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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cyclophosphamide; Vaccines

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