DT PACE, Tandem Autologous Transplant, Maintenance Therapy for Waldenstrom's Macroglobulinemia Patients

This study has been terminated.
(Terminated due to poor accrual.)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00107614
First received: April 5, 2005
Last updated: August 24, 2011
Last verified: August 2011
Results First Received: April 15, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Waldenstrom Macroglobulinemia
Intervention: Drug: DT PACE + Rituxan

  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
Waldenstrom's Macroglobulinemia Patients Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:

Participant Flow:   Overall Study
    Waldenstrom's Macroglobulinemia Patients  
STARTED     12  
COMPLETED     0  
NOT COMPLETED     12  
Physician Decision                 10  
Death                 2  



  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
Waldenstrom's Macroglobulinemia Patients Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:

Baseline Measures
    Waldenstrom's Macroglobulinemia Patients  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     6  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 11.0  
Gender  
[units: participants]
 
Female     4  
Male     8  



  Outcome Measures

1.  Primary:   Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)   [ Time Frame: 3 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
Early termination due to small numbers of subjects enrolled. Only one participant completed the study. Other participants came off study due to death, toxicity, physician choice, or patient choice.


  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


No publications provided


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00107614     History of Changes
Other Study ID Numbers: UARK 2002-10
Study First Received: April 5, 2005
Results First Received: April 15, 2011
Last Updated: August 24, 2011
Health Authority: United States: Institutional Review Board