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


Phase 1/Phase 2
17 Years
70 Years
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


To evaluate feasibility and safety of vaccination with allogeneic idiotype-pulsed dendritic
cells following mixed chimeric allogeneic transplantation for multiple myeloma.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient will complete 4 vaccinations of monthly interval

Principal Investigator

Ronald Levy

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BMT155

NCT ID:

NCT00186316

Start Date:

April 2003

Completion Date:

December 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Stanford University School of Medicine Stanford, California  94305-5317