NCT00477815View on ClinicalTrials.gov

Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan, Melphalan, and Autologous Peripheral Stem Cell Transplant in Treating Patients With Previously Treated Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

July 28, 2011

Study Completion Date

May 7, 2018

Conditions
Multiple Myeloma and Plasma Cell Neoplasm
Interventions
BIOLOGICAL

rituximab

375 mg/m2 given as an IV infusion once weekly for four doses (days 1, 8, 15, and 22)

DRUG

melphalan

100/m2 in 1000 ml 0.9% NaCI IV infusion over 1 hour daily x 2 days.

BIOLOGICAL

Stem Cell

greater than or equal to 2 x 106 CD34+/kg by IV

BIOLOGICAL

Sargramostim (GM-CSF)

500 mcg by Subcutaneous QD

RADIATION

90Y-Zevalin

Dose escalation scheme. The dose of Zevalin will be based on the calculated radiation to the liver.

BIOLOGICAL

111In Zevalin

5.0 mCi by IV

Trial Locations (1)

55905

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

Mayo Clinic
All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Mayo Clinic

OTHER

NCT00477815 - Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan, Melphalan, and Autologous Peripheral Stem Cell Transplant in Treating Patients With Previously Treated Multiple Myeloma | Biotech Hunter | Biotech Hunter