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

August 10, 2016 updated by: Merck KGaA, Darmstadt, Germany

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Darmstadt, Germany
        • Merck KGaA Communication Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • L-BLP25
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening up to 42 days after last dose of study treatment with tecemotide (L-BLP25), assessed up to 3.6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization to death, assessed up to 3.6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (Estimate)

August 26, 2011

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 63325-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Tecemotide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe