NCT01177683 - Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2017

Conditions

Multiple Myeloma

Interventions

DRUG

Bendamustine

"Phase I component:~Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4"

DRUG

Doxorubicin

"Phase I and II components:~Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4"

DRUG

Bortezomib

"Phase I and II components:~Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11"

DRUG

Bendamustine

"Phase II component:~Bendamustine at at MTD IV over 1 hour, Days 1 and 4"

DRUG

Filgrastim

"Phase II component:~Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000"

Trial Locations (7)

University of Rochester Medical Center, Rochester

University Hospitals Seidman Cancer Center, Cleveland

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

IU Health Central Indiana Cancer Centers, Indianapolis

Community Regional Cancer Center, Indianapolis

IU Health Arnett Cancer Center, Lafayette

Metro Health Cancer Care, Wyoming