Clinical trial · Interventional
Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma
Phase II Combination Immunotherapy After ASCT for Advanced Myeloma to Study MAGE-A3 Immunizations With Hiltonol® (Poly-ICLC) Plus Transfer of Vaccine-Primed Autologous T Cells Followed by Lenalidomide Maintenance
NCT01245673CI-TRIAL-00044491completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
One purpose of this study is to find out if a new combination of immune system treatments (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection ("immunity") against the myeloma cells. A second purpose is to find out how well this combination of immune system treatments is able to control the myeloma.
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 |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activated/costimulated autologous T-cell | Other | — | UNRESOLVED |
| MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC) | Biological | — | UNRESOLVED |
| Prevnar- Pneumococcal Conjugate Vaccine (PCV) | Biological | — | UNRESOLVED |
| Revlamid® (Lenalidomide) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevnar, T Cells, Lenalidomide, MAGE A-3
- description
- All patients will receive a priming immunization with a MAGE-A3/GM-CSF vaccine with adjuvant Hiltonol® (Poly-ICLC) along with the pneumococcal conjugate vaccine/PCV control vaccine about 10 days before a steady-state mononuclear cell apheresis. Patients will then undergo hematopoietic stem cell mobilization. All patients will receive high-dose melphalan followed by hematopoietic stem cells on day 0. On day +2, patients will receive anti-CD3/anti-CD28-costimulated autologous T cells. At days 14, 42, and 90, patients will receive MAGEA3/GM-CSF (+Hiltonol® Poly-ICLC) and PCV booster immunizations followed by restaging studies and immune assessments at day +100. At day 100, after immunizations and restaging, patients will start Revlamid® (Lenalidomide) maintenance therapy followed by 2 additional MAGE-A3 and PCV immunizations at days 120 and 150.
- interventionNames
- Biological: Prevnar- Pneumococcal Conjugate Vaccine (PCV)
- Other: Activated/costimulated autologous T-cell
- Drug: Revlamid® (Lenalidomide)
- Biological: MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC)
Primary outcomes (1)
- measure
- Primary Myeloma Endpoint
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Patients must be registered with the Sponsor's Monitor * Patients must have a diagnosis of myeloma * Patients must meet one of the following criteria: 1. Myeloma has relapsed, progressed, or failed to respond after at least one prior course of therapy (consisting of at least 2 treatment cycles or months of therapy). 2. Myeloma has responded partially to initial therapy but a complete response (immunofixation negative and normal serum free light chain studies)has NOT developed after a minimum of 3 cycles or months of initial therapy. 3. Myeloma has high-risk features as defined by the presence of one or more cytogenetic abnormalities known to confer a poor outcome even after standard autotransplants:complex karyotype (\> or = to 3 abnormalities),t(4;14),t(14;16),del (17)(p13.1),and/or chromosome 13 abnormalities. * Patients must have measurable disease on study entry * Patients must be between ages 18-80 (inclusive). * Patients should have adequate vital organ function as defined by the protocol. * ECOG performance status 0-2 (unless due solely to bone pain) * Prior to Lenalidomide maintenance phase, all study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test as per the protocol * Lenalidomide treatment phase: able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). Exclusion Criteria: * Pregnant or nursing females * HIV or HTLV-1/2 seropositivity * Known history of myelodysplasia * Known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy). * Active Hepatitis B (as defined by + Hepatitis B surface antigen); + Hepatitis C virus (HCV) antibody is NOT an exclusion * Prior autotransplant or allogeneic transplant * More than 4 distinct, prior courses of therapy for myeloma * History of severe autoimmune disease requiring steroids or other immunosuppressive treatments. * Active immune-mediated diseases including:connective tissue diseases, uveitis,sarcoidosis,inflammatory bowel disease, multiple sclerosis. * Evidence or history of other significant cardiac,hepatic,renal, ophthalmologic,psychiatric,or gastrointestinal disease which would likely increase the risks of participating in the study * Active bacterial, viral or fungal infections.
References
Publications (1)
- DERIVEDRapoport AP, Aqui NA, Stadtmauer EA, Vogl DT, Xu YY, Kalos M, Cai L, Fang HB, Weiss BM, Badros A, Yanovich S, Akpek G, Tsao P, Cross A, Mann D, Philip S, Kerr N, Brennan A, Zheng Z, Ruehle K, Milliron T, Strome SE, Salazar AM, Levine BL, June CH. Combination immunotherapy after ASCT for multiple myeloma using MAGE-A3/Poly-ICLC immunizations followed by adoptive transfer of vaccine-primed and costimulated autologous T cells. Clin Cancer Res. 2014 Mar 1;20(5):1355-65. doi: 10.1158/1078-0432.CCR-13-2817. Epub 2014 Feb 11. PMID 24520093