Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00099047
First received: December 8, 2004
Last updated: June 4, 2015
Last verified: October 2013
Results First Received: December 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Monoclonal Gammopathy of Undetermined Significance
Multiple Myeloma
Smoldering Multiple Myeloma
Interventions: Drug: celecoxib
Drug: placebo
Other: laboratory biomarker analysis

  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
23 asymptomatic adult patients with a serum monoclonal protein >1g/dL from Cleveland Clinic, Mayo Clinic, or University of Arkansas Medical Center were randomized between August 2005 and April 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were no significant events or approaches utilized following enrollment but prior to group assignment.

Reporting Groups
  Description
Arm I (Celecoxib) Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Arm II (Placebo) Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.

Participant Flow:   Overall Study
    Arm I (Celecoxib)     Arm II (Placebo)  
STARTED     11     12  
COMPLETED     11     12  
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.
Asymptomatic adult patients with a serum monoclonal protein >1g/dL from each of the participating centers between August 2005 and April 2008 were randomized to either celecoxib or placebo in a double-blind, 1:1 fashion

Reporting Groups
  Description
Arm I (Celecoxib) Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Arm II (Placebo) Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Total Total of all reporting groups

Baseline Measures
    Arm I (Celecoxib)     Arm II (Placebo)     Total  
Number of Participants  
[units: participants]
  11     12     23  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     9     17  
>=65 years     3     3     6  
Gender  
[units: participants]
     
Female     5     4     9  
Male     6     8     14  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     10     12     22  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     1     1  
White     11     11     22  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     11     12     23  
serum monoclonal protein >1g/dL  
[units: participants]
  11     12     23  



  Outcome Measures

1.  Primary:   Changes in M-protein Levels   [ Time Frame: Baseline and 6 months ]


  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
No overall limitations or caveats for this trial.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Matt Kalaycio, MD
Organization: Cleveland Clinic
phone: 216-444-3705
e-mail: kalaycm@ccf.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00099047     History of Changes
Other Study ID Numbers: NCI-2009-00866, NCI-2009-00866, CDR0000393514, UARK-18697, MAYO-206904, CCF-IRB-7029, N01-CN-25140, N01CN25140
Study First Received: December 8, 2004
Results First Received: December 16, 2014
Last Updated: June 4, 2015
Health Authority: United States: Food and Drug Administration
United States: Federal Government