West Cancer Center

MULTIPLE MYELOMA; Any line; Phase 1; "CFZ013"

Phase 1b study of carfilzomib administered once weekly in combination with lenalidomide and dexamethasone in subjects with multiple myeloma.

Title

Onyx CFZ013

Study Title

Phase 1b study of carfilzomib administered once weekly in combination with lenalidomide and dexamethasone in subjects with multiple myeloma.

Site Link

NCT02335983

Malignancy

Multiple Myeloma, MM

Stage

Stage 4

Disease Setting

Any

Line Of Therapy

1st or later line

Investigational Agent

carfilzomib

Drug Class

selective proteosome inhibitor

Jason Chandler, MD

Sponsor

Onyx Therapeutics

Phase

Phase 1

Status

Closed to Accrual

Key Eligibility Criteria

http://https://www.clinicaltrials.gov/ct2/show/NCT02335983

Key Eligibility Criteria Details

Newly diagnosed or refractory multiple myeloma
Measurable disease by either:
� Serum M protein
� Urine M protein
� qIgA (in IgA myeloma that can only be reliably measured this way)
ECOG PS 0-1
LVEF >40%
If prior tx with lenalidomide/dexamethasone must not have progressed within 3 months of starting therapy.
No Waldenstrom's macroglobulinemia or POEMS syndrome
No plasma cell leukemia, MDS, or amyloidosis
No prior tx with carfilzomib or oprozomib

Objective

Primary- AEs and SAEs; Secondary- AUC, Cmax, Tmax, half life, ORR, PFS, DOR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

No IgM subtype for those with newly diagnosed disease

Dosing Frequency

Carfilzomib- weekly

Control Agents

lenolidomide, dexamethasone

Study Protocol

Randomized