Bortezomib in Treating Patients With Newly Diagnosed High-Risk Stage III Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075881
First received: January 9, 2004
Last updated: November 27, 2012
Last verified: October 2012
Results First Received: March 8, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Plasma Cell Neoplasm
Intervention: Drug: PS-341

  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
The study was activated on January 16, 2004 and terminated on March 7, 2005 after 44 patients had enrolled. Accrual rate was 3 patients per month, slower than expected rate (6 patients per month)

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
PS-341

Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.

Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.

Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.


Participant Flow:   Overall Study
    PS-341  
STARTED     44  
Eligible     43  
Treated     42  
Induction Treatment     42  
Maintenance Treatment     15  
Reinduction Treatment     7  
COMPLETED     1  
NOT COMPLETED     43  
Lack of Efficacy                 18  
Adverse Event                 7  
Death                 1  
Withdrawal by Subject                 2  
Protocol Violation                 4  
other complicating disease                 3  
other                 4  
missing data                 2  
Ineligible                 1  
never start protocol therapy                 1  



  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
PS-341

Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.

Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.

Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.


Baseline Measures
    PS-341  
Number of Participants  
[units: participants]
  42  
Age  
[units: years]
Median ( Full Range )
  63  
  ( 44 to 81 )  
Gender  
[units: participants]
 
Female     21  
Male     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Response Rate on Induction   [ Time Frame: participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days ]

2.  Secondary:   Response Rate on Maintenance   [ Time Frame: participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days ]

3.  Secondary:   Response Rate on Reinduction   [ Time Frame: participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days ]

4.  Secondary:   1-year Progression Free Survival Probability   [ Time Frame: Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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 text entered.  


Results Point of Contact:  
Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012


Publications of Results:
Dispenzieri A, Zhang L, Fonseca R, et al.: Single agent bortezomib is associated with a high response rate in patients with high risk myeloma. A phase II study from the Eastern Cooperative Oncology Group (E2A02). [Abstract] Blood 108 (11): A-3527, 2006.


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075881     History of Changes
Other Study ID Numbers: CDR0000349450, U10CA021115, E2A02
Study First Received: January 9, 2004
Results First Received: March 8, 2012
Last Updated: November 27, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration