Clinical trial NCT00186316: Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
Official title: A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient will complete 4 vaccinations of monthly interval
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Ronald Levy
role: PRINCIPAL_INVESTIGATOR
References: