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Bortezomib in Treating Patients With Newly Diagnosed Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00075881
First Posted: January 13, 2004
Last Update Posted: June 2, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: March 8, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Interventions: Drug: bortezomib
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
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 
Overall Participants Analyzed 
[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


  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:  
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: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075881     History of Changes
Other Study ID Numbers: NCI-2014-00652
NCI-2014-00652 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000349450
E2A02 ( Other Identifier: Eastern Cooperative Oncology Group )
E2A02 ( Other Identifier: CTEP )
U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2004
First Posted: January 13, 2004
Results First Submitted: March 8, 2012
Results First Posted: September 28, 2012
Last Update Posted: June 2, 2014