Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Closed Not specified NCI, Other BMT155 79000, BMT155, NCT00186316, NCT00186316

Trial Description

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.

Further Study Information

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

Eligibility Criteria

Inclusion Criteria:1. For specimen collection and idiotype protein development:

• Must be secretory myeloma with at least .5g/dl serum IgG protein

• Clincally 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 blilirubin < 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 (allodonor is the same donor used for non-myeloablative transplant)

• Age >17 years

• HIV negative

• Must provide signed, informed consent&#xA;

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. Mycophenylate 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. Tacrolimis (FK506)- no greater than 4mg/day

Trial Contact Information

Trial Lead Organizations/Sponsors

Stanford Cancer Center

Ronald Levy

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00186316
Information obtained from ClinicalTrials.gov on October 07, 2008