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Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01423760
First received: August 23, 2011
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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) can be enrolled in this follow-up trial to continue their maintenance treatment with Tecemotide (L-BLP25). Subjects will be transferred once all feeder trial objectives have been met. Subjects who received Tecemotide (L-BLP25) in a feeder trial will continue Tecemotide (L-BLP25) treatment in this follow-up trial and have safety assessments performed as well as be observed for progressive disease and survival in 6- month intervals. Subjects who had not received Tecemotide (L-BLP25) in feeder trials, or discontinued treatment will only be observed for progressive disease and survival in 6-month intervals and will not be provided treatment with Tecemotide (L-BLP25).


Condition Intervention
Non-Small Cell Lung Cancer
Multiple Myeloma
Biological: Tecemotide
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Long Term Safety - number of patients experiencing any adverse event [ Time Frame: Time from first dose up to 30 days after last dose of study treatment with L-BLP25 reported between day of first patient enrolled ] [ Designated as safety issue: Yes ]
    Listing of adverse event rate in patients receiving L-BLP25 only.


Secondary Outcome Measures:
  • Long Term Efficacy: Overall Survival (OS) [ Time Frame: Time from enrollment to death or last day known to be alive, reported between day of first patient enrolled (Dec 2011) until anticipated trial end (Dec 2019) (up to 8 years) ] [ Designated as safety issue: No ]
    Comparison of time of enrollment to death between L-BLP25 treatment and no treatment . Patients without an event will be censored at the last date known to be alive or at the anticipated trial end date, whichever is later.


Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tecemotide (L-BLP25) (plus active treatment if applicable) Biological: Tecemotide
Arm 1 is the treatment arm. Subjects who receive Tecemotide (L-BLP25) 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
Observation arm for survival of all subjects who do not receive anymore or have never received Tecemotide (L-BLP25)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 PD (if applicable) and survival.]
  • End of Treatment procedures have been performed in the feeder trial.

Additional inclusion criteria also 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.

Additional exclusion criteria also apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423760

Locations
United States, Massachusetts
US Medical Information
Rockland, Massachusetts, United States
Germany
Merck KGaA Communication Center
Darmstadt, Germany
Sponsors and Collaborators
Merck KGaA
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01423760     History of Changes
Other Study ID Numbers: EMR 63325-011
Study First Received: August 23, 2011
Last Updated: November 21, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Sweden: Medical Products Agency

Keywords provided by Merck KGaA:
vaccine
Stimuvax
Tecemotide
L-BLP25
Non-Small Cell Lung Carcinoma
Multiple Myeloma
EMR 63325-011
open label
immunotherapy
Merck Serono
Merck KGaA
EMD Serono

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Bronchial Neoplasms
Carcinoma, Bronchogenic
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lung Diseases
Lung Neoplasms
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Paraproteinemias
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014