Multiple MyelomaPhase 1/2NCT00116441
Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma
A Phase 1/2 study testing Therapeutic Cellular Vaccine, GM-CSF Producing in people with Multiple Myeloma, run by Cell Genesys at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Therapeutic Cellular Vaccine, GM-CSF Producing
- Type of treatment
- Vaccines
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Oct 2004
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- De novo multiple myeloma
- ECOG 0-2
- No serious co-morbid illnesses and adequate organ function
- > 4 weeks from systemic steroids
Who cannot join
- No existing secondary malignancies and no history of secondary malignancies in the past 5 years
- No active autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line
The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line.
- Conditions
- Multiple Myeloma
- Being tested
- Therapeutic Cellular Vaccine, GM-CSF Producing
- Keywords
- Multiple Myeloma, Cancer, PSCT, Peripheral Stem Cell Transplant, Chemotherapy, GVAX
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Cellular Vaccine, GM-CSF ProducingBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple myeloma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startOct 2000
- Study completionOct 2004
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.
- 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
- 22 participants
Sponsor and investigators
- Lead sponsor
- Cell Genesys
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116441
- Sponsor's protocol ID
- K-0007
- Other IDs
- K-0007
- Status last verified
- Dec 2007
- First submitted
- 29 Jun 2005
- Last updated
- 24 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma: The Use of Autologous Tumor Cells With an Allogeneic GM-CSF Producing Cell Line
- ClinicalTrials.gov ID
- NCT00116441
- Acronym / sponsor ID
- K-0007
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Cancer, PSCT, Peripheral Stem Cell Transplant, Chemotherapy, GVAX
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants
- Lead sponsor
- Cell GenesysIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Study completion
- Oct 2004
- First posted
- 30 Jun 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.
The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- De novo multiple myeloma
- ECOG 0-2
- No serious co-morbid illnesses and adequate organ function
- > 4 weeks from systemic steroids
Key exclusion criteria (2 listed)
- No existing secondary malignancies and no history of secondary malignancies in the past 5 years
- No active autoimmune disease
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 |
|---|---|---|
| Therapeutic Cellular Vaccine, GM-CSF Producing | Biological | – |
Primary outcome
Multiple myeloma
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 24 Dec 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Therapeutic Cellular Vaccine, GM-CSF Producing in people with Multiple Myeloma, run by Cell Genesys 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?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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 24 Dec 2007. 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?
Multiple myeloma. 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 24 Dec 2007.