High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma

Phase 2 Completed 75 enrolled M.D. Anderson Cancer Center

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory myeloma. The safety of this study treatment will also be studied.

Timeline

Start: 2010-11-08
Primary completion: 2017-09-20
Completion: 2017-09-20

Publications

Nieto Y, Valdez BC, Pingali SR, Bassett R, Delgado R, Nguyen J, Shah N, Popat U, Jones RB, Andersson BS, Gulbis A, Ahmed S, Bashir Q, Parmar S, Patel K, Myers A, Rondon G, Orlowski RZ, Champlin R, Qazilbash M. High-dose gemcitabine, busulfan, and melphalan for autologous stem-cell transplant in patients with relapsed or refractory myeloma: a phase 2 trial and matched-pair comparison with melphalan. Lancet Haematol. 2017 Jun;4(6):e283-e292. doi: 10.1016/S2352-3026(17)30080-7. Epub 2017 May 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Busulfan	Small molecule	4000 unknown	Intravenous
Subject	Gemcitabine	Small molecule	1875 mg/m2	Intravenous
Subject	Melphalan	Small molecule	60 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	8 mg	Intravenous
Background	G-CSF	Unknown	5 ug/kg	Subcutaneous
Background	Palifermin	Protein / enzyme biologic	60 ug/kg	Intravenous

High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma

Summary

Timeline

Publications

Drugs

Indications