DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation

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. Identifier: NCT00083915
Recruitment Status : Completed
First Posted : June 4, 2004
Results First Posted : August 3, 2011
Last Update Posted : November 20, 2017
Information provided by (Responsible Party):
University of Arkansas

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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

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]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      27  51.9%      24  53.3%      51  52.6% 
>=65 years      25  48.1%      21  46.7%      46  47.4% 
[Units: Years]
Mean (Standard Deviation)
 64.83  (8.77)   65.5  (8.36)   65.14  (8.55) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      22  42.3%      19  42.2%      41  42.3% 
Male      30  57.7%      26  57.8%      56  57.7% 

  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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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: University of Arkansas Identifier: NCT00083915     History of Changes
Other Study ID Numbers: UARK 2001-12
First Submitted: June 3, 2004
First Posted: June 4, 2004
Results First Submitted: July 7, 2011
Results First Posted: August 3, 2011
Last Update Posted: November 20, 2017