Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: Multiple low dose cyclophosphamide

Biological: Tecemotide (L-BLP25)

Drug: Single low dose cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01094548

EMR63325-008

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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