study of tecemotide (l-blp25) in subjects with slowly progressive multiple myeloma with no symptoms and who have had no chemotherapy

Conditions: Multiple Myeloma

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.


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

Keywords: l-blp25 liposome multiple myeloma