S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

This study has been terminated.
(poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00124579
First received: July 26, 2005
Last updated: March 8, 2013
Last verified: March 2013
Results First Received: January 2, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: bortezomib
Drug: dexamethasone
Drug: thalidomide

  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
No text entered.

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
Bortezomib With Thalidomide and Dexamethasone Induction

Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).

Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.


Participant Flow for 2 periods

Period 1:   Induction
    Bortezomib With Thalidomide and Dexamethasone Induction  
STARTED     7  
COMPLETED     2  
NOT COMPLETED     5  

Period 2:   Maintenance
    Bortezomib With Thalidomide and Dexamethasone Induction  
STARTED     2  
COMPLETED     0  
NOT COMPLETED     2  



  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
Bortezomib With Thalidomide and Dexamethasone

Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).

Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.


Baseline Measures
    Bortezomib With Thalidomide and Dexamethasone  
Number of Participants  
[units: participants]
  7  
Age  
[units: years]
Median ( Full Range )
  63.7  
  ( 37.6 to 81.4 )  
Gender  
[units: participants]
 
Female     4  
Male     3  



  Outcome Measures
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1.  Primary:   Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).   [ Time Frame: 1 year ]

2.  Secondary:   Toxicity   [ Time Frame: From date of protocol therapy start to date of protocol therapy end. ]

3.  Secondary:   Progression-Free Survival   [ Time Frame: about 12-18 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
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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 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.


Results Point of Contact:  
Name/Title: Robert Z. Orlowski, MD, PhD
Organization: SWOG
phone: (713) 792-2860
e-mail: rorlowsk@mdanderson.org


No publications provided


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00124579     History of Changes
Other Study ID Numbers: CDR0000435925, S0417, U10CA032102
Study First Received: July 26, 2005
Results First Received: January 2, 2013
Last Updated: March 8, 2013
Health Authority: United States: Federal Government