A Phase II Study of Carfilzomib in Relapsed Waldenström's Macroglobulinemia (WM) IST-CAR-531

PHASE2CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

September 30, 2014

Study Completion Date

October 31, 2018

Conditions
Waldenstrom Macroglobulinemia
Interventions
DRUG

Carfilzomib

If you decide to participate in the study, you will receive carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study.

DRUG

Rituximab

"If you decide to participate in the study, in addition to the carfilzomib and possible dexamethasone administration, If less than a partial remission (PR) after 4 cycles is achieved, rituximab 375 mg/m2 on day 16 of each subsequent cycle will be added to the treatment. Subjects who meet the criteria for progression prior to 4 cycles of therapy will have rituximab 375 mg/m2 weekly for 4 consecutive weeks every 3 cycles added to the treatment. Subjects will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.~At the beginning of every cycle, your study doctor will see if your general health is satisfactory. You will be asked to report any side effects or problems you have had since the start of the last treatment cycle as well as any medication change(s)."

DRUG

Dexamethasone

"If you decide to participate in the study, you will receive carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study.~You will also receive dexamethasone weekly on Days 1, 2, 8, 9, 15 and 16 starting with cycle 1 and continuing every cycle thereafter."

Trial Locations (1)

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Onyx Therapeutics, Inc.

INDUSTRY

lead

Hackensack Meridian Health

OTHER