Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 8, 2001

Primary Completion Date

January 12, 2008

Study Completion Date

January 12, 2008

Conditions
Multiple Myeloma
Interventions
DRUG

Myeloma Immunoglobulin Idiotype Vaccine

3 subcutaneous (SC) injections of myeloma protein within 10 weeks before stem cell collection the first (week 0), second (week 2), and third injection (week 6) with Id-KLH (0.5 mg SC day 1)

DRUG

Bortezomib

Induction chemotherapy: 1.3 mg/m\^2 bolus intravenous injection twice weekly for 2 weeks (days 1, 4, 8, 11) followed by 10 day rest period (day 12-21)

DRUG

Cyclophosphamide

Induction chemotherapy: 600 mg/m\^2 day 4 Transplant: 1200 mg/m\^2 intravenous x 4 days (days -6, -5, -4, -3)

DRUG

Cyclosporine

Transplant: 2 mg/kg intravenous every 12 hours continuous intravenous or by mouth (PO) until day + 180

DRUG

Doxorubicin hydrochloride

Induction chemotherapy: 10 mg/m\^2 day continuous intravenous (CIV) days 1-3

DRUG

Etoposide

Induction chemotherapy: 50 mg/m\^2 day continuous intravenous days 1-3

DRUG

Fludarabine phosphate

Induction chemotherapy: 25 mg/m\^2 day intravenous days 1-3 Transplant: 30 mg/m\^2 day x 4 days (days -6, -5, -4, -3 )

DRUG

Prednisone

60 mg/m\^2 day 1-4

DRUG

Vincristine Sulfate

Induction chemotherapy: 0.5 mg/m\^2 day continuous intravenous days 1-3

DRUG

Methotrexate

Transplant: 5 mg/m\^2 intravenous on days +1, +3, +6, +11

BIOLOGICAL

GMCSF (granulocyte macrophage colony stimulating factor)

250 mcg/m\^2 subcutaneously every day, days 1-4

BIOLOGICAL

GCSF (granulocyte colony stimulating factor)

10 mcg/kg per day subcutaneously daily from day 5 until absolute neutrophil count (ANC) \> 1000/ul x 2 days

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT00006184 - Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma | Biotech Hunter | Biotech Hunter