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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01423760
• Other study ID #: EMR 63325-011
• Status: Terminated
• Phase: N/A
• First received: August 23, 2011
• Last updated: July 31, 2015
• Start date: January 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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) 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-Small Cell Lung Cancer

Intervention

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:
• No intervention
Observation arm for survival of all subjects who do not receive anymore or have never received Tecemotide (L-BLP25)

Locations

Country	Name	City	State
Germany	Merck KGaA Communication Center	Darmstadt
United States	US Medical Information	Rockland	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long Term Safety - number of patients experiencing any adverse event	Listing of adverse event rate in patients receiving L-BLP25 only.	Time from first dose up to 30 days after last dose of study treatment with L-BLP25 reported between day of first patient enrolled	Yes
Secondary	Long Term Efficacy: Overall Survival (OS)	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.	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)	No