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Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461045
First Posted: April 17, 2007
Last Update Posted: September 13, 2017
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):
Triphase Research and Development I Corporation
Results First Submitted: March 29, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: MRZ 0.5 mg/m^2

  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
MRZ 0.5 mg/m^2 Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles

Participant Flow:   Overall Study
    MRZ 0.5 mg/m^2
STARTED   15 
COMPLETED   15 
NOT COMPLETED   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
MRZ 0.5 mg/m^2 Twice-weekly dosing with 2-hour IV infusions on days 1,4,8, and 11 of 3-week cycles

Baseline Measures
   MRZ 0.5 mg/m^2 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.9  (8.02) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  33.3% 
Male      10  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      15 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2  13.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      3  20.0% 
White      10  66.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   15 
Baseline Height 
[Units: Cm]
Mean (Standard Deviation)
 170.97  (12.152) 
Baseline Weight 
[Units: Kg]
Mean (Standard Deviation)
 77.27  (17.825) 
Body Surface Area (BSA) 
[Units: M^2]
Mean (Standard Deviation)
 1.893  (0.2629) 
Fertility Status 
[Units: Participants]
Count of Participants
 
Potential able to bear children      0   0.0% 
Surgically sterile      1   6.7% 
Post menopausal      4  26.7% 
Male      10  66.7% 
Karnofsky Performance Status (KPS) Score [1] 
[Units: KPS Score]
Mean (Full Range)
 87.3 
 (70.0 to 100.0) 
[1] KPS Score: 100=Normal, no complaints; 90=Able to carry on normal activity, minor signs or symptoms of disease; 80=Normal activity with effort; 70= Unable to carry on normal activity or perform active work, cares for self.
Time Since Initial Diagnosis 
[Units: Years]
Mean (Standard Deviation)
 5.2  (3.79) 
Number of Relapses 
[Units: Participants]
 
1 Relapse   0 
2 Relapses   2 
3 Relapses   2 
>3 Relapses   11 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Exhibiting a Given Overall Response as Determined by Investigator   [ Time Frame: Through study completion, an average of 6.09 weeks. ]

2.  Secondary:   Duration of MRZ Treatment   [ Time Frame: Through study completion, an average of 6.09 weeks. ]

3.  Secondary:   Number of Cycles of Marizomib (MRZ)   [ Time Frame: Through study completion, an average of 6.09 weeks. ]

4.  Secondary:   Number of Patients Receiving Marizomib (MRZ) in Each Cycle   [ Time Frame: Through study completion, an average of 6.09 weeks. ]

5.  Secondary:   Number of Patients With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Through study completion, an average of 6.09 weeks. ]

6.  Secondary:   Number of Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: Through study completion, an average of 6.09 weeks. ]

7.  Secondary:   Maximum Observed Blood Drug Concentration (Cmax)   [ Time Frame: Samples collected on Cycle 1 Day 1 and Cycle 1 Day 11. ]


  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: Associate Director of Clinical and Regulatory Operations
Organization: Triphase Accelerator
phone: 858-295-4337
e-mail: jennifer.ki@triphaseco.com


Publications:
Cheson BD, Pfistner B, Juweid ME, et al. Revised Response Criteria for Malignant Lymphomas. From the Members of the International Harmonization Project (IHP) of the Competence Network Malignant Lymphoma, 47th Annual Meeting of the American Society of Hematology. Blood. 2005 Nov;106: abstract #18
ClinicalTrials.gov. Phase 3 Study With Carfilzomib and Dexamethasone Versus Velcade and Dexamethasone for Relapsed Multiple Myeloma Patients (ENDEAVOR). ClinicalTrials.gov Identifier: NCT01568866.
12. Facon T, Dimopoulos M, Dispenzieri A, et al. Initial Phase 3 Results Of The First (Frontline Investigation Of Lenalidomide + Dexamethasone Versus Standard Thalidomide) Trial (MM-020/IFM 07 01) In Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Ineligible For Stem Cell Transplantation (SCT). 2013; ASH Annual Meeting Plenary Session, Sunday, December 8, 2013: 2:55 PM
KYPROLIS™ (carfilzomib) for Injection Prescribing Information. Onyx Pharmaceuticals, Inc., South San Francisco, CA; 07/2012. http://www.kyprolis.com/Areas/Hcp/content/pdfs/PI.pdf
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. http://www.cap.org/apps/docs/committees/immunology/myeloma.pdf. Multiple Myeloma (V.1.2011), 201. Accessed 20 September 2013
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. http://www.nccn.org/professionals/physician_gls/pdf/myeloma.pdf. Multiple Myeloma (Version 2.2013). Accessed 29 August 2013
Suzuki E, Jazirehi A, Palladino M, Bonavida B. Chemosensitization of Drug and Rituximab Resistant Daudi B-NHL Clones to Drug-Induced Apoptosis by the Proteasome Inhibitor NPI-0052. 47th Annual Meeting of the American Society for Hematology. Blood. 2005;106: abstract #1521

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Triphase Research and Development I Corporation
ClinicalTrials.gov Identifier: NCT00461045     History of Changes
Other Study ID Numbers: NPI-0052-101
First Submitted: April 13, 2007
First Posted: April 17, 2007
Results First Submitted: March 29, 2017
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017