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Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy

This study has been completed.
Sponsor:
Collaborators:
Millennium Pharmaceuticals, Inc.
Cephalon
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01056276
First received: January 22, 2010
Last updated: March 30, 2017
Last verified: March 2017
Results First Received: February 8, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Bendamustine
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
Between May 2010 and May 2014, 59 patients with transplant-ineligible Multiple Myeloma (MM) were enrolled at 9 investigational sites in the U.S. The original treatment plan was modified during the trial to decrease intensity but increase treatment duration. Of 59 enrolled patients, 18 were treated on the initial regimen; 41 on the modified plan.

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
Original BBD Regimen

Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.

Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4

Modified BBD Regimen

Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.

Treatment:

Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16

Maintenance:

Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15


Participant Flow for 2 periods

Period 1:   Treatment Period-Cycles 1-8
    Original BBD Regimen   Modified BBD Regimen
STARTED   18   41 
COMPLETED   5   33 
NOT COMPLETED   13   8 
Toxicity                2                1 
Withdrawal by Subject                1                2 
Disease Progression                2                2 
Intercurrent Illness                1                2 
Physician Decision                3                0 
Death                3                1 
Lost to Follow-up                1                0 

Period 2:   Maintenance Therapy
    Original BBD Regimen   Modified BBD Regimen
STARTED   0 [1]   28 [2] 
COMPLETED   0   0 [3] 
NOT COMPLETED   0   28 
Toxicity                0                2 
Progressive Disease                0                9 
Physician Decision                0                1 
Withdrawal by Subject                0                1 
Intercurrent Illness                0                1 
Continuing maintenance therapy                0                14 
[1] Original regimen did not include maintenance therapy.
[2] 5 patients completed 8 cycles but did not have maintenance therapy.
[3] 14 patients are continuing maintenance therapy.



  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.
All patients enrolled in either the original treatment regimen or the modified treatment regimen.

Reporting Groups
  Description
Original BBD Regimen

Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.

Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4

Modified BBD Regimen

Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.

Treatment:

Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16

Maintenance:

Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15

Total Total of all reporting groups

Baseline Measures
   Original BBD Regimen   Modified BBD Regimen   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   41   59 
Age 
[Units: Years]
Median (Full Range)
 75 
 (55 to 81) 
 75 
 (45 to 89) 
 75 
 (45 to 89) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
     
female      5  27.8%      14  34.1%      19  32.2% 
male      13  72.2%      26  63.4%      39  66.1% 
unknown      0   0.0%      1   2.4%      1   1.7% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
American Indian/Alaskan Native   0   1   1 
Asian   1   0   1 
Black/African American   3   10   13 
Caucasian   14   27   41 
White   0   2   2 
Unknown   0   1   1 
Region of Enrollment 
[Units: Participants]
     
United States   18   41   59 


  Outcome Measures
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1.  Primary:   Complete Response Rate   [ Time Frame: every 8 weeks for approximately 48 months ]

2.  Primary:   Number of Patients Who Experienced Serious and Non-serious Adverse Events   [ Time Frame: approximately 36 weeks ]

3.  Secondary:   Progression Free Survival   [ Time Frame: every 8 weeks for up to 48 months ]

4.  Secondary:   Overall Survival   [ Time Frame: every 4 weeks until progressive disease then every 12 weeks, projected 48 months ]

5.  Secondary:   Overall Response Rate   [ Time Frame: every 4 weeks for approximately 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Charles Davis, RAC
Organization: Sarah Cannon Development Innovations
e-mail: charles.davis2@scri-innovations.com



Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01056276     History of Changes
Other Study ID Numbers: SCRI MM 23
Study First Received: January 22, 2010
Results First Received: February 8, 2017
Last Updated: March 30, 2017