Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma

Phase 1/2 Completed 57 enrolled Weill Medical College of Cornell University

Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autologous Stem Cell Transplant.

Timeline

Start: 2009-04-23
Primary completion: 2016-03-11
Completion: 2018-03-01

Outcome

Met primary endpoint

paper Sixteen out of the first 28 evaluable patients achieved CR/sCR, meeting the design criteria. PMID 31190006 ↗

Publications

Gomez-Arteaga A, Mark TM, Guarneri D, Christos PJ, Gergis U, Greenberg JD, Hsu J, Mayer SA, Niesvizky R, Pearse RN, Phillips AA, Rossi A, Coleman M, van Besien K, Shore TB. High-dose bendamustine and melphalan conditioning for autologous stem cell transplantation for patients with multiple myeloma. Bone Marrow Transplant. 2019 Dec;54(12):2027-2038. doi: 10.1038/s41409-019-0587-0. Epub 2019 Jun 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bendamustine	Small molecule	30 mg/m2	—
Subject	Bendamustine	Small molecule	60 mg/m2	—
Subject	Bendamustine	Small molecule	90 mg/m2	—
Subject	Bendamustine	Small molecule	120 mg/m2	—
Subject	Bendamustine	Small molecule	150 mg/m2	—
Subject	Bendamustine	Small molecule	225 mg/m2	—
Subject	Melphalan	Small molecule	140 mg/m2	—
Subject	Melphalan	Small molecule	200 mg/m2	—