Trial Search Results

Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Biological: Idiotype-pulsed allogeneic dendritic cells

Phase:

Phase 1/Phase 2

Eligibility


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

Ages Eligible for Study

17 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822