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Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma

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ClinicalTrials.gov Identifier: NCT01315873
Recruitment Status : Terminated (PI left the institution before all data analysis was completed)
First Posted : March 15, 2011
Results First Posted : December 8, 2017
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Bendamustine
Drug: Bortezomib
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bortezomib and Bendamustine
Hide Arm/Group Description

Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Bortezomib and Bendamustine
Hide Arm/Group Description

Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  20.8%
>=65 years
19
  79.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
10
  41.7%
Male
14
  58.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
 100.0%
1.Primary Outcome
Title Percent Change Response Rate (Partial Response or Better After 2 Cycles) Following Treatment With Bortezomib and Bendamustine
Hide Description These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life.The IWG criteria define 4 aspects of responses based on treatment goals: (1) altering the natural history of the disease, (2) cytogenetic response, (3) hematologic improvement (HI), and (4)Quality of Life (QOL)
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participant data was not analyzed because PI left institution
Arm/Group Title Bortezomib and Bendamustine
Hide Arm/Group Description:

Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Toxicity of This Regimen.
Hide Description Study toxicity will be measured on an ongoing basis, no less then once per 28-day cycle.
Time Frame Every 4 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Participant data was not analyzed because PI left institution. Data were not available for analysis.
Arm/Group Title Bortezomib and Bendamustine
Hide Arm/Group Description:

Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Duration of Response of This Regimen.
Hide Description Time from response to relapse. Response would have been assessed using European Group for Blood and Marrow Transplantation (EBMT) criteria modified to include near complete remission (nCR) and very good partial remission (VGPR
Time Frame from initial response to relapse, up to 100 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Participant data was not analyzed because PI left institution
Arm/Group Title Bortezomib and Bendamustine
Hide Arm/Group Description:

Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 8 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bortezomib and Bendamustine
Hide Arm/Group Description

Bendamustine: On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

Bortezomib: On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.

Patients will be treated until disease progression after at least one cycle of treatment.

All-Cause Mortality
Bortezomib and Bendamustine
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Bortezomib and Bendamustine
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bortezomib and Bendamustine
Affected / at Risk (%)
Total   0/24 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Michael Grossbard, MD
Organization: New York University School of Medicine
Phone: 646 501 9305
EMail: Michael.Grossbard@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01315873     History of Changes
Other Study ID Numbers: 10-02009
First Submitted: March 14, 2011
First Posted: March 15, 2011
Results First Submitted: August 17, 2017
Results First Posted: December 8, 2017
Last Update Posted: February 7, 2018