This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant eligible multiple myeloma.
This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant eligible multiple myeloma. The study will also explore the efficacy of Car-Cy-Dex including overall response after induction therapy, overall response at 3 and 6 months post ASCT, and time to progression, progression free survival, and time to next therapy if it occurs within 6 months post ASCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
PO on days 1, 8, and 15 every 28 days
40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.
Samuel Oschin Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, United States
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States
University of Massachusettes Memorial
Worcester, Massachusetts, United States
Duke University Medical Center
Durham, North Carolina, United States
Adverse Events as a measure of safety and tolerability
Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.
Time frame: Throughout treatment, estimated to be 4-6 months per patients
Overall Response after induction therapy
Overall response (PR, VGPR, CR, sCR)
Time frame: Every 28 days during induction therapy, estimated to be 4-6 months
Overall Response post ASCT
Overall Response (PR, VGPR, CR, sCR) at 3 and 6 months post ASCT.
Time frame: 3 and 6 months post ASCT
Time to Progression
Time to progression will be noted if it occurs within 6 months post ASCT.
Time frame: Througout treatment and 3 and 6 months post ASCT
Progression Free Survival
Time frame: up to 6 months post ASCT
Time to Next Therapy
Time to Next Therapy if occurs within 6 months post ASCT
Time frame: up to 6 months post ASCT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States