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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
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
This is a multi-center, open-label, Phase 2 study of carfilzomib to monitor the safety and efficacy of long-term or continuing carfilzomib therapy for patients who previously completed a primary carfilzomib treatment study.

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Carfilzomib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Carfilzomib
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.
Drug: 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.
Other Names:
  • PR-171
  • PR171
  • Krypolis®



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previous completion of a carfilzomib study within 90 days prior to first dose of maintenance study drug.
  2. Disease Assessments performed within 30 days prior to first dose of maintenance study drug.
  3. Written informed consent in accordance with federal, local, and institutional guidelines
  4. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test, with a sensitivity of at least 50 mIU/mL, within 3 days prior to first dose of maintenance study drug.
  5. Subjects must agree to adhere to the study visit schedule and other study requirements and receive outpatient treatment and laboratory monitoring at the institution that administers the drug.

Exclusion Criteria:

  1. Administration of an intervening chemotherapy between the time of previous carfilzomib study termination and first dose of maintenance study drug.
  2. Pregnant or lactating females
  3. Diagnosis of a new malignancy of a different tumor type.

Information from the National Library of Medicine

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


  Show 23 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00884312     History of Changes
Other Study ID Numbers: PX-171-010
20130394 ( Other Identifier: Amgen Study ID )
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Amgen:
Multiple myeloma
proteasome
Hematological
carfilzomib
PR-171

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases