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2006-32 Phase II Study of Rapidly Recycled High Dose DTPACE

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577512
First Posted: December 20, 2007
Last Update Posted: November 20, 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.
Information provided by (Responsible Party):
University of Arkansas
Results First Submitted: April 19, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: DTPACE

  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
No text entered.

Reporting Groups
  Description
HD DTPACE
  1. High dose DTPACE (dexamethasone 200 mg days 1-7; thalidomide 200 mg days 1-4; cisplatin 15 mg/m2 days 1-4; adriamycin 15 mg/m2 days 1-4; cyclophosphamide 600 mg/m2 days 1-4; etoposide 60 mg/m2 days 1-4) and stem cell collection if you do not already have sufficient stem cells stored
  2. High dose DTPACE and stem cell re-infusion repeated every 18-21 days for 4 cycles
  3. Bortezomib (1.0 mg/m2 Day 1, 4, 8, 11), thalidomide (100 mg/m2 days 1-21), and dexamethasone (20 mg days 1-4 and 9-12) (VTD) Maintenance therapy

Participant Flow:   Overall Study
    HD DTPACE
STARTED   4 
COMPLETED   0 
NOT COMPLETED   4 



  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
HD DTPACE
  1. High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored
  2. High dose DTPACE and stem cell re-infusion
  3. VTD Maintenance therapy

Baseline Measures
   HD DTPACE 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      4 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.3  (6.24) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  50.0% 
Male      2  50.0% 
Region of Enrollment 
[Units: Participants]
 
United States   4 


  Outcome Measures

1.  Primary:   Number of Subjects Treated With (HD DTPACE Obtain a Complete Response or Near Complete Response That Lasts for 6 Months or Longer.   [ Time Frame: 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: Nathan M. Petty
Organization: University of Arkansas for Medical Sciences, Myeloma Institute
phone: 501-526-6990 ext 2461
e-mail: pettynathanm@uams.edu



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00577512     History of Changes
Other Study ID Numbers: 2006-32
First Submitted: December 18, 2007
First Posted: December 20, 2007
Results First Submitted: April 19, 2011
Results First Posted: May 13, 2011
Last Update Posted: November 20, 2017