Multiple MyelomaPhase 2NCT00083538
Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally
A Phase 2 study testing Dexamethasone, Thalidomide and Cisplatinum in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Dexamethasone, Thalidomide and Cisplatinum
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2001to Dec 2007
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have confirmed diagnosis of one of the following: Smoldering or indolent multiple myeloma, Multiple myeloma more than 1 year after autologous transplant and with stable disease, or Multiple myeloma with cytogenetic abnormalities
- Patients with secretory IgA or IgG must have purified idiotype protein available and/or tumor cells available, and patients with light chain or non-secretory myeloma must have tumor cells available
- Karnofsky performance score greater than or equal to 60
- ANC greater than or equal to 1,000/microliters, platelet count greater than or equal to 60,000/microliters, and CD4 count greater than or equal to 400/microliters.
- Expected survival of 3 months or more
- 18 years of age and older
- Have given a written consent and been informed about the investigational nature of the study.
- Negative serology for HIV, Hepatitis C, and negative for hepatitis B surface antigen
Who cannot join
- Patients with CD4 count < 400/microliters, and/or with severely damaged immune functions
- Chemotherapy or other immunosuppressive treatment with steroids, cytoxan, methotrexate within 8 weeks
- Fever or active infection
- Liver function: total bilirubin greater than or equal to 2 x ULN or AST/ALT greater than or equal to 3 x ULN
- Renal function: Patients on dialysis
- Simultaneous treatment with a second investigational drug or biologic agent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, 72205
About this study
Official title: UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients
The purpose of this study is to determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.
Read the detailed description
This is an experimental treatment that will consist of receiving special white blood cell administrations either underneath the skin or in the lymph nodes. In this protocol, treatment will be given according to the "risk group". If there are certain abnormalities in the chromosomes, the disease is considered to be high risk. High-risk patients will first receive one cycle of chemotherapy with a regimen called DT PACE, after which the white blood cells will be collected. Leukapheresis is a procedure in which blood is removed, white blood cells are saved, and the remaining blood is given back to you. These dendritic cells will then be mixed with your individual myeloma protein and/or cells, and keyhole limpet hemocyanin (KLH) that is necessary for the enhancement of immune response against myeloma antigens. It is hoped that this will cause these cells to interact with and activate T cells, which will then destroy myeloma cells in your body. Half of these white cells will be injected into your lymph nodes (intranodally) and half will be given subcutaneously. High risk patients will receive a chemotherapy regimen called DT PACE.
- Conditions
- Multiple Myeloma
- Being tested
- Dexamethasone, Thalidomide, Cisplatinum, Adriamycin, Cyclophosphamide
- Keywords
- Multiple Myeloma, DTPACE, Dexamethasone, Thalidomide, Cisplatin, Cytoxan, Doxorubicin, Etoposide, Dendritic Cell Vaccination, Leukapheresis
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
ThalidomideDrug
CisplatinumDrug
AdriamycinDrug
CyclophosphamideDrug
EtoposideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2004 (estimated)
- Study startFeb 2001
- Primary completionDec 2007
- Study completionDec 2007
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 University of ArkansasThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Investigators
- Van Rhee Frits, M.D., Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083538
- Sponsor's protocol ID
- UARK 2000-46
- Status last verified
- Jul 2010
- First submitted
- 25 May 2004
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UARK 2000-46, A Phase II Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally in Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT00083538
- Acronym / sponsor ID
- UARK 2000-46
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, DTPACE, Dexamethasone, Thalidomide, Cisplatin, Cytoxan, Doxorubicin, Etoposide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Feb 2001
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 May 2004 (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 determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.
Detailed description
This is an experimental treatment that will consist of receiving special white blood cell administrations either underneath the skin or in the lymph nodes. In this protocol, treatment will be given according to the "risk group". If there are certain abnormalities in the chromosomes, the disease is considered to be high risk. High-risk patients will first receive one cycle of chemotherapy with a regimen called DT PACE, after which the white blood cells will be collected. Leukapheresis is a procedure in which blood is removed, white blood cells are saved, and the remaining blood is given back to you. These dendritic cells will then be mixed with your individual myeloma protein and/or cells, and keyhole limpet hemocyanin (KLH) that is necessary for the enhancement of immune response against myeloma antigens. It is hoped that this will cause these cells to interact with and activate T cells, which will then destroy myeloma cells in your body. Half of these white cells will be injected into your lymph nodes (intranodally) and half will be given subcutaneously. High risk patients will receive a chemotherapy regimen called DT PACE.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have confirmed diagnosis of one of the following: Smoldering or indolent multiple myeloma, Multiple myeloma more than 1 year after autologous transplant and with stable disease, or Multiple myeloma with cytogenetic abnormalities
- Patients with secretory IgA or IgG must have purified idiotype protein available and/or tumor cells available, and patients with light chain or non-secretory myeloma must have tumor cells available
- Karnofsky performance score greater than or equal to 60
- ANC greater than or equal to 1,000/microliters, platelet count greater than or equal to 60,000/microliters, and CD4 count greater than or equal to 400/microliters.
- Expected survival of 3 months or more
Key exclusion criteria (6 listed)
- Patients with CD4 count < 400/microliters, and/or with severely damaged immune functions
- Chemotherapy or other immunosuppressive treatment with steroids, cytoxan, methotrexate within 8 weeks
- Fever or active infection
- Liver function: total bilirubin greater than or equal to 2 x ULN or AST/ALT greater than or equal to 3 x ULN
- Renal function: Patients on dialysis
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 |
|---|---|---|
| Dexamethasone | Drug | – |
| Thalidomide | Drug | – |
| Cisplatinum | Drug | – |
| Adriamycin | Drug | – |
| Cyclophosphamide | Drug | – |
| Etoposide | Drug | – |
Primary outcome
To determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.
Time frame: 24 months
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 7 Jul 2010.
- Myeloma Institute for Research \& Therapy websiteLink provided by the sponsor.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Van Rhee Frits, M.D. principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone, Thalidomide and Cisplatinum in people with Multiple Myeloma, run by University of Arkansas 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 8 inclusion and 6 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 7 Jul 2010. 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 phase mean?
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?
To determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses. (time frame: 24 months). 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 7 Jul 2010.