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A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00222105
First Posted: September 22, 2005
Last Update Posted: July 2, 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:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center
Results First Submitted: March 21, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Doxil
Drug: Thalidomide
Drug: Dexamethasone

  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
Arm 1

Doxil, Thalidomide, Dexamethasone

Doxil: Doxil 40 mg/m2 IV day 1

Thalidomide: 50-100 mg day 1-28

Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18


Participant Flow:   Overall Study
    Arm 1
STARTED   25 
COMPLETED   11 
NOT COMPLETED   14 
Removed due to wrong diagnosis                1 
Withdrawal by Subject                1 
Adverse Event                8 
Treatment delays                2 
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
Arm 1

Doxil, Thalidomide, Dexamethasone

Doxil: Doxil 40 mg/m2 IV day 1

Thalidomide: 50-100 mg day 1-28

Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18


Baseline Measures
   Arm 1 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Years]
Median (Full Range)
 61 
 (49 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  32.0% 
Male      17  68.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   25 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate   [ Time Frame: At End of Cycle 1, 28 Days ]

2.  Secondary:   Toxicity   [ Time Frame: End of study, up to 12 months ]


  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: Cancer Center Clinical Trials Office
Organization: University of Kansas Medical Center
phone: (913) 945-5059
e-mail: SWILLIAM@kumc.edu



Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00222105     History of Changes
Other Study ID Numbers: Doxil
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: March 21, 2017
Results First Posted: May 1, 2017
Last Update Posted: July 2, 2017