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Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01034553
First received: December 16, 2009
Last updated: April 18, 2016
Last verified: February 2016
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Refractory Multiple Myeloma
Interventions: Drug: Aurora A kinase inhibitor MLN8237
Drug: bortezomib

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Phase I, Dose 0**

Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.

Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV

Phase I, Dose 0

Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.

Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV

Phase I, Dose 1

Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.

Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV

Phase I, Dose 2

Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.

Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV

Phase I, Dose 3

Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.

Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV

Phase II, Dose 3

Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.

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> Aurora A kinase inhibitor MLN8237: Given orally

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> bortezomib: Given IV


Participant Flow:   Overall Study
    Phase I, Dose 0**     Phase I, Dose 0     Phase I, Dose 1     Phase I, Dose 2     Phase I, Dose 3     Phase II, Dose 3  
STARTED     3     4     3     3     6     7  
COMPLETED     3     4     3     3     6     7  
NOT COMPLETED     0     0     0     0     0     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.
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Reporting Groups
  Description
All Patients

All Patients that received oral aurora A kinase inhibitor MLN8237 and bortezomib IV are summarized in this section.

Aurora A kinase inhibitor MLN8237: Given orally


Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  26  
Age  
[units: years]
Median (Full Range)
  64.5  
  (46 to 79)  
Gender  
[units: participants]
 
Female     10  
Male     16  
Region of Enrollment  
[units: participants]
 
United States     26  
Previous treatment [1]
[units: participants]
  26  
[1] Previous treatment for this study is defined as any prior therapy given to the patient for treatment of Myeloma.



  Outcome Measures
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1.  Primary:   Dose-limiting Toxicity (DLT) (Phase I)   [ Time Frame: 28 days ]

2.  Primary:   Overall Response Rate to the Combination of MLN8237 and Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma.   [ Time Frame: Every 28 day cycle(up to 10 cycles) ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years ]

4.  Secondary:   Overall Survival   [ Time Frame: Every 28 day cycle(up to 10 cycles) then follow-up for up to 2 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alexander Keith Stewart, M.B.CH.B
Organization: Mayo Clinic
phone: (480)301-4411
e-mail: stewart.keith@mayo.edu



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01034553     History of Changes
Other Study ID Numbers: MC088A
NCI-2009-01475 ( Registry Identifier: NCI-CTRP )
08-006317 ( Other Identifier: Mayo Clinic IRB )
X14003 ( Other Identifier: MPI Protocol )
MC088A ( Other Identifier: Mayo Clinic Cancer Center )
Study First Received: December 16, 2009
Results First Received: October 16, 2015
Last Updated: April 18, 2016
Health Authority: United States: Food and Drug Administration