Clinical trial · Interventional
Study of Tecemotide (L-BLP25) in Subjects With Slowly Progressive Multiple Myeloma With no Symptoms and Who Have Had no Chemotherapy
A Randomized, Open-label, Phase II Study With Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiple low dose cyclophosphamide | Drug | — | UNRESOLVED |
| Single low dose cyclophosphamide | Drug | — | UNRESOLVED |
| Tecemotide (L-BLP25) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tecemotide (L-BLP25) plus single low dose cyclophosphamide
- interventionNames
- Biological: Tecemotide (L-BLP25)
- Drug: Single low dose cyclophosphamide
- type
- EXPERIMENTAL
- label
- Tecemotide (L-BLP25) plus multiple low dose cyclophosphamide
- interventionNames
- Biological: Tecemotide (L-BLP25)
- Drug: Multiple low dose cyclophosphamide
Primary outcomes (1)
- measure
- Number of Participants With Overall Induced Mucinous Glycoprotein-1 (MUC-1)-Specific Immune Response
- timeFrame
- From the date of randomization up to Week 104
- description
- The overall immune response was achieved at least for 2 timepoints; that is at least 1 parameter in at least 1 assay (Lymphoproliferation assay, enzyme-linked immunospot (ELISPOT) for interferon \[IFN\] gamma, and intracellular IFN gamma cytokine assay in peripheral blood mononuclear cell \[PBMC\]) with ratio to background \>=2, and ratio of background-corrected value to baseline \>=2;Specific immune response at a given timepoint 't' was considered as differences of log-scale values under stimulation (X vax,t ) to those of the respective unstimulated controls (Xneg,t, background values)were computed after certain assay-specific pre-processing steps: Yt = Xvax,t - Xneg,t; A participant was considered to show positive stimulation-induced immune response at timepoint 't' (POS\[t\]=1), upon fulfilling the following criteria: Yt =\>1 (That is at least a 2-fold higher value under stimulation than without stimulation). AVvax,t-1SEM vax,t \> AVneg,t+1SEMneg,t (ELISPOT and proliferation assay only).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 studyReferences
Publications (2)
- BACKGROUNDRossmann E, Österborg A, Löfvenberg E, et al. Randomized Phase II Study of BLP25 Liposome Vaccine (L-BLP25) in Patients with Multiple Myeloma. Am Soc Hematol. 53rd Annual Meeting, Dec 2011, Poster 2927.
- DERIVEDRossmann E, Osterborg A, Lofvenberg E, Choudhury A, Forssmann U, von Heydebreck A, Schroder A, Mellstedt H. Mucin 1-specific active cancer immunotherapy with tecemotide (L-BLP25) in patients with multiple myeloma: an exploratory study. Hum Vaccin Immunother. 2014;10(11):3394-408. doi: 10.4161/hv.29918. PMID 25483677