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VELCADE,Rituximab,Cyclophosphamide and Decadron (VRCD)

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ClinicalTrials.gov Identifier: NCT00413959
Recruitment Status : Terminated
First Posted : December 20, 2006
Results First Posted : September 27, 2013
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Interventions Drug: VELCADE®
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Decadron
Enrollment 12
Recruitment Details Rituximab (R) are alone or R based chemo programs are front line approach LG-NHL pts requiring therapy. Identifying programs that are effective in the elderly pts is challenging. These pts were recruited in our private practice.
Pre-assignment Details Eligible pts had LG-NHL requiring treatment. Mantel cell NHL pts who were'nt transplant eligible and MALToma pts who failed RT and antibiotics were allowed.
Arm/Group Title Velcade, Rituximab,Cyclophosphamide & Decadron
Hide Arm/Group Description Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
Period Title: Overall Study
Started 12
Completed 11
Not Completed 1
Reason Not Completed
Pt had only one cycle.             1
Arm/Group Title Velcade, Rituximab,Cyclophosphamide & Decadron
Hide Arm/Group Description Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
   8.3%
>=65 years
11
  91.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
4
  33.3%
Male
8
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title Overall Response Rate Using This Regimen in Patients With Low-grade B-Cell Non-Hodgkin's Lymphoma.
Hide Description Percentage of complete responders plus percentage of partial responders equals overall response rate.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 pt withdrew before completing two cycles and was not evaluable for OS.
Arm/Group Title Velcade, Rituximab,Cyclophosphamide & Decadron
Hide Arm/Group Description:
Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of patients
90
2.Secondary Outcome
Title Overall Survival
Hide Description The study was closed prematurely due to slow accrual. When the study closed only two patients had died, making the OS 83%.
Time Frame 4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Velcade, Rituximab,Cyclophosphamide & Decadron
Hide Arm/Group Description:
Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: percentage of participants
83
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Velcade, Rituximab,Cyclophosphamide & Decadron
Hide Arm/Group Description Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
All-Cause Mortality
Velcade, Rituximab,Cyclophosphamide & Decadron
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Velcade, Rituximab,Cyclophosphamide & Decadron
Affected / at Risk (%)
Total   2/12 (16.67%) 
Cardiac disorders   
Congestive Heart Failure  1/12 (8.33%) 
Nervous system disorders   
Cerebral Vascular Accident  1/12 (8.33%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Velcade, Rituximab,Cyclophosphamide & Decadron
Affected / at Risk (%)
Total   12/12 (100.00%) 
Blood and lymphatic system disorders   
Leukopenia Grade 1 & 2  2/12 (16.67%) 
Tronopin Increased Grade 1 & 2  1/12 (8.33%) 
Leukopenia Grade 3 & 4  3/12 (25.00%) 
Neutropenia Grade 3 & 4  3/12 (25.00%) 
Cardiac disorders   
Hypertension Grade 1 & 2  1/12 (8.33%) 
Gastrointestinal disorders   
Abdominal Pain Grade 1 & 2  1/12 (8.33%) 
Appetite Decreased Grade 1 & 2  1/12 (8.33%) 
Constipation Grade 1 & 2  1/12 (8.33%) 
Hyponatremia Grade 1 & 2  1/12 (8.33%) 
Hyperglycemia Grade 1 & 2  2/12 (16.67%) 
Nausea Grade 1 & 2  3/12 (25.00%) 
Mucositis Grade 1 & 2  1/12 (8.33%) 
Stomatitis Grade 1 & 2  1/12 (8.33%) 
Weight Decreased Grade 1 & 2  2/12 (16.67%) 
Vomiting Grade 1 & 2  1/12 (8.33%) 
Hyperglycemia Grade 3 & 4  1/12 (8.33%) 
General disorders   
Anxiety Grade 1 & 2  2/12 (16.67%) 
Alopecia Grade 1 & 2  1/12 (8.33%) 
Chills Grade 1 & 2  2/12 (16.67%) 
Edema Grade 1 & 2  2/12 (16.67%) 
Fever Grade 1 & 2  1/12 (8.33%) 
Fatigue Grade 1 & 2  4/12 (33.33%) 
Insomnia Grade 1 & 2  1/12 (8.33%) 
Sweats Grade 1 & 2  2/12 (16.67%) 
Triglyceride Increased Grade 1 & 2  1/12 (8.33%) 
Tongue Swelling Grade 1 & 2  1/12 (8.33%) 
Tooth Abcess Grade 1 & 2  1/12 (8.33%) 
Headache Grade 1 & 2  1/12 (8.33%) 
Pain Grade 1 & 2  2/12 (16.67%) 
Musculoskeletal and connective tissue disorders   
Difficulty Walking Grade 1 & 2  2/12 (16.67%) 
Chest Pain Grade 3 & 4  1/12 (8.33%) 
Renal and urinary disorders   
Bilirubin Increased Grade 1 & 2  1/12 (8.33%) 
Creatinine Increased Grade 1 & 2  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough Grade 1 & 2  1/12 (8.33%) 
Pulmonary Edema Grade 1 & 2  1/12 (8.33%) 
Sinus Congestion Grade 1 & 2  1/12 (8.33%) 
Orthopnea Grade 3 & 4  1/12 (8.33%) 
Pulmonary Edema Grade 3 & 4  1/12 (8.33%) 
Pulmonary Emboli Grade 3 & 4  1/12 (8.33%) 
Shortness of Breath Grade 3 & 4  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Rash Grade 1 & 2  1/12 (8.33%) 
Nail Changes Grade 1 & 2  1/12 (8.33%) 
Dry Skin Grade 1 & 2  1/12 (8.33%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Sigrun Hallmeyer, MD Director of Research
Organization: Oncology Specialists SC
Phone: 847-268-8200
Responsible Party: Dr. Sigrun Hallmeyer, Oncology Specialists, S.C.
ClinicalTrials.gov Identifier: NCT00413959     History of Changes
Other Study ID Numbers: 0606
First Submitted: December 19, 2006
First Posted: December 20, 2006
Results First Submitted: May 7, 2013
Results First Posted: September 27, 2013
Last Update Posted: September 19, 2018