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

Merck KGaA (EMD Serono)

Status

Terminated

Conditions

Multiple Myeloma

Non-Small Cell Lung Cancer

Treatments

Biological: Tecemotide

Other: No intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT01423760

EMR 63325-011

Details and patient eligibility

About

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).

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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