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N/A
18 Years
N/A
Open (Enrolling by invite only)
Both
Non-Small Cell Lung Cancer, Multiple Myeloma

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Trial Information


Inclusion Criteria:



- Signed written informed consent.

- Registration and treatment in a clinical trial with L BLP25 under sponsorship of
Merck KGaA / EMD Serono / Merck Serono Japan (feeder trial). [Note, subjects who have
been allocated to treatments not containing 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Long Term Safety - number of patients experiencing any adverse event

Outcome Description:

Listing of adverse event rate in patients receiving L-BLP25 only.

Outcome 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

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

EMR 63325-011

NCT ID:

NCT01423760

Start Date:

January 2012

Completion Date:

June 2020

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Multiple Myeloma
  • vaccine
  • Stimuvax
  • L-BLP25
  • Non-Small Cell Lung Carcinoma
  • Multiple Myeloma
  • EMR 63325-011
  • open label
  • immunotherapy
  • Merck Serono
  • Merck KGaA
  • EMD Serono
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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US Medical Information located in Rockland, Massachusetts