Symptomatic Multiple Myeloma after first-line autologous stem cell transplantation MedDRA version: 16.1 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Product Name: TriMix-DC
Product Code: TriMix-DC
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
Trade Name: REVLIMID 5 and 10 mg
Pharmaceutical Form: Capsule, hard
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For the standard primary treatment phase: 1.Able and willing to give valid written informed consent (IC1) before additional blood and bone marrow samples are collected. 2.Patients must have newly diagnosed symptomatic multiple myeloma. 3.Measurable disease. 4.Age at diagnosis : 18- 65 years. 5.Eligible for autologous stem cell transplantation. 6.Collection of adequate bone-marrow samples to construct patient-specific PCR probes for minimal residual disease analysis For leukapheresis: 1.Able and willing to give valid written informed consent (IC2) before leukapheresis. 2.Having reached at least partial remission after autolous stem cell transplantation. For the experimental treatment phase: 1.Able and willing to give valid informed consent (IC3) before the start of the experimental treatment 2.At least in complete remission or very good partial response after autologous stem cell transplantation with or without consolidation 3.Eastern Cooperative Oncology Group performance status of 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA FOR STANDARD TREATMENT PHASE Patients will be excluded for enrolment if they fulfil any of the following criteria: 1.Multiple myeloma of IgM subtype 2.POEMS syndrome 3.Plasma cell leukaemia or circulating plasma cells > 2 x 10E9/L. 4.Waldenstrom’s macroglobulinemia 5.Patients with known amyloidosis 6.HIV, HbsAg or hepatitis C serology positivity 7.History of other malignancy (other than basal cell carcinoma and carcinoma of the cervix in situ) 8.Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior to start standard treatment phase. 9.Female patients who are pregnant or lactating. 10.Any other clinically significant medical disease or psychiatric condition that, in the investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent. EXCLUSION CRITERIA FOR EXPERIMENTAL TREATMENT PHASE 1.Concomitant chemotherapy or other antimyeloma treatment 2.Concomitant immunosuppressive drugs including glucocorticosteroids 3.Any other clinically significant medical disease or psychiatric condition that, in the investigator’s opinion, may interfere with protocol adherence or a patient’s ability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunotherapy with autologous messenger RNA-electroporated monocyte derived dendritic cells in combination with lenalidomide maintenance will induce significant anti-tumor cellular immune responses in multiple myeloma patients achieving very good partial response or complete response after autologous stem cell transplantation. This will result in an improvement in response quality which will eventually lead to improved progression-free and overall survival.;Secondary Objective: 1.To demonstrate the in-vivo immunogenicity of autologous MAGE-A3 and MAGE-C1 mRNA-electroporated monocyte derived dendritic cell vaccinations in combination with lenalidomide maintenance as evaluated by : -Ex-vivo functional analysis including the demonstration of specific anti-MAGE-A3 and MAGE-C1 T cell immunoreactivity. -In-vivo delayed type hypersensitivity response assessment with MAGE-A3 and MAGE-C1 protein. 2.To determine progression-free survival and overall survival (OS). 3.Assessment of safety and toxicity of lenalidomide maintenance and dendritic cell vaccination.;Primary end point(s): To demonstrate a significant improvement in the response quality after dendritic cell vaccination in combination with lenalidomide maintenance. Improvement in response quality is defined as : -Achieving complete response after dendritic cells vaccination for patients in very good partial response before vaccination. -Achieving a minimal residual disease negative state after dendritic cell vaccination for patients with complete remission having minimal residual disease positive state before vaccination.;Timepoint(s) of evaluation of this end point: Continuously during the conduct of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.To demonstrate the in-vivo immunogenicity of autologous MAGE-A3 and MAGE-C1 mRNA-electroporated monocyte derived dendritic cell vaccinations in combination with lenalidomide maintenance as evaluated by : -Ex-vivo functional analysis including the demonstration of specific anti-MAGE-A3 and MAGE-C1 T cell immunoreactivity. -In-vivo delayed type hypersensitivity response assessment with MAGE-A3 and MAGE-C1 protein. 2.To determine progression-free survival and overall survival (OS). 3.Assessment of safety and toxicity of lenalidomide maintenance and dendritic cell vaccination.;Timepoint(s) of evaluation of this end point: Continuously during the conduct of the trial | — |
Countries
Belgium
Contacts
Public ContactRik Schots, MD,Phd
UZ Brussel
Outcome results
None listed