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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;   Endpoint Classification: Safety/Efficacy Study;   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.
No text entered.

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  
Number of Participants  
[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.   Safety Issue:   No

  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
Health Authority: United States: Food and Drug Administration