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Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia

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ClinicalTrials.gov Identifier: NCT01536067
Recruitment Status : Terminated (funding was withdrawn)
First Posted : February 20, 2012
Results First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
GlaxoSmithKline
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Waldenström Macroglobulinemia
Interventions Biological: ofatumumab
Drug: bortezomib
Other: laboratory biomarker analysis
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
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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

Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Reason Not Completed
Disease Progression             1
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description

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

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
62.5  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
0
   0.0%
Male
3
 100.0%
1.Primary Outcome
Title Overall Response Rate (CR + PR + MR) of Ofatumumab in Combination With Bortezomib
Hide Description Assessed using the Consensus Panel recommendations from the Third International Workshop on Waldenstrom Macroglobulinemia.
Time Frame Every 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and low accrual, data were not collected for this assessment.
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Frequency of Complete Remission (CR)
Hide Description [Not Specified]
Time Frame Every 28 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Frequency of Near (n)CR
Hide Description [Not Specified]
Time Frame Every 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and low accrual, data were not collected for this assessment.
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Frequency of Very Good Partial Response (VGPR)
Hide Description [Not Specified]
Time Frame Every 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and low accrual, data were not collected for this assessment.
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Frequency of PR
Hide Description [Not Specified]
Time Frame Every 28 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and low accrual, data were not collected for this assessment.
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame From start of treatment to disease progression, assessed up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and low accrual, data were not collected for this assessment.
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and low accrual, data were not collected for this assessment.
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Duration of Response
Hide Description [Not Specified]
Time Frame From the observation of a response to the time of disease progression, assessed up to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the study's early termination and low accrual, data were not collected for this assessment.
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Frequency and Severity of Toxicity as Graded According to the Cancer Therapeutic Evaluation Program (CTEP) Common Toxicity Criteria (CTC) Version 4.0
Hide Description Maximum grade per participant of any AE.
Time Frame Every 30 days for 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
Grade 1 0
Grade 2 0
Grade 3 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Monoclonal Antibody Therapy)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Monoclonal Antibody Therapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Monoclonal Antibody Therapy)
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%
Treatment (Monoclonal Antibody Therapy)
Affected / at Risk (%) # Events
Total   3/3 (100.00%)    
Blood and lymphatic system disorders   
Lymphopenia   1/3 (33.33%)  1
Neutropenia   1/3 (33.33%)  2
Thrombocytopenia   1/3 (33.33%)  1
Eye disorders   
Iritis   1/3 (33.33%)  1
Vision blurred   1/3 (33.33%)  1
Gastrointestinal disorders   
Abdominal pain   1/3 (33.33%)  1
Constipation   1/3 (33.33%)  1
Dyspepsia   1/3 (33.33%)  1
Nausea   1/3 (33.33%)  1
Vomiting   1/3 (33.33%)  1
General disorders   
Chills   2/3 (66.67%)  2
Fatigue   1/3 (33.33%)  2
Gait disturbance   1/3 (33.33%)  1
Infusion site rash   1/3 (33.33%)  1
Injection site erythema   1/3 (33.33%)  1
Injection site joint redness   1/3 (33.33%)  1
Non-cardiac chest pain   1/3 (33.33%)  1
Pyrexia   1/3 (33.33%)  1
Infections and infestations   
Furuncle   1/3 (33.33%)  1
Upper respiratory tract infection   1/3 (33.33%)  1
Injury, poisoning and procedural complications   
Fall   1/3 (33.33%)  1
Infusion related reaction   2/3 (66.67%)  5
Procedural pain   1/3 (33.33%)  1
Thermal burn   1/3 (33.33%)  1
Investigations   
Lymphocyte count decreased   1/3 (33.33%)  4
Metabolism and nutrition disorders   
Hypercalcaemia   1/3 (33.33%)  1
Hyperglycaemia   1/3 (33.33%)  1
Hypernatraemia   1/3 (33.33%)  1
Hyperuricaemia   1/3 (33.33%)  1
Hypocalcaemia   1/3 (33.33%)  1
Hypoglycaemia   1/3 (33.33%)  3
Hyponatraemia   1/3 (33.33%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasms   1/3 (33.33%)  1
Muscular weakness   1/3 (33.33%)  1
Pain in extremity   1/3 (33.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour flare   1/3 (33.33%)  1
Nervous system disorders   
Dizziness   1/3 (33.33%)  2
Neuropathy peripheral   1/3 (33.33%)  1
Peroneal nerve palsy   1/3 (33.33%)  1
Presyncope   1/3 (33.33%)  1
Sensory loss   1/3 (33.33%)  1
Reproductive system and breast disorders   
Scrotal swelling   1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders   
Cough   1/3 (33.33%)  1
Skin and subcutaneous tissue disorders   
Acne   1/3 (33.33%)  1
Erythema   1/3 (33.33%)  1
Rash   1/3 (33.33%)  2
Vascular disorders   
Flushing   1/3 (33.33%)  1
Hypotension   1/3 (33.33%)  1
Indicates events were collected by systematic assessment
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) )
First Submitted: February 10, 2012
First Posted: February 20, 2012
Results First Submitted: May 3, 2016
Results First Posted: June 10, 2016
Last Update Posted: June 10, 2016