Phase 2
N=34
Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT01094548 ↗Enrolled (actual)
34
Serious AEs
32.4%
Results posted
Feb 2016
Primary outcome: Primary: Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response — 8; 7 participants — p=1.0000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tecemotide (L-BLP25) (Biological); Single low dose cyclophosphamide (Drug); Multiple low dose cyclophosphamide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response |
8; 7 | 1.0000 |
| SECONDARY Number of Participants With Baseline Immune Response and Initial Increase of MUC1 Specific Immune Response |
10; 7; 8; 7 | — |
| SECONDARY Number of Participants With Overall Induced Immune Response by Human Leukocyte-associated Antigen (HLA) Type |
2; 3; 6; 4; 5; 4 | — |
| SECONDARY Percentage of Participants With Objective Clinical Response (Complete Response [CR], or Partial Response [PR], or Minimal Response [MR] |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Time to Progression (TTP) |
15.2; 38.9 | 0.0940 |
| SECONDARY Time to Anti-tumor Therapy |
24.7; 36.7 | 0.3919 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs),Serious TEAEs, TEAEs of Grade 3 or 4 According to NCI-CTCAE v3.0, TEAEs Leading to Discontinuation and Injection Site Reactions (ISRs) |
17; 17; 6; 5; 5; 8 | — |
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 ( =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
Data sourced from ClinicalTrials.gov (NCT01094548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.