A Phase I Study of Bendamustine and Melphalan Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

November 20, 2017

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Lymphoma
Interventions
DRUG

rituximab

rituximab 375 mg/m2 on days -11 and -4, The second dose of rituximab (day -4) is administered 7 days after the first dose (day -11), +/- 1 day. Rituximab may be administered by a local oncologist. If the participant has a CD20 negative tumor, rituximab can be omitted from the conditioning regimen.

DRUG

bendamustine

bendamustine 160 mg/m2 intravenously on days -3 and -2

DRUG

melphalan

melphalan 140 mg/m2 intravenously on day -1 before the reinfusion of autologous stem cells on day 0.

PROCEDURE

Autologous Stem Cell Transplantation (ASCT)

reinfusion of autologous stem cells on day 0.

Trial Locations (1)

10065

Memorial Sloan Kettering Cancer Center, New York

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER