Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Progressive Multiple Myeloma
|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: NCT01792102|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : March 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Carfilzomib and Dexamethasone||Phase 1 Phase 2|
This is a Phase 1/2, multicenter, open label, dose-escalation, nonrandomized study to evaluate the safety, pharmacodynamics, and efficacy of a 60-minute infusion of carfilzomib for patients with progressive multiple myeloma.
The study will consist of a screening period, followed by a treatment period of up to eight 28-day treatment cycles, followed by a period of maintenance treatment. Subjects are to be treated until disease progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2 Study of Safety, Efficacy, and Pharmacodynamics of a 60-Minute Infusion of Carfilzomib for Patients With Progressive Multiple Myeloma|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Carfilzomib and Dexamethasone
Phase 1: Carfilzomib will be administered at an escalating dose with dexamethasone administered at 8mg.
Phase 2: Carfilzomib will be administered at the MTD determined in phase 1. Maintenance: Carfilzomib and dexamethasone will be administered in the same fashion as the previous treatment cycles, but only on days 1, 2, 15, and 16.
Drug: Carfilzomib and Dexamethasone
Phase 1: Carfilzomib will be administered at an escalating dose by cohort as 60-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. On Cycle 1 Days 1 and 2, carfilzomib will be given at 20 mg/m^2. For all subsequent doses, carfilzomib will be administered at the dose assigned to the cohort (56, 70, or 88 mg/m^2). Dexamethasone (8 mg IV or PO) will be administered prior to carfilzomib on Days 1, 2, 8, 9, 15, and 16.
Phase 2: Carfilzomib will be administered at the MTD determined in phase 1. Maintenance: From Cycle 9 onward, carfilzomib and dexamethasone will be administered in the same fashion as during the previous treatment cycle, but only on days 1, 2, 15, and 16.
Other Name: Krypolis®
- Establish maximum tolerated dose (MTD) [ Time Frame: monthly, up to 24 months ]
Maximum tolerated dose will be established by the number of dose limiting toxicities and the overall safety and tolerability of the study drug.
Safety and tolerability will be determined by the following:
- incidence and frequency of adverse events throughout the study
- clinical laboratory test results at study visits
- vital signs measurements at each study visits
- medical history and physical examination findings
- ECOG performance status at study visits
- concomitant medication usage throughout the study
- Establish efficacy as assessed by the overall response rate [ Time Frame: monthly, up to 24 months ]
Response rate will be determined by the following:
- SPEP, UPEP, and quantification of immunoglobulins and immunofixation
- bone marrow aspirates and biopsies to confirm CR
- roentgenographic skeletal survey
Response rate will be assessed by the following:
- Clinical benefit response rate
- Progression-free survival
- Time to progression
- Duration of response
- Overall survival
- Relationship of 60-minute infusion of carflizomib with pharmacodynamic markers [ Time Frame: weekly for 2 months ]
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): NCT01792102
|United States, California|
|James R. Berenson M.D. Inc.|
|West Hollywood, California, United States, 90069|
|United States, New Jersey|
|John Theuer Cancer Center Hackensack University Medical Center|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||James Berenson, M.D.||James Berenson Inc.|
|Principal Investigator:||Joshua Richter, M.D||John Theurer Cancer Center at Hackensack University Medical Center|