Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Tecemotide (L-BLP25); Tecemotide (L-BLP25); Single low dose cyclophosphamide; Multiple low dose cyclophosphamide
Intervention description: 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.; 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.; 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.; 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 MeSH terms: Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: L-BLP25 liposome; 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