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UARK 89-001 Phase II Study of Intensive "TOTAL THERAPY" For Untreated or Minimally Treated Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00580372
First received: December 18, 2007
Last updated: August 1, 2016
Last verified: August 2016
Results First Received: August 1, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: VAD
Drug: High-Dose cyclophosphamide
Procedure: Hemopoietic stem cell procurement
Drug: EDAP
Procedure: Autologous Hemopoietic Stem Cell Transplant 1
Procedure: Autologous Hemopoietic Stem Cell Transplant 2
Drug: Maintenance

  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
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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
  Description
Study Treatment

Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.

VAD: 3 Cycles (3rd cycle optional):

Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20

High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:

Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1

Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg

EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide


Participant Flow:   Overall Study
    Study Treatment  
STARTED     231  
COMPLETED     231  
NOT COMPLETED     0  



  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
Study Treatment

Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.

VAD: 3 Cycles (3rd cycle optional):

Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20

High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:

Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1

Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg

EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide


Baseline Measures
    Study Treatment  
Number of Participants  
[units: participants]
  231  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     211  
>=65 years     20  
Age  
[units: years]
Median (Full Range)
  51.6  
  (26.5 to 71.5)  
Gender  
[units: participants]
 
Female     91  
Male     140  
Region of Enrollment  
[units: participants]
 
United States     231  



  Outcome Measures

1.  Primary:   Percentage of Participants That Are Relapse-free 5 Years After Initial Therapy   [ Time Frame: 5 years ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Bart Barlogie
Organization: University of Arkansas for Medical Science
phone: 501-526-2873



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00580372     History of Changes
Other Study ID Numbers: 01332
Study First Received: December 18, 2007
Results First Received: August 1, 2016
Last Updated: August 1, 2016
Health Authority: United States: Institutional Review Board