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Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090493
Recruitment Status : Completed
First Posted : August 31, 2004
Results First Posted : June 24, 2013
Last Update Posted : June 24, 2013
Information provided by (Responsible Party):
University of Arkansas

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: MAGE-A3 Biological: MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: MAGE-A3 and NY-ESO-1 Immunotherapy
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.
Biological: MAGE-A3
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.

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

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090493

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United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
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Principal Investigator: Frits van Rhee, M.D., Ph.D. Myeloma Institute for Research & Therapy
Additional Information:
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Responsible Party: University of Arkansas Identifier: NCT00090493    
Other Study ID Numbers: UARK 2003-26
First Posted: August 31, 2004    Key Record Dates
Results First Posted: June 24, 2013
Last Update Posted: June 24, 2013
Last Verified: May 2013
Keywords provided by University of Arkansas:
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases