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

Trial ID or NCT#

NCT00186316

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells

Eligibility Criteria

Ages Eligible for Study: 17 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. For specimen collection and idiotype protein development:
    1. * 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. 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
    1. Donor Inclusion Criteria (allo donor is the same donor used for non-myeloablative transplant)
  3. * Age \>17 years* HIV negative* Must provide signed, informed consent
Exclusion Criteria:
  1. 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. 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:
  3. 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
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Contact

BMT Referrals
6507230822

View on ClinicalTrials.gov