The purpose of this study is to determine the pharmacokinetics (PK) and safety for the combination of pomalidomide (POM) + low-dose dexamethasone (LD- DEX) in subjects with relapsed or refractory Multiple Myeloma (RRMM) and impaired renal function.
The primary objective of the study is to determine the PK and safety for the combination of POM + (LD-DEX) in subjects with RRMM and impaired renal function. The secondary objective of the study is to evaluate the efficacy of POM + (LD\_DEX) in subjects with RRMM and impaired renal function. This is a 3+3 dose escalation design, with one cohort each for patients with severely impaired renal function patients (CrCl \< 30 mL/min) requiring and not requiring dialysis respectively. There will also be one control cohort with normal renal function, these patients will receive 4 mg POM. Dosing will be 21 days out of a 28 day cycle.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Colorado Blood Cancer Institute
Denver, Colorado, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Ingalls Cancer Research Center
Harvey, Illinois, United States
Hackensack University Medical Center
PK-Area under the plasma concentration time curve (AUC)
PK-Area under the plasma concentration time curve (AUC)
Time frame: Up to 24 times over 7 months
PK-Time to maximum plasma concentration (Cmax)
PK-Time to maximum plasma concentration (Cmax)
Time frame: 24 times over 7 months
PK-Apparent total body clearance (CL/F)
PK-Apparent total body clearance (CL/F)
Time frame: 24 times up to 7 months
PK-Renal clearance (CLr)
PK-Renal clearance (CLr)
Time frame: 24 times over 7 months
PK-Apparent volume of distribution (V/F)
PK-Apparent volume of distribution (V/F)
Time frame: 24 times over 7 months
PK-Effective terminal half-life (T1/2)
PK-Effective terminal half-life (T1/2)
Time frame: 24 times over 7 months
Number of participants with adverse events (AEs)
Number of participants with adverse events (AEs)
Time frame: Up to 5 years
Number of participants alive
Number of participants alive
Time frame: Up to 5 years
Time to response
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Hackensack, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
L'Hotel Dieu de Quebec
Québec, Canada
Time to response
Time frame: Up to 5 years
Duration of response
Duration of response
Time frame: Up to 5 years