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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Idiotype-pulsed allogeneic dendritic cells
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Mycophenolate Mofetil (MMF)- no greater than 1000mg twice a day Prednisone- no greater than .5mg/kg/day Cyclosporine- no greater than 300mg/day Tacrolimus (FK506)- no greater than 4mg/day

Sites / Locations

  • Stanford University School of Medicine

Outcomes

Primary Outcome Measures

Patient will complete 4 vaccinations of monthly interval

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2005
Last Updated
August 21, 2009
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00186316
Brief Title
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

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Idiotype-pulsed allogeneic dendritic cells
Primary Outcome Measure Information:
Title
Patient will complete 4 vaccinations of monthly interval
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: Mycophenolate Mofetil (MMF)- no greater than 1000mg twice a day Prednisone- no greater than .5mg/kg/day Cyclosporine- no greater than 300mg/day Tacrolimus (FK506)- no greater than 4mg/day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Levy
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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