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ACTIVE NOT RECRUITING
NCT03352765
PHASE1

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

This study is testing a combination of chemo-immuno therapy called RBM. RBM consists of combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the participants own stem cells which is called autologous stem cell transplant (ASCT). Compared to the standard BEAM regimen, this RBM regimen may or may not be less effective in lymphoma, but will likely have fewer side effects.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2017-11-20

Completion Date

2026-11

Last Updated

2025-12-04

Healthy Volunteers

No

Conditions

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.

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States