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

NCT ID: NCT00186316

Last Updated: 2009-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Idiotype-pulsed allogeneic dendritic cells

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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

• Age >17 years
• HIV negative

Exclusion Criteria

• 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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Stanford University School of Medicine

Principal Investigators

Ronald Levy

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

79000

Identifier Type: -

Identifier Source: secondary_id

BMT155

Identifier Type: -

Identifier Source: secondary_id

NCT00186316

Identifier Type: -

Identifier Source: secondary_id

BMT155

Identifier Type: -

Identifier Source: org_study_id