This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the study includes a Phase Ib combination part of AUY922 administered in combination with bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Mayo Clinic - Arizona Cancer Clinical Research Unit
Scottsdale, Arizona, United States
Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(3)
San Antonio, Texas, United States
Novartis Investigative Site
Melbourne, Australia
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Würzburg, Germany
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, Spain
The safe dose of AUY922 when administered once a week.
Time frame: 54 weeks (Maximum Tolerated Dose (MTD))
The safe dose of AUY922 when administered once a week in combination with bortezomib and dexamethasone.
Time frame: 24 weeks (MTD determination of dual and triple combination)
Efficacy of AUY922 administered once a week alone and in combination
Time frame: at baseline and every 2 cycles (time to document tumor progression)
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