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