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Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351623
First Posted: May 11, 2011
Last Update Posted: April 13, 2017
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.
Collaborator:
Amgen
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: January 3, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: Carfilzomib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Carfilzomib

A single arm, open-label, single institution phase 2 clinical trial is planned.

Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.


Participant Flow:   Overall Study
    Carfilzomib
STARTED   44 
COMPLETED   35 
NOT COMPLETED   9 
Protocol Violation                2 
Adverse Event                4 
Withdrawal by Subject                1 
Death                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Carfilzomib

A single arm, open-label, single institution phase 2 clinical trial is planned.

Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.


Baseline Measures
   Carfilzomib 
Overall Participants Analyzed 
[Units: Participants]
 44 
Age 
[Units: Years]
Median (Full Range)
 63 
 (45 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      25  56.8% 
Male      19  43.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      9  20.5% 
Not Hispanic or Latino      34  77.3% 
Unknown or Not Reported      1   2.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   4.5% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      18  40.9% 
White      23  52.3% 
More than one race      0   0.0% 
Unknown or Not Reported      1   2.3% 
Region of Enrollment 
[Units: Participants]
 
United States   44 


  Outcome Measures

1.  Primary:   To Evaluate the Best Overall Response Rate (ORR)   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nikoletta Lendvai, MD
Organization: Memorial Sloan Kettering
phone: (212) 639-3368
e-mail: lendvain@mskcc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01351623     History of Changes
Other Study ID Numbers: 10-228
First Submitted: May 9, 2011
First Posted: May 11, 2011
Results First Submitted: January 3, 2017
Results First Posted: March 13, 2017
Last Update Posted: April 13, 2017