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DTPACE Followed by Tandem Transplant With MEL 200 Versus MEL/DTPACE Hybrid and DTPACE Consolidation

This study has been completed.
Information provided by:
University of Arkansas Identifier:
First received: June 3, 2004
Last updated: July 7, 2011
Last verified: July 2011
Results First Received: July 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Adriamycin
Drug: Etoposide
Drug: Melphalan
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
High Dose Melphalan No text entered.
Mel-DT PACE No text entered.

Participant Flow:   Overall Study
    High Dose Melphalan   Mel-DT PACE
STARTED   52   45 
COMPLETED   2   8 
NOT COMPLETED   50   37 
Death                6                3 
Physician Decision                11                6 
Withdrawal by Subject                8                3 
disease progression                18                23 
Failure to collect                3                0 
No response                3                1 
Insurance issues                1                1 

  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.
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Reporting Groups
High Dose Melphalan No text entered.
Mel-DT PACE No text entered.
Total Total of all reporting groups

Baseline Measures
   High Dose Melphalan   Mel-DT PACE   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   45   97 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   27   24   51 
>=65 years   25   21   46 
[Units: Years]
Mean (Standard Deviation)
 64.83  (8.77)   65.5  (8.36)   65.14  (8.55) 
[Units: Participants]
Female   22   19   41 
Male   30   26   56 

  Outcome Measures

1.  Primary:   Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone.   [ Time Frame: 3 years depending on start date ]

2.  Secondary:   Side Effects With DT PACE-Melphalan vs Side Effects With Melphalan Alone   [ Time Frame: 3 years depending on start date ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  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

Responsible Party: Nathan Petty, MS, University_Of_Arkansas Identifier: NCT00083915     History of Changes
Other Study ID Numbers: UARK 2001-12
Study First Received: June 3, 2004
Results First Received: July 7, 2011
Last Updated: July 7, 2011