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An Open-Label, Single-Arm, Phase 2 Study of Carfilzomib Maintenance Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

An Open-Label, Single-Arm, Phase 2 Study of Carfilzomib Maintenance Therapy in Subjects Previously Enrolled in Carfilzomib Treatment Protocols


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 14 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

evaluate the safety and efficacy of a long-term, twice weekly, every other week carfilzomib in subjects who have achieved and maintained a response to the completion of a previous carfilzomib treatment study

Outcome Time Frame:

Assessments occur during cycle 1, cycle 2, cycle 3, and every 3 cycles thereafter.

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

PX-171-010

NCT ID:

NCT00884312

Start Date:

April 2009

Completion Date:

April 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • proteasome
  • Hematological
  • carfilzomib
  • PR-171
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Washington University School of Medicine Saint Louis, Missouri  63110
Mount Sinai School of Medicine New York, New York  10029
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Northwestern University Chicago, Illinois  60611
Tower Cancer Research Foundation Beverly Hills, California  90211
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
The Cleveland Clinic Foundation Cleveland, Ohio  
University of Maryland, Greenebaum Cancer Center Baltimore, Maryland  21201
The University of Texas, MD Anderson Cancer Center Houston, Texas  77030
Texas Oncology Cancer Center Austin, Texas  78731
Sarah Cannon Research Institute Nashville, Tennessee  37203
Northwest Cancer Center Houston, Texas  77042
Weill Cornell Medical College New York, New York  10021
Winship Cancer Institute - Emory University Atlanta, Georgia  30322
University of California Medical Center San Francisco, California  94143
Colorado Blood Cancer Institute Denver, Colorado  80218
Pinnacle Oncology Hematology Scottsdale, Arizona  85258
Gabrail Cancer Center Research Canton, Ohio  44718
City of Hope National Medial Center Duarte, California  91010
John Theurer Cancer Center at Hackensack UMC Hackensack, New Jersey  07601