Multiple MyelomaPhase 2/3NCT00090493
Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma
A Phase 2/3 study testing MAGE-A3 and MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY in people with Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The hope is that the peptide vaccines will stimulate the immune system to attack and kill the myeloma cells. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else. 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?
- MAGE-A3 and MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to May 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- MM patients who have active, symptomatic myeloma, and meet the criteria below thus establishing the presence of high-risk myeloma
- MM Salmon-Durie Stage: IA\&B (with abnormal cytogenetics*), IIA, IIB, IIIA, and IIIB, and meet the criteria below thus establishing the presence of high-risk myeloma
- MM must meet one of the following criteria: a) Patients who have MAGE-A3 positive MM and who have the tissue type HLA-A*0101, or -* B35, are allocated to receive the MAGE-A3168-176 peptide vaccine. b) Patients who have NY-ESO-1 positive MM and who have the tissue type HLA-A*0201 are allocated to the NY-ESO-1156-C165V peptide vaccine. c) Patients who have NY-ESO-1 positive and MAGE-A3 negative or positive MM and who have as tissue type HLA-A*0101, or -* B35 and HLA-A*0201, will receive vaccination with the NY-ESO-1156-C165V peptide vaccine. d) Patients who have NY-ESO-1 negative and MAGE-A3 positive MM and who have as tissue type HLA-A*0101, or -* B35 and HLA-A*0201, will receive vaccination with the MAGE-A3 peptide vaccine.
- Karnofsky performance score ≥=70, unless bone pain caused by MM results in a Karnofsky score of > or =50.
- Age 18-70 years old
- Hb > or =8.0gm/dl, ANC > or =1,000/microliters, platelet count > or = 100,000/microliters.
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- Patients must have signed an IRB-approved consent form and been informed about the investigational nature of the study
- Negative serology for HIV, Hepatitis C and negative for Hepatitis B surface antigen.
- CD4+ count >400/microliters
- Life expectancy > 6 months
- Negative pregnancy test and females agree to two forms of contraception or abstinence.
- Provisional insurance approval for single or double auto-transplant(s)
Who cannot join
- MGUS, indolent and smoldering myeloma
- Chemotherapy or other immunosuppressive treatment e.g. gluco-corticosteroids, cyclophosphamide, methotrexate within the 4 weeks prior to enrollment
- Patients who have malignancies other than carcinoma-in-situ of the cervix or non-melanomatous skin cancer
- Fever or active infection
- Liver function: total bilirubin > 2.5xULN or AST/ALT >2.5xULN
- Renal function: patients on dialysis, or serum creatinine >2.0mg/dl
Show all 11Show fewer
- Simultaneous treatment with a second investigational drug or biologic agent for MM
- Other intercurrent serious illness, e.g. cardiac, pulmonary, hepatic disease, uncontrolled diabetes, etc
- Cardiac: Patients with recent (< or =6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO or must be > or = 50% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated
- Pulmonary: Patients must not have a history of chronic obstructive or chronic restrictive pulmonary disease resulting in unacceptable lung function: patients must have adequate pulmonary function studies > or = 50% of predicted on mechanical aspects (FEV1, FVC, etc) and diffusion capacity (DLCO) > or = 50% of predicted. Patients unable to complete pulmonary function tests due to myeloma related pain or fracture must have a high resolution CT scan of the chest and must also have acceptable arterial blood gases defined as P02 greater than 70
- Patients must be able to receive full doses of DT PACE, in the opinion of the treating investigator, with the exception of: A) Patients that have received prior adriamycin > 450 mg/m2 and LVEF < 55%. Adriamycin will be omitted in these patients. B) Patients with a creatinine clearance 30 - 50 ml/minute, who will receive 50% of the cisplatin dose
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 2003-26, A Pilot Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combination With DTPACE Chemotherapy and Autologous Transplantation in Multiple Myeloma
The hope is that the peptide vaccines will stimulate the immune system to attack and kill the myeloma cells. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else.
Read the detailed description
This is an experimental treatment that will consist of receiving peptide vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else.
The peptides are fragments from two tumor proteins called MAGE-A3 and NY-ESO-1. In order to be eligible for the study your myeloma cells must express either MAGE-A3 or NY-ESO-1, and your myeloma must be severe enough to require chemotherapy and stem cell transplantation. You must also have the appropriate HLA tissue type.
Patients who have MAGE-A3 positive myeloma and are HLA-A*0101 or -B*35 positive will receive the MAGE-A3 peptide vaccine.
Patients who have NY-ESO-1 positive myeloma and are HLA-A*0201 will receive the NY-ESO-1 peptide vaccine.
Three injections with 300µg per injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.
Your myeloma cells, obtained from a routine bone marrow aspirate, will be tested in the laboratory for the presence of MAGE-A3 and/or NY-ESO-1 proteins. HLA tissue type will be determined by standard methods in our Clinical Laboratory. This allows allocation of the correct vaccine to each individual patient.
