Multiple Myeloma
Conditions
Brief summary
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.
Detailed description
To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic cells following mixed chimeric allogeneic transplantation for multiple myeloma.
Interventions
BIOLOGICALIdiotype-pulsed allogeneic dendritic cells
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient will complete 4 vaccinations of monthly interval | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed