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

NCT01423760 | Terminated Results

• 1 other identifier: EMR 63325-011
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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) 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).

Conditions

Non-Small Cell Lung Cancer; Multiple Myeloma

Keywords

Vaccine; Stimuvax; Tecemotide; L-BLP25; Non-Small Cell Lung Carcinoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events (AEs), Serious AEs, AEs Leading to Discontinuation and AEs Leading to Death

  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 Outcomes (1)

• Overall Survival (OS)

  From randomization to death, assessed up to 3.6 years

Study Arms (2)

Tecemotide (L-BLP25)

EXPERIMENTAL

Biological: Tecemotide

Observational

OTHER

Other: No intervention

Interventions

Tecemotide BIOLOGICAL

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.

Also known as: L-BLP25

Tecemotide (L-BLP25)

No intervention OTHER

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).

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Merck KGaA Communication Center

Darmstadt, Germany

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Multiple Myeloma

Interventions

L-BLP25

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

The study was terminated prematurely as the sponsor decided to discontinue program with Tecemotide in non-small cell lung cancer (NSCLC).

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 26, 2011
• Study Start: January 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 6, 2016
• Results First Posted: October 6, 2016

Record last verified: 2016-08

Locations

DE (1)