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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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

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:


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Anti-MUC1 T-cell response

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Andreas Schroeder, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck KGaA


Sweden: Medical Products Agency

Study ID:




Start Date:

February 2008

Completion Date:

March 2012

Related Keywords:

  • Multiple Myeloma
  • Phase II trial
  • Randomized
  • Cancer vaccine
  • MUC1
  • BLP 25
  • Multiple myeloma
  • BLP25 liposome
  • Stimuvax
  • Multiple Myeloma
  • Neoplasms, Plasma Cell