Study With Stimuvax (L-BLP25) in Subjects With Either Chemotherapy-naïve, Slowly Progressive, Asymptomatic Multiple Myeloma or With Stage II/III Multiple Myeloma in Stable Response/Plateau Phase Following Anti-tumor Therapy
Inclusion Criteria:
- Documented previously untreated, 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
- Equal to or greater than 18 years of age
- Life expectancy of at least 6 months
- 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 109/L, WBC ≥2.5 x 109/L, and hemoglobin ≥90 g/L
- Total bilirubin less than or equal to 1.5 x upper reference range
- AST less than or equal to 2.5 x upper reference range
- Serum creatinine equal to or less than 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 (e.g. 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 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, e.g., 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