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Trial record 2 of 315 for:    BENDAMUSTINE

Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma (BVRD)

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ClinicalTrials.gov Identifier: NCT01484626
Recruitment Status : Terminated (Celgene would no longer supply lenalidomide for the study)
First Posted : December 2, 2011
Results First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Scott E Smith, MD, PhD, Loyola University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Intervention Drug: Bendamustine
Enrollment 3
Recruitment Details Participants were recruited from May 2011 through April 2014 (36 months) from the Cardinal Bernardin Cancer Center at Loyola University Medical Center
Pre-assignment Details There are no pre-assignment details to report
Arm/Group Title Bendamustine
Hide Arm/Group Description Bendamustine is combined with standard chemotherapy
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Bendamustine
Hide Arm/Group Description Bendamustine is combined with standard chemotherapy
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
The baseline analysis population comprises all participants who signed an informed consent document
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  66.7%
>=65 years
1
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  33.3%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Number of Patients Experiencing a Toxicity
Hide Description The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
No patients were analyzed as study was terminated early after external sponsor withdrew support. Therefore, data necessary for planned analyses were not collected.
Arm/Group Title Bendamustine
Hide Arm/Group Description:
Bendamustine is combined with standard chemotherapy
Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
Experienced no toxicities
0
   0.0%
Experienced at least one toxicity
3
 100.0%
Time Frame Adverse event data were collected from November 2011 through June 2014 (32 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bendamustine
Hide Arm/Group Description Bendamustine is combined with standard chemotherapy
All-Cause Mortality
Bendamustine
Affected / at Risk (%)
Total   0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bendamustine
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Blood and lymphatic system disorders   
Anemia *  1/3 (33.33%)  1
Thrombocytopenia *  1/3 (33.33%)  1
Neutropenia *  2/3 (66.67%)  2
Hypercalcemia *  1/3 (33.33%)  1
Endocrine disorders   
Arthritis *  1/3 (33.33%)  1
Gastrointestinal disorders   
Decreased appetite *  1/3 (33.33%)  1
Nausea *  1/3 (33.33%)  1
Infections and infestations   
Upper respiratory infection *  1/3 (33.33%)  1
Nervous system disorders   
Neuropathy *  1/3 (33.33%)  1
Psychiatric disorders   
Anxiety *  1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders   
Shortness of Breath on Exertion *  2/3 (66.67%)  2
*
Indicates events were collected by non-systematic assessment
The trial terminated in June 2014 when Celgene could no longer supply lenalidomide for the study
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Smith, M.D., Ph.D.
Organization: Loyola University Medical Center
Phone: 708-327-3142
EMail: ssmith8@lumc.edu
Publications:
Layout table for additonal information
Responsible Party: Scott E Smith, MD, PhD, Loyola University
ClinicalTrials.gov Identifier: NCT01484626     History of Changes
Other Study ID Numbers: 203145
First Submitted: November 28, 2011
First Posted: December 2, 2011
Results First Submitted: June 15, 2018
Results First Posted: July 10, 2018
Last Update Posted: July 10, 2018