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

NCT00186316 | Completed Phase 1

• 3 other identifiers: BMT15579000NCT00186316
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Patient will complete 4 vaccinations of monthly interval

Secondary Outcomes (1)

• 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.

Interventions

Idiotype-pulsed allogeneic dendritic cells BIOLOGICAL

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. 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

You may not qualify if:

• 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
• \. 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:

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ronald Levy

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2003
• Primary Completion: April 1, 2006
• Study Completion: December 1, 2008
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

US (1)