TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03)

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

January 14, 2014

Primary Completion Date

September 14, 2016

Study Completion Date

September 14, 2016

Conditions
Multiple Myeloma, RelapsedMultiple Myeloma, Refractory to Standard Treatment
Interventions
RADIATION

Total Marrow Irradiation

Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day

DRUG

Melphalan

Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant

DRUG

Filgrastim (G-CSF)

Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days.

PROCEDURE

Autologous transplant

Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue

RADIATION

Total Marrow Irradiation

Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day

DRUG

Melphalan

Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant

DRUG

Filgrastim (G-CSF)

Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days

PROCEDURE

Autologous transplant

Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue

RADIATION

Total Marrow Irradiation

Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day

DRUG

Melphalan

Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant

DRUG

Filgrastim (G-CSF)

Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days

PROCEDURE

Autologous transplant

Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue

Trial Locations (1)

60612

University of Illinois Cancer Center, Chicago

All Listed Sponsors
lead

University of Illinois at Chicago

OTHER

NCT02043847 - TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03) | Biotech Hunter | Biotech Hunter