Prior to starting a 6-day course of chemotherapy called DTPACE, white blood cells will be collected by a procedure called leukapheresis (leukapheresis no.1). Your white blood cells will be frozen for the duration of the chemotherapy in order to protect these white blood cells from the harmful effects of chemotherapy. After the chemotherapy is given, stem cells will be collected by leukapheresis (PBSC collection) and stored until the time of transplantation. After a short period of rest, the white blood cells from leukapheresis no.1 will be thawed and re-infused. This will ensure that you will have white blood cells that are in the best possible condition to respond to the peptide vaccines. A set of three vaccinations with the peptides at two-week intervals will follow. The hope is that the vaccinations will have generated precious anti-myeloma white blood cells.
You will again undergo leukapheresis (leukapheresis no.2) to collect the anti-myeloma white blood cells, which will be frozen in order to protect these precious cells from the chemotherapy drugs that will be infused just before the single or double auto-transplant.
A single dose of Melphalan will precede each transplant. The stem cells that were collected after DTPACE will be given for the transplants. For those receiving two transplants, a regimen of thalidomide with dexamethasone will be given for approximately 10 weeks between the two transplants. You will stop your thalidomide 28 days before the second transplant.
After completion of the transplants, the anti-myeloma white blood cells collected with leukapheresis no. 2 will be thawed and re-infused. These anti-myeloma cells will be boosted by three further peptide vaccinations at two-week intervals.
Finally, after you have completed these three vaccinations you will undergo another leukapheresis (no. 3). The anti-myeloma white blood cells collected with leukapheresis no. 3 will be frozen and stored for possible future use.
Six final vaccines will be given at monthly intervals to further amplify the anti-myeloma white blood cells.
- Conditions
- Multiple Myeloma
- Being tested
- MAGE-A3, MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
- Keywords
- Myeloma, Mage-A3, Transplant, Peptide, DTPACE, vaccines, Immunotherapy, NY-ESO-1
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGE-A3Biological
vaccinations at 2- week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating the patient 3 times at 14 day intervals (vaccination #4-6: days 82, 96, and 110). Vaccines #4-6 will be identical to vaccines 1-3. Thereafter, 6 monthly vaccines will be given to further boost the anti-MM-T-cells.
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPYBiological
Three injections with 300µg per injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals
| Study group | Role | What they receive |
|---|---|---|
| MAGE-A3 and NY-ESO-1 Immunotherapy | Experimental | Treatment will consist of receiving peptide vaccinations as a shot just under the skin (subcutaneous). Peptides are small pieces of proteins. We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else. Receives: Biological: MAGE-A3; Biological: MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Experiencing a Response to the Peptide Vaccines.
The peptides are fragments from two proteins MAGE-A3 and NY-ESO-1. There will be a series of 12 peptide vaccinations given as a subcutaneous (beneath the skin) injection (vaccines) at 2 week intervals resulting in an immune response to myeloma. The tumor peptides used in the vaccines are unique to myeloma, and it is not expected that there will be an immune response to normal organs. Myeloma cells must express MAGE-A3 or NY-ESO-1, be severe enough to require chemotherapy and stem cell transplantation and have appropriate HLA tissue type.
Measured: 2 week intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2004 (estimated)
- Study startJun 2004
- Primary completionJul 2007
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frits van Rhee, M.D., Ph.D., Principal investigator, Myeloma Institute for Research & Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090493
- Sponsor's protocol ID
- UARK 2003-26
- Status last verified
- May 2013
- First submitted
- 26 Aug 2004
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UARK 2003-26, A Pilot Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combination With DTPACE Chemotherapy and Autologous Transplantation in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00090493
- Acronym / sponsor ID
- UARK 2003-26
- Conditions
- Multiple Myeloma
- Keywords
- Myeloma, Mage-A3, Transplant, Peptide, DTPACE, vaccines, Immunotherapy, NY-ESO-1
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Aug 2004 (estimated)
- Results
- Posted 24 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hope is that the peptide vaccines will stimulate the immune system to attack and kill the myeloma cells. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else.
Detailed description
This is an experimental treatment that will consist of receiving peptide vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else.
The peptides are fragments from two tumor proteins called MAGE-A3 and NY-ESO-1. In order to be eligible for the study your myeloma cells must express either MAGE-A3 or NY-ESO-1, and your myeloma must be severe enough to require chemotherapy and stem cell transplantation. You must also have the appropriate HLA tissue type.
Patients who have MAGE-A3 positive myeloma and are HLA-A*0101 or -B*35 positive will receive the MAGE-A3 peptide vaccine.
Patients who have NY-ESO-1 positive myeloma and are HLA-A*0201 will receive the NY-ESO-1 peptide vaccine.
Three injections with 300µg per injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.
Your myeloma cells, obtained from a routine bone marrow aspirate, will be tested in the laboratory for the presence of MAGE-A3 and/or NY-ESO-1 proteins. HLA tissue type will be determined by standard methods in our Clinical Laboratory. This allows allocation of the correct vaccine to each individual patient.
Prior to starting a 6-day course of chemotherapy called DTPACE, white blood cells will be collected by a procedure called leukapheresis (leukapheresis no.1). Your white blood cells will be frozen for the duration of the chemotherapy in order to protect these white blood cells from the harmful effects of chemotherapy. After the chemotherapy is given, stem cells will be collected by leukapheresis (PBSC collection) and stored until the time of transplantation. After a short period of rest, the white blood cells from leukapheresis no.1 will be thawed and re-infused. This will ensure that you will have white blood cells that are in the best possible condition to respond to the peptide vaccines. A set of three vaccinations with the peptides at two-week intervals will follow. The hope is that the vaccinations will have generated precious anti-myeloma white blood cells.
You will again undergo leukapheresis (leukapheresis no.2) to collect the anti-myeloma white blood cells, which will be frozen in order to protect these precious cells from the chemotherapy drugs that will be infused just before the single or double auto-transplant.
A single dose of Melphalan will precede each transplant. The stem cells that were collected after DTPACE will be given for the transplants. For those receiving two transplants, a regimen of thalidomide with dexamethasone will be given for approximately 10 weeks between the two transplants. You will stop your thalidomide 28 days before the second transplant.
After completion of the transplants, the anti-myeloma white blood cells collected with leukapheresis no. 2 will be thawed and re-infused. These anti-myeloma cells will be boosted by three further peptide vaccinations at two-week intervals.
Finally, after you have completed these three vaccinations you will undergo another leukapheresis (no. 3). The anti-myeloma white blood cells collected with leukapheresis no. 3 will be frozen and stored for possible future use.
Six final vaccines will be given at monthly intervals to further amplify the anti-myeloma white blood cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAGE-A3 and NY-ESO-1 Immunotherapy | Experimental | Biological: MAGE-A3, Biological: MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPYTreatment will consist of receiving peptide vaccinations as a shot just under the skin (subcutaneous). Peptides are small pieces of proteins. We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. The purpose is to generate anti-myeloma T-cells which will kill myeloma cells and nothing else. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- MM patients who have active, symptomatic myeloma, and meet the criteria below thus establishing the presence of high-risk myeloma
- MM Salmon-Durie Stage: IA\&B (with abnormal cytogenetics*), IIA, IIB, IIIA, and IIIB, and meet the criteria below thus establishing the presence of high-risk myeloma
- MM must meet one of the following criteria: a) Patients who have MAGE-A3 positive MM and who have the tissue type HLA-A*0101, or -* B35, are allocated to receive the MAGE-A3168-176 peptide vaccine. b) Patients who have NY-ESO-1 positive MM and who have the tissue type HLA-A*0201 are allocated to the NY-ESO-1156-C165V peptide vaccine. c) Patients who have NY-ESO-1 positive and MAGE-A3 negative or positive MM and who have as tissue type HLA-A*0101, or -* B35 and HLA-A*0201, will receive vaccination with the NY-ESO-1156-C165V peptide vaccine. d) Patients who have NY-ESO-1 negative and MAGE-A3 positive MM and who have as tissue type HLA-A*0101, or -* B35 and HLA-A*0201, will receive vaccination with the MAGE-A3 peptide vaccine.
- Karnofsky performance score ≥=70, unless bone pain caused by MM results in a Karnofsky score of > or =50.
- Age 18-70 years old
Key exclusion criteria (11 listed)
- MGUS, indolent and smoldering myeloma
- Chemotherapy or other immunosuppressive treatment e.g. gluco-corticosteroids, cyclophosphamide, methotrexate within the 4 weeks prior to enrollment
- Patients who have malignancies other than carcinoma-in-situ of the cervix or non-melanomatous skin cancer
- Fever or active infection
- Liver function: total bilirubin > 2.5xULN or AST/ALT >2.5xULN
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 |
|---|---|---|
| MAGE-A3vaccinations at 2- week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating the patient 3 times at 14 day intervals (vaccination #4-6: days 82, 96, and 110). Vaccines #4-6 will be identical to vaccines 1-3. Thereafter, 6 monthly vaccines will be given to further boost the anti-MM-T-cells. | Biological | MAGE-A3 and NY-ESO-1 Immunotherapy |
| MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPYThree injections with 300µg per injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals | Biological | MAGE-A3 and NY-ESO-1 Immunotherapy |
Primary outcome
The Number of Participants Experiencing a Response to the Peptide Vaccines.
Time frame: 2 week intervals
The peptides are fragments from two proteins MAGE-A3 and NY-ESO-1. There will be a series of 12 peptide vaccinations given as a subcutaneous (beneath the skin) injection (vaccines) at 2 week intervals resulting in an immune response to myeloma. The tumor peptides used in the vaccines are unique to myeloma, and it is not expected that there will be an immune response to normal organs. Myeloma cells must express MAGE-A3 or NY-ESO-1, be severe enough to require chemotherapy and stem cell transplantation and have appropriate HLA tissue type.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Myeloma Institute for Research \& Therapy websiteLink provided by the sponsor.
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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.
Frits van Rhee, M.D., Ph.D. principal investigator
Myeloma Institute for Research & Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MAGE-A3 and MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY 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 12 inclusion and 11 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 Jun 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants Experiencing a Response to the Peptide Vaccines. (time frame: 2 week intervals). 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 Jun 2013.