UARK 2009-09 Myeloma Cure Project: Prospective Trial of Indefinite Revlimid Maintenance Versus Observation for Currently Event-Free Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01621672
First received: May 31, 2012
Last updated: September 29, 2015
Last verified: September 2015
Results First Received: August 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: Revlimid

  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
Revlimid Revlimid: 10 mg/day in the morning same time each day
Observation No treatment

Participant Flow:   Overall Study
    Revlimid     Observation  
STARTED     25     17  
COMPLETED     25     17  
NOT COMPLETED     0     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.
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Reporting Groups
  Description
Revlimid Revlimid: 10 mg/day in the morning same time each day
Observation No treatment
Total Total of all reporting groups

Baseline Measures
    Revlimid     Observation     Total  
Number of Participants  
[units: participants]
  25     17     42  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     11     25  
>=65 years     11     6     17  
Gender  
[units: participants]
     
Female     9     5     14  
Male     16     12     28  
Race/Ethnicity, Customized  
[units: participants]
     
White     24     17     41  
Other     1     0     1  



  Outcome Measures

1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 2 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bart Barlogie
Organization: University of Arkansas for Medical Sciences
phone: 526-6990 ext 2420
e-mail: barlogiebart@uams.edu



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01621672     History of Changes
Other Study ID Numbers: 110468
Study First Received: May 31, 2012
Results First Received: August 12, 2015
Last Updated: September 29, 2015
Health Authority: United States: Institutional Review Board