Full Text View
Tabular View
No Study Results Posted
Related Studies
Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma
This study is currently recruiting participants.
Verified by University of Arkansas, December 2007
First Received: August 26, 2004   Last Updated: December 7, 2007   History of Changes
Sponsored by: University of Arkansas
Information provided by: University of Arkansas
ClinicalTrials.gov Identifier: NCT00090493
  Purpose

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 Intervention Phase
Multiple Myeloma
Biological: MAGE-A3
Phase II
Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • The hope is that the peptide vaccines will stimulate the immune system to attack and kill the myeloma cells. The Generate anti-myeloma T-cells [ Time Frame: 380 ] [ Designated as safety issue: No ]
  • Kill myeloma cells and nothing else [ Time Frame: 380 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2003
Estimated Study Completion Date: January 2013
Intervention Details:
    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.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00090493

Locations
United States, Arkansas
University of Arkansas for Medical Sciences/MIRT Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Cherie L Harless     501-296-1503 ext 1463     HarlessCherieL@uams.edu    
Contact: Mark A Mosby, BS, CCRP     501-296-1503 ext 1543     mamosby@uams.edu    
Sub-Investigator: Athanasios Fassas, M.D.            
Sub-Investigator: Bart Barlogie, M.D., Ph.D.            
Principal Investigator: Guido Tricot, M.D., Ph.D.            
Sub-Investigator: Elias Anaissie, M.D.            
Principal Investigator: Frits Van Rhee, M.D., Ph.D.            
Sub-Investigator: Maurizio Zangari, M.D.            
Sub-Investigator: Raymond Thertulien, M.D., Ph.D.            
Sub-Investigator: Michele H Fox, M.D, Ph.D.            
Sub-Investigator: John Shaughnessy, Ph.D.            
Sub-Investigator: Edgardo Angtuaco, M.D.            
Sub-Investigator: Eren Erdem, M.D.            
Sub-Investigator: Ronald Walker, M.D.            
Sub-Investigator: Susann Szmania, BS            
Sub-Investigator: Elias Kiwan, M.D.            
Sub-Investigator: Somashekar Krishna, M.D.            
Sub-Investigator: Nidhi Jain, M.D.            
Sub-Investigator: Mauricio Pineda-Roman, M.D.            
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Frits van Rhee, M.D., Ph.D. Myeloma Institute for Research & Therapy
  More Information

Additional Information:
No publications provided

Responsible Party: University_of_Arkansas ( Frits van Rhee, M.D., Ph.D., MRCP(UK), FRCPath )
Study ID Numbers: UARK 2003-26
Study First Received: August 26, 2004
Last Updated: December 7, 2007
ClinicalTrials.gov Identifier: NCT00090493     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
Myeloma
Mage-A3
Transplant
Peptide
DTPACE
vaccines
Immunotherapy
NY-ESO-1

Study placed in the following topic categories:
Immunoproliferative Disorders
Hemorrhagic Disorders
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Adjuvants, Immunologic
Vascular Diseases
Paraproteinemias
Lymphoproliferative Disorders
Hemostatic Disorders
Neoplasms, Plasma Cell
Multiple Myeloma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 06, 2009