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Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma

This study has been terminated.
(study terminated due to low accrual)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00128921
First received: August 8, 2005
Last updated: April 25, 2012
Last verified: April 2012
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: Prevention
Condition: Multiple Myeloma
Intervention: Drug: VELCADE™

  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
Recruitment was between 4/17/2006 to 11/26/2007. The Recruitment occurred in the Myeloma outpatient clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment plan was as follows: The first 10 were enrolled in Arm A, the next 10 were enrolled in Arm B and the last 10 were to be enrolled in Arm C. 10 participants were enrolled on Arm A, 8 participants on Arm B and 0 on Arm C. Of the 8 participants in Arm B, only 6 were analyzed because 2 withdrew before receiving bortezomib.

Reporting Groups
  Description
Bortezomib, Cohort a treatment: 1.3 mg/m^2
Bortezomib, Cohort b treatment: 1.0 mg/m^2
Bortezomib, Cohort c treatment: 0.7 mg/m^2

Participant Flow:   Overall Study
    Bortezomib, Cohort a     Bortezomib, Cohort b     Bortezomib, Cohort c  
STARTED     10     8     0  
Received Bortezomib     10     6     0  
COMPLETED     5     3     0  
NOT COMPLETED     5     5     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
Bortezomib, Cohort a treatment: 1.3 mg/m^2
Bortezomib, Cohort b treatment: 1.0 mg/m^2
Bortezomib, Cohort c treatment: 0.7 mg/m^2
Total Total of all reporting groups

Baseline Measures
    Bortezomib, Cohort a     Bortezomib, Cohort b     Bortezomib, Cohort c     Total  
Number of Participants  
[units: participants]
  10     8     0     18  
Age  
[units: participants]
       
<=18 years     0     0         0  
Between 18 and 65 years     6     3         9  
>=65 years     4     5         9  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 8.78     70.75  ± 8.69         67.55  ± 8.98  
Gender  
[units: participants]
       
Female     5     4         9  
Male     5     4         9  
Region of Enrollment  
[units: participants]
       
United States     10     8         18  



  Outcome Measures
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1.  Primary:   Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone   [ Time Frame: 6 months ]

2.  Primary:   Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Calcium   [ Time Frame: 6 months ]

3.  Primary:   Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Alkaline Phosphatase   [ Time Frame: 6 months ]

4.  Primary:   Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Magnesium   [ Time Frame: 6 months ]

5.  Primary:   Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Phosphate.   [ Time Frame: 6 months ]

6.  Secondary:   Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Osteocalcin   [ Time Frame: 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
Early termination due to difficulty in accruing participants.


  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: NCT00128921     History of Changes
Other Study ID Numbers: UARK 2004-22
Study First Received: August 8, 2005
Results First Received: April 15, 2011
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board