Common Safety Follow-up Trial of Tecemotide (L-BLP25)
|ClinicalTrials.gov Identifier: NCT01423760|
Recruitment Status : Terminated (The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.)
First Posted : August 26, 2011
Results First Posted : October 6, 2016
Last Update Posted : October 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer Multiple Myeloma||Biological: Tecemotide Other: No intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Trial to Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2015|
|Experimental: Tecemotide (L-BLP25)||
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.
Other Name: L-BLP25
Other: No 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).
- Number of Subjects With Adverse Events (AEs), Serious AEs, 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 ]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.
- Overall Survival (OS) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423760
|Merck KGaA Communication Center|
|Study Director:||Medical Responsible||Merck KGaA|