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Common Safety Follow-up Trial of Tecemotide (L-BLP25)

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. 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
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

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).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Multiple Myeloma Biological: Tecemotide Other: No intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tecemotide (L-BLP25) Biological: Tecemotide
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

Observational 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).

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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 exclusion criteria could apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01423760

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Merck KGaA Communication Center
Darmstadt, Germany
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
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Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
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Responsible Party: Merck KGaA, Darmstadt, Germany Identifier: NCT01423760    
Other Study ID Numbers: EMR 63325-011
First Posted: August 26, 2011    Key Record Dates
Results First Posted: October 6, 2016
Last Update Posted: October 6, 2016
Last Verified: August 2016
Keywords provided by Merck KGaA, Darmstadt, Germany:
Non-Small Cell Lung Carcinoma
Multiple Myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases