Clinical trial · Interventional
Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma
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
NCT00090493CI-TRIAL-00010973completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MAGE-A3 | Biological | — | UNRESOLVED |
| MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MAGE-A3 and NY-ESO-1 Immunotherapy
- description
- 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.
- interventionNames
- Biological: MAGE-A3
- Biological: MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
Primary outcomes (1)
- measure
- The Number of Participants Experiencing a Response to the Peptide Vaccines.
- timeFrame
- 2 week intervals
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * 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) Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.