Status:
COMPLETED
Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma
Eligibility:
All Genders
17-70 years
Phase:
PHASE1
PHASE2
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...
Detailed Description
To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic cells following mixed chimeric allogeneic transplantation for multiple myeloma.
Eligibility Criteria
Inclusion
- 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
- 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:
- Mycophenolate Mofetil (MMF)- no greater than 1000mg twice a day
- Prednisone- no greater than .5mg/kg/day
- Cyclosporine- no greater than 300mg/day
- Tacrolimus (FK506)- no greater than 4mg/day
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00186316
Start Date
April 1 2003
End Date
December 1 2008
Last Update
August 25 2009
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305