Multiple MyelomaPhase 1/2NCT00186316
Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
A Phase 1/2 study testing Idiotype-pulsed allogeneic dendritic cells in people with Multiple Myeloma, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Idiotype-pulsed allogeneic dendritic cells
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Dec 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
- 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
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.
Read the 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
- Being tested
- Idiotype-pulsed allogeneic dendritic cells
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idiotype-pulsed allogeneic dendritic cellsBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionApr 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Ronald Levy, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186316
- Sponsor's protocol ID
- BMT155
- Other IDs
- 79000, BMT155, NCT00186316
- Status last verified
- Aug 2009
- First submitted
- 13 Sep 2005
- Last updated
- 25 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Vaccine Therapy for Multiple Myeloma Utilizing Idiotype-Pulsed Allogeneic Dendritic Cells
- ClinicalTrials.gov ID
- NCT00186316
- Acronym / sponsor ID
- BMT155
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Idiotype-pulsed allogeneic dendritic cells | Biological | – |
Primary outcome
Patient will complete 4 vaccinations of monthly interval
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Levy principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Idiotype-pulsed allogeneic dendritic cells in people with Multiple Myeloma, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient will complete 4 vaccinations of monthly interval. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2009.