Know Cancer

or
forgot password

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 CenterSeattle, Washington  98109
Washington University School of MedicineSaint Louis, Missouri  63110
Mount Sinai School of MedicineNew York, New York  10029
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Northwestern UniversityChicago, Illinois  60611
Tower Cancer Research FoundationBeverly Hills, California  90211
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
The Cleveland Clinic FoundationCleveland, Ohio  
University of Maryland, Greenebaum Cancer CenterBaltimore, Maryland  21201
The University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
Texas Oncology Cancer CenterAustin, Texas  78731
Sarah Cannon Research InstituteNashville, Tennessee  37203
Northwest Cancer CenterHouston, Texas  77042
Weill Cornell Medical CollegeNew York, New York  10021
Winship Cancer Institute - Emory UniversityAtlanta, Georgia  30322
University of California Medical CenterSan Francisco, California  94143
Colorado Blood Cancer InstituteDenver, Colorado  80218
Pinnacle Oncology HematologyScottsdale, Arizona  85258
Gabrail Cancer Center ResearchCanton, Ohio  44718
City of Hope National Medial CenterDuarte, California  91010
John Theurer Cancer Center at Hackensack UMCHackensack, New Jersey  07601