Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy

NCT ID: NCT01094548

Last Updated: 2016-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-03-31

Brief Summary

Tecemotide (L-BLP25) is believed to induce a Mucinous glycoprotein 1 (MUC1)-specific T-cell response after vaccination. The primary purpose of this study is to ascertain whether vaccination with tecemotide (L-BLP25) induces a MUC1-specific T-cell response in slowly progressive or chemotherapy naive multiple myeloma subjects.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tecemotide (L-BLP25) plus single low dose cyclophosphamide

Group Type: EXPERIMENTAL

Tecemotide (L-BLP25)

Intervention Type: BIOLOGICAL

After receiving single low dose of cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy is documented.

Single low dose cyclophosphamide

Intervention Type: DRUG

An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment.

Tecemotide (L-BLP25) plus multiple low dose cyclophosphamide

Group Type: EXPERIMENTAL

Tecemotide (L-BLP25)

Intervention Type: BIOLOGICAL

After receiving multiple low dose of cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy is documented.

Multiple low dose cyclophosphamide

Intervention Type: DRUG

An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment plus an intravenous dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide (LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week 14 up to a maximum treatment period of 2 years.

Interventions

Tecemotide (L-BLP25)

After receiving single low dose of cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy is documented.

Intervention Type: BIOLOGICAL

Tecemotide (L-BLP25)

After receiving multiple low dose of cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy is documented.

Intervention Type: BIOLOGICAL

Single low dose cyclophosphamide

An intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment.

Intervention Type: DRUG

Multiple low dose cyclophosphamide

An IV infusion of 300 mg/m\^2 (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment plus an intravenous dose of cyclophosphamide (300 mg/m\^2, to a maximum of 600 mg) 3 days prior to the tecemotide (LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week 14 up to a maximum treatment period of 2 years.

Intervention Type: DRUG

Other Intervention Names

Stimuvax; Stimuvax

Eligibility Criteria

Inclusion Criteria

• Documented previously untreated, Mucinous glycoprotein 1 (MUC1)-expressing, slowly progressive asymptomatic multiple myeloma with an increasing M-protein concentration displayed on two occasions separated by an interval of at least 4 weeks within the last 18 months, or
• Documented MUC1-expressing stage II or III multiple myeloma with a treatment-free interval of at least 3 months following prior anti-tumor therapy, and fulfilling criteria for having a stable response/plateau phase
• Signed written informed consent
• MUC1-expressing myeloma cells in the bone marrow
• Greater than or equal to (>=) 18 years of age
• Life expectancy of at least 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 1 at study entry
• Effective contraception for both male and female subjects, if the possibility of conception exists
• A platelet count >=100 x 10^9/Liter, white blood cells >=2.5 x 10^9/Liter, and hemoglobin >=90 gram per liter (g/L)
• Total bilirubin <= 1.5 x upper reference range
• Aspartate aminotransferase (AST) <= 2.5 x upper reference range
• Serum creatinine <= 2 x upper reference

Exclusion Criteria

Pre-Therapies:

• Previous exposure to MUC1 targeting therapy
• Radiotherapy or any investigational drug in the 30 days before the start of treatment in this study
• Receipt of immunotherapy (Example: interferons, tumor necrosis factor [TNF], interleukins, or biological response modifiers [granulocyte macrophage colony stimulating factor {GM-CSF}, granulocyte colony stimulating factor {G-CSF}, macrophage-colony stimulating factor {M-CSF}], monoclonal antibodies) within 4 weeks (28 days) prior to randomization
• Any preexisting medical condition requiring chronic oral or intravenous steroid or immunosuppressive therapy except for maintenance doses of prednisone of <=10 milligram per day (mg/day)

Medical Conditions:

• Autoimmune disease that in the opinion of the investigator could compromise the safety of the subject in this study
• Hereditary or congenital immunodeficiencies
• Known hypersensitivity reaction to any of the components of study treatments
• Clinically significant cardiac disease, Example: New York Heart Association (NYHA) classes III-IV; unstable angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months
• Other previous malignancies within 5 years, with exception of a history of a previous basal cell carcinoma of the skin, carcinoma in situ of uterine cervix, gastrointestinal intramucosal carcinoma
• Known Hepatitis B and/or C
• Splenectomy

Standard Safety:

• Known alcohol or drug abuse
• Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
• Significant disease which, in the investigator's opinion, would exclude the subject from the study
• Pregnant or breast-feeding women, 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
• Participation in another clinical study within the past 30 days
• Legal incapacity or limited legal capacity
• Concurrent treatment with a non-permitted drug
• Any other reason that, in the opinion of the investigator, precludes the subject from participating in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck KGaA, Darmstadt, Germany

Locations

Please Contact the Merck KGaA Communication Center

Darmstadt, , Germany

Countries

Germany

References

Rossmann E, Österborg A, Löfvenberg E, et al. Randomized Phase II Study of BLP25 Liposome Vaccine (L-BLP25) in Patients with Multiple Myeloma. Am Soc Hematol. 53rd Annual Meeting, Dec 2011, Poster 2927.

Reference Type: BACKGROUND

Rossmann E, Osterborg A, Lofvenberg E, Choudhury A, Forssmann U, von Heydebreck A, Schroder A, Mellstedt H. Mucin 1-specific active cancer immunotherapy with tecemotide (L-BLP25) in patients with multiple myeloma: an exploratory study. Hum Vaccin Immunother. 2014;10(11):3394-408. doi: 10.4161/hv.29918.

Reference Type: DERIVED

PMID: 25483677 (View on PubMed)

Other Identifiers

EMR63325-008

Identifier Type: -

Identifier Source: org_study_id