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Bevacizumab, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Stage II or III Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00410605
First Posted: December 13, 2006
Last Update Posted: September 1, 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):
National Cancer Institute (NCI)
Results First Submitted: June 13, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Multiple Myeloma in Relapse
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Interventions: Biological: bevacizumab
Drug: lenalidomide
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 were recruited from the University of Wisconsin (UW) Hospital and Clinics, the UW 1 South Park Clinic, and the Wisconsin Oncology Network (WON) clinics between November 2006 and March 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No events between enrollment and group assignment. All subjects enrolled are immediately assigned to Arm 1, "Bevacizumab, Dexamethasone, and Lenalidomide."

Reporting Groups
  Description
Bevacizumab, Dexamethasone, and Lenalidomide

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

lenalidomide: Given orally

dexamethasone: Given orally


Participant Flow:   Overall Study
    Bevacizumab, Dexamethasone, and Lenalidomide
STARTED   39 
COMPLETED   14 
NOT COMPLETED   25 
Adverse Event                12 
Physician Decision                3 
Withdrawal by Subject                5 
Started Non-Protocol Therapy                3 
Stopped treatmen to collect stem cells                1 
Transferred to another Institution                1 



  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
Bevacizumab, Dexamethasone, and Lenalidomide

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15, oral lenalidomide on days 1-21, and oral dexamethasone on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

bevacizumab: Given IV

lenalidomide: Given orally

dexamethasone: Given orally


Baseline Measures
   Bevacizumab, Dexamethasone, and Lenalidomide 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age, Customized 
[Units: Participants]
 
40-49 years   2 
50-59 years   4 
60-69 years   15 
70-79 years   15 
80-89 years   3 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  38.5% 
Male      24  61.5% 
Region of Enrollment 
[Units: Participants]
 
United States   39 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Confirmed Anti-tumor Response Rate (Complete Response and Partial Response) to the Combination of Bevacizumab and Lenalidomide   [ Time Frame: Up to 5 years ]

2.  Primary:   Progression Free Survival (Time to Progression)   [ Time Frame: up to five years ]

3.  Secondary:   Toxicity and Tolerability of the Bevacizumab and Lenalidomide Combination   [ Time Frame: Up to 5 years ]

4.  Secondary:   Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at Baseline   [ Time Frame: Baseline ]

5.  Secondary:   Local Cytokine Milieu Using Tissue Micro Arrays of Bone Marrow Biopsy Specimens   [ Time Frame: Up to 5 years ]

6.  Secondary:   Effect of Bev/Rev on Markers of Myeloma Activity in Myeloma Cells and Stromal Cells at 3 Months Post-baseline   [ Time Frame: Up to Course 4 Day 1 (3 Months Post-baseline) ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Natalie Callander
Organization: Univerisity of Wisconsin Carbone Cancer Center
phone: 608-265-8690
e-mail: nsc@medicine.wisc.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00410605     History of Changes
Obsolete Identifiers: NCT00406328
Other Study ID Numbers: NCI-2009-00150
NCI-2009-00150 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
H-2006-0269 ( Other Identifier: UW Health Sciences IRB )
CDR0000521546
HO06401 ( Other Identifier: University of Wisconsin Hospital and Clinics )
7313 ( Other Identifier: CTEP )
U01CA062491 ( U.S. NIH Grant/Contract )
P30CA014520 ( U.S. NIH Grant/Contract )
First Submitted: December 11, 2006
First Posted: December 13, 2006
Results First Submitted: June 13, 2016
Results First Posted: September 1, 2017
Last Update Posted: September 1, 2017