A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma (11-MM-01)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-Center Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide With Dexamethasone Prior to ASCT in Patients With Transplant Eligible Newly Diagnosed Myeloma|
- Adverse Events as a measure of safety and tolerability [ Time Frame: Throughout treatment, estimated to be 4-6 months per patients ] [ Designated as safety issue: Yes ]Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.
- Overall Response after induction therapy [ Time Frame: Every 28 days during induction therapy, estimated to be 4-6 months ] [ Designated as safety issue: No ]Overall response (PR, VGPR, CR, sCR)
- Overall Response post ASCT [ Time Frame: 3 and 6 months post ASCT ] [ Designated as safety issue: No ]Overall Response (PR, VGPR, CR, sCR) at 3 and 6 months post ASCT.
- Time to Progression [ Time Frame: Througout treatment and 3 and 6 months post ASCT ] [ Designated as safety issue: No ]Time to progression will be noted if it occurs within 6 months post ASCT.
- Progression Free Survival [ Time Frame: up to 6 months post ASCT ] [ Designated as safety issue: No ]
- Time to Next Therapy [ Time Frame: up to 6 months post ASCT ] [ Designated as safety issue: No ]Time to Next Therapy if occurs within 6 months post ASCT
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Carfilzomib, Cyclophosphamide, Dexamethasone
All eligible subjects will receive Carfilzomib, Cyclophosphamide, and Dexamethasone.
IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
Other Names:Drug: Cyclophosphamide
PO on days 1, 8, and 15 every 28 days
Other Name: CytoxanDrug: Dexamethasone
40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.
Other Name: Decadron
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660750
|United States, California|
|Samuel Oschin Comprehensive Cancer Center at Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Dominique Durant 310-248-8542 firstname.lastname@example.org|
|Contact: Premere Sessions email@example.com|
|Principal Investigator: Robert Vescio, MD|
|Comprehensive Cancer Center at Desert Regional Medical Center||Recruiting|
|Palm Springs, California, United States, 92262|
|Contact: Claudia Fortiche 760-416-4736 firstname.lastname@example.org|
|Principal Investigator: Elber Camacho, MD|
|United States, Massachusetts|
|University of Massachusettes Memorial||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Donna doBuono 508-856-1959 email@example.com|
|Contact: Kathryn Clarke Kathryn.Clarke@umassmemorial.org|
|Principal Investigator: Rajneesh Nath, MD|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Kimberly Oates 919-668-6524 firstname.lastname@example.org|
|Principal Investigator: Cristina Gasparetto, MD|
|United States, Washington|
|Fred Hutchinson Cancer Research Center||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Cari Morin 206-667-6238 email@example.com|
|Principal Investigator: William Bensinger, MD|
|Principal Investigator:||Jatin Shah, MD||Academic Myeloma Consortium|
|Principal Investigator:||Brian GM Durie, MD||Academic Myeloma Consortium|