Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia

This study has been terminated.
(funding was withdrawn)
Sponsor:
Collaborators:
National Cancer Institute (NCI)
GlaxoSmithKline
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01536067
First received: February 10, 2012
Last updated: May 3, 2016
Last verified: May 2016
Results First Received: May 3, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Waldenström Macroglobulinemia
Interventions: Biological: ofatumumab
Drug: bortezomib
Other: laboratory biomarker analysis

  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
No text entered.

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
Treatment (Monoclonal Antibody Therapy)

INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

ofatumumab: Given IV

bortezomib: Given SC

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Monoclonal Antibody Therapy)  
STARTED     3  
COMPLETED     2  
NOT COMPLETED     1  
Disease Progression                 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.
All treated and eligible patients

Reporting Groups
  Description
Treatment (Monoclonal Antibody Therapy)

INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

ofatumumab: Given IV

bortezomib: Given SC

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Treatment (Monoclonal Antibody Therapy)  
Number of Participants  
[units: participants]
  3  
Age  
[units: years]
Mean (Standard Deviation)
  62.5  (1.8)  
Gender  
[units: participants]
 
Female     0  
Male     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate (CR + PR + MR) of Ofatumumab in Combination With Bortezomib   [ Time Frame: Every 28 days ]

2.  Secondary:   Frequency of Near (n)CR   [ Time Frame: Every 28 days ]

3.  Secondary:   Frequency of Very Good Partial Response (VGPR)   [ Time Frame: Every 28 days ]

4.  Secondary:   Frequency of PR   [ Time Frame: Every 28 days ]

5.  Secondary:   Time to Progression   [ Time Frame: From start of treatment to disease progression, assessed up to 12 months ]

6.  Secondary:   Progression-free Survival   [ Time Frame: From start of treatment to disease progression or death (regardless of the cause of death), whichever comes first, assessed up to 12 months ]

7.  Secondary:   Duration of Response   [ Time Frame: From the observation of a response to the time of disease progression, assessed up to 12 months ]

8.  Secondary:   Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0   [ Time Frame: Every 30 days for 2 months ]

9.  Secondary:   Frequency of Complete Remission (CR)   [ Time Frame: Every 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
phone: 716-845-2300



Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01536067     History of Changes
Other Study ID Numbers: I 205011
NCI-2011-03816 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: February 10, 2012
Results First Received: May 3, 2016
Last Updated: May 3, 2016
Health Authority: United States: Food and Drug Administration