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Trial record 5 of 82 for:    abp 798

Carfilzomib With or Without Rituximab in the Treatment of Waldenstrom Macroglobulinemia or Marginal Zone Lymphoma

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.
 
ClinicalTrials.gov Identifier: NCT03269552
Recruitment Status : Terminated (Terminated due to low accrual.)
First Posted : August 31, 2017
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Marginal Zone Lymphoma
Recurrent Marginal Zone Lymphoma
Recurrent Waldenstrom Macroglobulinemia
Refractory Marginal Zone Lymphoma
Refractory Waldenstrom Macroglobulinemia
Waldenstrom Macroglobulinemia
Interventions Drug: Carfilzomib
Other: Laboratory Biomarker Analysis
Biological: Rituximab
Enrollment 4
Recruitment Details  
Pre-assignment Details 4 participants signed informed consent, met eligibility and continued on to study treatment.
Arm/Group Title Treatment (Carfilzomib, Rituximab)
Hide Arm/Group Description

Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.

Carfilzomib: Given IV

Laboratory Biomarker Analysis: Correlative studies

Rituximab: Given IV

Period Title: Overall Study
Started 4
Completed 2
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Treatment (Carfilzomib, Rituximab)
Hide Arm/Group Description

Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib, receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.

Carfilzomib: Given IV

Laboratory Biomarker Analysis: Correlative studies

Rituximab: Given IV

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  50.0%
>=65 years
2
  50.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
64.25
(59 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
4
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 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
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Overall Response Rate
Hide Description Descriptive statistics will be used for baseline characteristics, and responses to treatment.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were evaluated after cycle 2 day 15 and prior to cycle 3 day 1.
Arm/Group Title Treatment (Carfilzomib, Rituximab)
Hide Arm/Group Description:

Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.

Carfilzomib: Given IV

Laboratory Biomarker Analysis: Correlative studies

Rituximab: Given IV

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
0
   0.0%
Very good partial response
0
   0.0%
Partial response
2
  50.0%
Minor response
1
  25.0%
Stable disease
1
  25.0%
Progressive disease
0
   0.0%
2.Secondary Outcome
Title Overall Survival
Hide Description Estimated using Kaplan-Meier analysis.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Carfilzomib, Rituximab)
Hide Arm/Group Description:

Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib, receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.

Carfilzomib: Given IV

Laboratory Biomarker Analysis: Correlative studies

Rituximab: Given IV

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
3.Secondary Outcome
Title Time to Best Response
Hide Description Estimated using Kaplan-Meier analysis.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Carfilzomib, Rituximab)
Hide Arm/Group Description:

Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.

Carfilzomib: Given IV

Laboratory Biomarker Analysis: Correlative studies

Rituximab: Given IV

Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: Months
2
(0.5 to 3)
4.Secondary Outcome
Title Time to Progression
Hide Description Estimated using Kaplan-Meier analysis.
Time Frame Up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Carfilzomib, Rituximab)
Hide Arm/Group Description:

Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.

Carfilzomib: Given IV

Laboratory Biomarker Analysis: Correlative studies

Rituximab: Given IV

Overall Number of Participants Analyzed 4
Median (Standard Error)
Unit of Measure: Months
8  (0.05)
Time Frame Adverse events are reported from the time the subject receives their first dose of study drug through 30 days post-last dose of study drug or initiation of a new anti-cancer therapy, whichever occurs first.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Carfilzomib, Rituximab)
Hide Arm/Group Description

Patients receive carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who fail to achieve at least 25% M-protein reduction for Waldenstrom's macroglobulinemia or partial response for marginal zone lymphoma after 2 courses of carfilzomib will continue to receive carfolzomib for 4 more courses. In addition, they will also receive rituximab IV weekly on days 1, 8, 15, and 22 of course 3 and then monthly on day 1 of courses 4-6 in the absence of disease progression or unacceptable toxicity.

Carfilzomib: Given IV

Laboratory Biomarker Analysis: Correlative studies

Rituximab: Given IV

All-Cause Mortality
Treatment (Carfilzomib, Rituximab)
Affected / at Risk (%)
Total   0/4 (0.00%)    
Hide Serious Adverse Events
Treatment (Carfilzomib, Rituximab)
Affected / at Risk (%) # Events
Total   1/4 (25.00%)    
Blood and lymphatic system disorders   
Microangiopathic Hemolytic Anemia  1  1/4 (25.00%)  1
1
Term from vocabulary, CTCAE (Unspecified)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Carfilzomib, Rituximab)
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/4 (25.00%)  1
Endocrine disorders   
Hypothyroidism  1  1/4 (25.00%)  1
Gastrointestinal disorders   
Constipation  1  1/4 (25.00%)  1
Flatulance  1  2/4 (50.00%)  3
Nausea  1  2/4 (50.00%)  2
Vomiting  1  1/4 (25.00%)  2
General disorders   
Chills  1  2/4 (50.00%)  3
Cough  1  1/4 (25.00%)  1
Fatigue  1  2/4 (50.00%)  2
Flu Like Symptoms  1  1/4 (25.00%)  1
Fluid Retention  1  1/4 (25.00%)  1
Warm Sensation  1  1/4 (25.00%)  1
Non-Cardiac Chest Pain  1  2/4 (50.00%)  2
Investigations   
Neutrophil Count Decreased  1  1/4 (25.00%)  1
Platelet Count Decreased  1  2/4 (50.00%)  3
White Blood Cell Count Decreased  1  1/4 (25.00%)  1
Musculoskeletal and connective tissue disorders   
Bursitis  1  1/4 (25.00%)  1
Nervous system disorders   
Headache  1  1/4 (25.00%)  2
Increased Cold Sensitivity  1 [1]  1/4 (25.00%)  1
Psychiatric disorders   
Insomnia  1  1/4 (25.00%)  1
Renal and urinary disorders   
Decreased Urination  1  1/4 (25.00%)  1
Renal Failure  1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/4 (25.00%)  1
Skin and subcutaneous tissue disorders   
Dry Skin  1  1/4 (25.00%)  1
Vascular disorders   
Hypertension  1  1/4 (25.00%)  1
1
Term from vocabulary, CTCAE (Unspecified)
Indicates events were collected by systematic assessment
[1]
In fingertips
Early termination due to low accrual leading to small number of subjects analyzed.
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: Dr. Stephen Smith
Organization: University of Washington
Phone: 206-606-6546
EMail: ssmith50@seattlecca.org
Layout table for additonal information
Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03269552    
Other Study ID Numbers: 9702
NCI-2017-01548 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9702 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
RG1716046 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Submitted: August 29, 2017
First Posted: August 31, 2017
Results First Submitted: December 2, 2019
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020