiple Myeloma | Total |
|---|---|---|---|
| Age, Continuous | 67.7 Years STANDARD_DEVIATION 8.98 | 65.2 Years STANDARD_DEVIATION 9.81 | 66.5 Years STANDARD_DEVIATION 9.3 |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 13 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 12 | 7 / 8 |
| serious Total, serious adverse events | 8 / 12 | 0 / 8 |
Outcome results
Primary
Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE is 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, AEs leading to discontinuation and AEs leading to death.
Time frame: Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years
Population: Only subjects treated with tecemotide were included in the safety analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | AEs | 12 Subjects |
| Non-small Cell Lung Cancer (NSCLC) | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | Serious AE | 8 Subjects |
| Non-small Cell Lung Cancer (NSCLC) | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | AE leading to discontinuation | 2 Subjects |
| Non-small Cell Lung Cancer (NSCLC) | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | AE leading to death | 3 Subjects |
| Multiple Myeloma | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | AE leading to death | 0 Subjects |
| Multiple Myeloma | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | AEs | 7 Subjects |
| Multiple Myeloma | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | AE leading to discontinuation | 0 Subjects |
| Multiple Myeloma | Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death | Serious AE | 0 Subjects |
Secondary
Overall Survival (OS)
Overall survival time was defined as the time from randomization to death. Subjects without events were censored at the last date they were known to be alive.
Time frame: From randomization to death, assessed up to 3.6 years
Population: Efficacy analysis was not performed due to the premature termination of this safety follow-up study and the tecemotide program based on negative results in EMR 63325-009 (NCT00960115)