Clinical trial NCT01094548 (phase 2, status: completed)
Conditions: multiple myeloma
ICD codes: C90.01, C90.02, C90.00
Drugs: single low dose cyclophosphamide, multiple low dose cyclophosphamide
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1
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