CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4 enrolled
Drug / intervention
MAGE-A3 +1 morebiological
Likely dose
MAGE-A3 or NY-ESO-1 peptide 300μg SC (with GM-CSF 500μg) at 2-week intervalsAI-extracted
Key inclusion· 7
  • ✓Active, symptomatic multiple myeloma meeting high-risk criteria (Salmon-Durie Stage IA&B with abnormal cytogenetics, IIA, IIB, IIIA, or IIIB)
  • ✓MAGE-A3 positive MM with HLA-A*0101 or HLA-B*35 (allocated to MAGE-A3 vaccine) OR NY-ESO-1 positive MM with HLA-A*0201 (allocated to NY-ESO-1 vaccine) OR NY-ESO-1 positive MM with dual HLA-A*0101/B*35 AND HLA-A*0201 (allocated to NY-ESO-1 vaccine) OR MAGE-A3 positive MM (regardless of NY-ESO-1 status) with dual HLA-A*0101/B*35 AND HLA-A*0201 (allocated to MAGE-A3 vaccine)
  • ✓Karnofsky performance score ≥70 (or ≥50 if solely due to myeloma bone pain)
  • ✓Age 18-70 years
Key exclusion· 8
  • ✕MGUS, indolent, or smoldering myeloma
  • ✕Prior chemotherapy or immunosuppressive treatment (e.g., glucocorticosteroids, cyclophosphamide, methotrexate) within 4 weeks before enrollment
  • ✕Other active malignancies except carcinoma-in-situ of cervix or non-melanomatous skin cancer
  • ✕Fever or active infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00090493
NCT00090493Phase 3Completed
CompareCT.gov

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

University of Arkansas·interventional·Posted Aug 31, 2004·Updated Jun 24, 2013

In Brief

A Phase 3 clinical trial evaluating MAGE-A3 and MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY for Multiple Myeloma. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 31, 2004
Enrollment StartJun 1, 2004
Primary CompletionJul 1, 2007
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 21.8 years ago

Interventions

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