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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

July 31, 2007

Study Completion Date

May 31, 2012

Conditions
Multiple Myeloma
Interventions
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.

BIOLOGICAL

MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY

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

Trial Locations (1)

72205

University of Arkansas for Medical Sciences/MIRT, Little Rock

All Listed Sponsors
lead

University of Arkansas

OTHER

NCT00090493 - Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma | Biotech Hunter | Biotech Hunter