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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186316
• Other study ID #: BMT155
• Secondary ID: 79000BMT155
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: August 21, 2009
• Start date: April 2003
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

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

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• Idiotype-pulsed allogeneic dendritic cells

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient will complete 4 vaccinations of monthly interval
Secondary	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.