Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00581919
First received: December 19, 2007
Last updated: July 14, 2016
Last verified: July 2016
Results First Received: July 14, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: Bort, Dex, and Dox with ALCAR

  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
Participants were recruited from University of Wisconsin Hospital and Clinics and the Wisconsin Oncology Network between April 2004 and September 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No events between enrollment and group assignment. All subjects are enrolled are assigned to the same group.

Reporting Groups
  Description
Bort, Dex, and Dox With ALCAR Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long

Participant Flow:   Overall Study
    Bort, Dex, and Dox With ALCAR  
STARTED     32  
COMPLETED     8  
NOT COMPLETED     24  
Adverse Event                 8  
Death                 1  
Disease Progression                 10  
Physician Decision                 1  
Other Complicating Disease                 1  
Started Non-Protocol Therapy                 2  
Withdrawal by Subject                 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.
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Reporting Groups
  Description
Bort, Dex, and Dox With ALCAR Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long

Baseline Measures
    Bort, Dex, and Dox With ALCAR  
Number of Participants  
[units: participants]
  32  
Age, Customized  
[units: participants]
 
30-39     1  
40-49     4  
50-59     6  
60-69     12  
70-79     7  
80-89     2  
Gender  
[units: participants]
 
Female     11  
Male     21  



  Outcome Measures
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1.  Primary:   Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bortezomib, Dexamethasone, Doxorubicin, and ALCAR   [ Time Frame: each cycle ]

2.  Secondary:   Overall Survival   [ Time Frame: Off Study ]

3.  Secondary:   Progression-free Survival   [ Time Frame: End of Study ]


  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: Dr. Natalie Callander
Organization: University of Wisconsin Hospital and Clinics
phone: 608-265-8690
e-mail: nsc@medicine.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00581919     History of Changes
Other Study ID Numbers: HO04402
Study First Received: December 19, 2007
Results First Received: July 14, 2016
Last Updated: July 14, 2016
Health Authority: United States: Institutional Review Board