A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols
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|ClinicalTrials.gov Identifier: NCT00884312|
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Solid Tumors||Drug: Carfilzomib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Arm, Phase 2 Study of Extended Carfilzomib Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols|
|Actual Study Start Date :||April 9, 2009|
|Actual Primary Completion Date :||May 17, 2017|
|Actual Study Completion Date :||May 17, 2017|
Participants received carfilzomib administered intravenously, using the same method, frequency, and dose level as in the last cycle of the participant's previous carfilzomib study. Treatment was continued until confirmation of disease progression, diagnosis of new malignancy, unacceptable toxicity, investigator discretion, voluntary withdrawal, or commercial availability of carfilzomib.
Carfilzomib dose levels ranged from 11 to 27 mg/m² for 2- to 10-minute infusions and 36 to 56 mg/m² for 30-minute infusions. Carfilzomib doses were administered on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Dose level reduction to a minimum dose of 11 mg/m² for toxicity was permitted.
- To evaluate the safety and efficacy of long-term or continuing carfilzomib treatment in subjects who have completed previous carfilzomib treatment. [ Time Frame: Assessments occur every 3 cycles ]
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): NCT00884312
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