A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma (11-MM-01)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01660750|
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Carfilzomib Drug: Cyclophosphamide Drug: Dexamethasone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2015|
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
- Adverse Events as a measure of safety and tolerability [ Time Frame: Throughout treatment, estimated to be 4-6 months per patients ]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 ]Overall response (PR, VGPR, CR, sCR)
- Overall Response post ASCT [ Time Frame: 3 and 6 months post ASCT ]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 ]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 ]
- Time to Next Therapy [ Time Frame: up to 6 months post ASCT ]Time to Next Therapy if occurs within 6 months post ASCT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660750
|United States, California|
|Samuel Oschin Comprehensive Cancer Center at Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Comprehensive Cancer Center at Desert Regional Medical Center|
|Palm Springs, California, United States, 92262|
|United States, Massachusetts|
|University of Massachusettes Memorial|
|Worcester, Massachusetts, United States, 01655|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Jatin Shah, MD||AMyC|
|Principal Investigator:||Brian GM Durie, MD||AMyC|