Clinical trial · Interventional
Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
NCT00186316CI-TRIAL-00002581completedPhase 1 / Phase 2ClinicalTrials.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)
Patients with Multiple myeloma who have undergone non-myeloablative allogeneic stem cell transplant will receive 6 vaccinations of donor derived dendritic cells combined with specific protein produced by multiple 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 |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Idiotype-pulsed allogeneic dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Patient will complete 4 vaccinations of monthly interval
Secondary outcomes (1)
- measure
- Evaluation of immune response. Immune response analysis will be done on all patients who are enrolled in the study. Patients who completed a minimum of 4 vaccinations will be included in immune response.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria:1. For specimen collection and idiotype protein development: * Must be secretory myeloma with at least .5g/dl serum IgG protein * Clinically stage 2 or 3 multiple myeloma * Karnofsky performance status of 70 or greater 2\. For Vaccination: * Eligible patients must have completed tandem autologous and nonmyeloablative allogeneic transplant for multiple myeloma at Stanford University Medical Center with stable disease or complete response to prevaccine therapy * Karnofsky performance status of 70 or greater. * ALT and AST must be \<2X upper limit of normal. Total bilirubin \< 1.5X upper limit of normal. * Serum creatinine \<1.5X upper limit of normal. * Hemoglobin \>9g/dl * Patients must be HIV negative. * Patients must provide signed, informed consent Donor Inclusion Criteria (allo donor is the same donor used for non-myeloablative transplant) * Age \>17 years * HIV negative * Must provide signed, informed consent Exclusion Criteria:1. For specimen collection and idiotype protein development: * Patients with non-secretory myeloma * Severe psychological or medical illness * Pregnant or lactating women * Subjects with \> Grade I toxicity by NCI-CTC v 3.0 * Subjects with prognosis \< 6 months 2\. For Vaccination: * \< 75 mg of idiotype protein purified from the patients serum * \< 25 million allogeneic idiotype-pulsed dendritic cells produced for vaccination * Evidence of grade II-IV acute GVHD (defined in section 5E) * Patients with evidence of myeloma disease progression as (defined below) * Severe psychological or medical illness or concomitant medications which may interfere with the study as determined by the clinical investigator * Patients on any other investigational agents * Pregnant or lactating women * Patients on any therapy for multiple myeloma or any chemotherapy drug, or immunomodulatory agent for treatment of multiple myeloma (e.g. thalidomide) * Any patient on more than two of the following immunosuppressive agents or at a dose greater than that indicated for a single immunosuppressive agent: 1. Mycophenolate Mofetil (MMF)- no greater than 1000mg twice a day 2. Prednisone- no greater than .5mg/kg/day 3. Cyclosporine- no greater than 300mg/day 4. Tacrolimus (FK506)- no greater than 4mg/day
References
Publications (0)
Data not yet available
No reference posted for this study.