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Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903968
First Posted: May 19, 2009
Last Update Posted: September 29, 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.
Collaborators:
Brigham and Women's Hospital
Genzyme, a Sanofi Company
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute
Results First Submitted: August 31, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Plerixafor
Drug: bortezomib
Drug: Dexamethasone

  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 in the Phase I study enrolled from June 2009 - July 2011 and the Phase II study from May 2012 - March 2015.

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
Phase I Dose Level 1 Phase I Dose Level 1 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 2 Phase I Dose Level 2 patients received plerixafor 160ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 3 Phase I Dose Level 3 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.0 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 4 Phase I Dose Level 4 patients received plerixafor 240ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 5 Phase I Dose Level 5 patients received plerixafor 320ug/kg by injection on days 1-6 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 5B Phase I Dose Level 5B patients received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
Phase I Dose Level 6 Phase I Dose Level 6 patients received plerixafor 400ug/kg by injection on days 1, 2, 3, 6, 10, and 13 and bortezomib 1.3 mg/m2 intravenously days 3, 6, 10, and 13 of each 21 day cycle until disease progression or unacceptable toxicity.
All Phase II Participants All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Phase I Dose Level 1   Phase I Dose Level 2   Phase I Dose Level 3   Phase I Dose Level 4   Phase I Dose Level 5   Phase I Dose Level 5B   Phase I Dose Level 6   All Phase II Participants
STARTED   3   3   3   3   4   6   3   33 
COMPLETED   0   0   0   0   0   0   0   0 
NOT COMPLETED   3   3   3   3   4   6   3   33 
Adverse Event                0                0                0                0                0                0                1                8 
DLT                0                0                0                0                0                0                2                0 
Withdrawal by Subject                1                0                1                0                1                1                0                4 
Non-Compliance                0                0                0                0                0                1                0                0 
Physician Decision                0                0                0                0                0                1                0                0 
Progressive Disease                2                3                2                3                3                3                0                18 
Lack of Efficacy                0                0                0                0                0                0                0                3 



  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
All Phase I Particiapnts All Phase I participants received plerixafor by injection and bortezomib intravenously according to the established dose escalation schedule. Participants were treated until disease progression or unacceptable toxicity.
All Phase II Participants All Phase II participants received plerixafor 320ug/kg by injection on days 1, 2, 3, 6, 10, and 13, bortezomib 1.3 mg/m2 intravenously or subcutaneously days 3, 6, 10, and 13, and dexamethasone 40mg orally days 3, 6, 10, and 13 of each 21 day cycle during induction. In maintenance, participants received plerixafor, bortezomib, and dexamethasone days 1, 8, 15, and 22 of each 35 day cycle. Participants were treated until disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   All Phase I Particiapnts   All Phase II Participants   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   33   58 
Age 
[Units: Years]
Median (Full Range)
 59 
 (43 to 85) 
 63 
 (46 to 83) 
 63 
 (43 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  44.0%      9  27.3%      20  34.5% 
Male      14  56.0%      24  72.7%      38  65.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1   3.0%      1   1.7% 
Not Hispanic or Latino      25 100.0%      30  90.9%      55  94.8% 
Unknown or Not Reported      0   0.0%      2   6.1%      2   3.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   3.0%      1   1.7% 
Asian      0   0.0%      4  12.1%      4   6.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   8.0%      1   3.0%      3   5.2% 
White      22  88.0%      27  81.8%      49  84.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   4.0%      0   0.0%      1   1.7% 
Region of Enrollment 
[Units: Participants]
     
United States   25   33   58 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Plerixafor Maximum Tolerated Dose (MTD) [Phase I]   [ Time Frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment. ]

2.  Primary:   Bortezomib Maximum Tolerated Dose (MTD) [Phase I]   [ Time Frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment. ]

3.  Primary:   Dose Limiting Toxicity (DLT) [Phase I]   [ Time Frame: Participants were assessed every 3 weeks while on study; The observation period for MTD evaluation was the first 21 days of treatment. ]

4.  Primary:   Response Rate of Plerixafor, Bortezomib, and Dexamethasone in Relapsed or Relapsed/ Refractory Multiple Myeloma (ORR) [Phase II]   [ Time Frame: Disease was assessed for response every cycle on treatment. ]

5.  Secondary:   Time to Progression (TTP) [Phase II]   [ Time Frame: DIsease was assessedto document progression every cycle on treatment and post-treatment every 12 weeks until progression. ]

6.  Secondary:   Duration of Response (DOR) [Phase II]   [ Time Frame: DIsease was assessed to document response every cycle on treatment and post-treatment every 12 weeks until progression. ]


  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
No text entered.


  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: Irene M. Ghobrial, MD
Organization: Dana-Farber Cancer Institute
phone: 617-632-4198
e-mail: Irene_Ghobrial@dfci.harvard.edu



Responsible Party: Irene Ghobrial, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00903968     History of Changes
Other Study ID Numbers: 08-273
First Submitted: May 18, 2009
First Posted: May 19, 2009
Results First Submitted: August 31, 2017
Results First Posted: September 29, 2017
Last Update Posted: September 29, 2017