WEEKLY CARFILZOMIB WITH DEXAMETHASONE FOR PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA: UPDATED RESULTS FROM THE PHASE 1/2 STUDY CHAMPION-1 (NCT01677858)
Author(s): ,
James Berenson
Affiliations:
Institute for Myeloma & Bone Cancer Research,Los Angeles, CA, United States,United States
,
Alan Cartmell
Affiliations:
Comprehensive Blood and Cancer Center,Bakersfield, CA, United States,United States
,
Roger Lyons
Affiliations:
US Oncology Research and Cancer Care Centers of South Texas,San Antonio, TX, United States,United States
,
Wael Harb
Affiliations:
Horizon Oncology Center,Lafayette, IN, United States,United States
,
Dimitrios Tzachanis
Affiliations:
Cedars-Sinai Medical Center,Los Angeles, CA, United States,United States
,
Richy Agajanian
Affiliations:
The Oncology Institute of Hope and Innovation,Downey, CA, United States,United States
,
Ralph Boccia
Affiliations:
Center for Cancer and Blood Disorders,Bethesda, MD, United States,United States
,
Morton Coleman
Affiliations:
NewYork-Presbyterian/Weill Cornell,New York, NY, United States,United States
,
Robert A Moss
Affiliations:
Robert A Moss MD Inc.,Fountain Valley, CA, United States,United States
,
Robert M Rifkin
Affiliations:
US Oncology Research and Rocky Mountain Cancer Centers,Denver, CO, United States,United States
,
Marco Schupp
Affiliations:
Amgen Inc.,Thousands Oaks, CA, United States,United States
,
Sandra Dixon
Affiliations:
Amgen Inc.,Thousands Oaks, CA, United States,United States
,
Ying Ou
Affiliations:
Amgen Inc.,Thousands Oaks, CA, United States,United States
,
Janet Anderl
Affiliations:
Amgen Inc.,Thousands Oaks, CA, United States,United States
Jesus Berdeja
Affiliations:
Sarah Cannon Research Institute,Nashville, TN,United States
EHA Learning Center. Berenson J. Jun 11, 2016; 133549
Mr. James Berenson
Mr. James Berenson

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Abstract
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Abstract: P661

Type: Poster Presentation

Presentation during EHA21: On Saturday, June 11, 2016 from 17:30 - 19:00

Location: Poster area (Hall H)

Background
Carfilzomib, an irreversible proteasome inhibitor, is approved as a single agent and in combination with dexamethasone in the United States (US) for the treatment of relapsed/refractory and relapsed multiple myeloma (MM), respectively and in the US and Europe in combination with lenalidomide (LEN)/dexamethasone for the treatment of relapsed MM. The approved dose/schedule of carfilzomib is a twice-weekly, 10-min intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle (starting dose: 20mg/m2 [cycle 1: days 1 and 2], escalating to 27mg/m2 thereafter).

Aims
A phase 1/2 study (CHAMPION-1; NCT01677858) to determine the maximum tolerated dose (MTD) of carfilzomib (phase 1), the overall response rate (ORR [≥partial response]) (phase 2) and safety of once-weekly carfilzomib with dexamethasone (Cd) in patients with relapsed or refractory MM.

Methods
Patients with relapsed or refractory MM (1−3 prior lines of therapy) received carfilzomib (30-min IV infusion) on days 1, 8, and 15 every 28 days. Phase 1: patients received carfilzomib 20mg/m2 on day 1 of cycle 1 followed by 45, 56, 70, or 88 mg/m2 beginning day 8 of cycle 1 in successive dose-level cohorts until the MTD was reached (using a standard 3+3 dose-escalation scheme). All patients received dexamethasone 40mg (IV or oral) days 1, 8, 15, and 22 (cycles 1–8); dexamethasone was omitted on day 22 cycles ≥9. Phase 2: patients received carfilzomib 20mg/m2 on cycle 1, day 1, escalating to the MTD for subsequent doses. Dexamethasone was given as previously. Cd was administered until unacceptable toxicity or disease progression. Blood samples were collected for pharmacokinetic and pharmacodynamic analyses.

Results
Patients with relapsed or refractory MM (1−3 prior lines of therapy) received carfilzomib (30-min IV infusion) on days 1, 8, and 15 every 28 days. Phase 1: patients received carfilzomib 20mg/m2 on day 1 of cycle 1 followed by 45, 56, 70, or 88 mg/m2 beginning day 8 of cycle 1 in successive dose-level cohorts until the MTD was reached (using a standard 3+3 dose-escalation scheme). All patients received dexamethasone 40mg (IV or oral) days 1, 8, 15, and 22 (cycles 1–8); dexamethasone was omitted on day 22 cycles ≥9. Phase 2: patients received carfilzomib 20mg/m2 on cycle 1, day 1, escalating to the MTD for subsequent doses. Dexamethasone was given as previously. Cd was administered until unacceptable toxicity or disease progression. Blood samples were collected for pharmacokinetic and pharmacodynamic analyses.

Conclusion
Once-weekly carfilzomib (70 mg/m2) with dexamethasone for patients with relapsed or refractory MM has an acceptable safety and tolerability profile with promising efficacy. The dose and schedule of carfilzomib used in this study (20/70mg/m2) is currently being compared with the regulatory-approved carfilzomib dose and schedule (20/27mg/m2 twice-weekly) in an ongoing phase 3, superiority study (ARROW; NCT02412878).



Session topic: Innovative therapies for MM 4

Keyword(s): Multiple myeloma, Refractory, Relapse
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