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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
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
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.
bendamustine
bendamustine 160 mg/m2 intravenously on days -3 and -2
melphalan
melphalan 140 mg/m2 intravenously on day -1 before the reinfusion of autologous stem cells on day 0.
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