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A Study Evaluating Efficacy, Toxicity, Harvest Yield and Quality of Life

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ClinicalTrials.gov Identifier: NCT00222105
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : May 1, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
University of Kansas Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Doxil
Drug: Thalidomide
Drug: Dexamethasone
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1
Hide Arm/Group Description

Doxil, Thalidomide, Dexamethasone

Doxil: Doxil 40 mg/m2 IV day 1

Thalidomide: 50-100 mg day 1-28

Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18

Period Title: Overall Study
Started 25
Completed 11
Not Completed 14
Reason Not Completed
Removed due to wrong diagnosis             1
Withdrawal by Subject             1
Adverse Event             8
Treatment delays             2
Death             2
Arm/Group Title Arm 1
Hide Arm/Group Description

Doxil, Thalidomide, Dexamethasone

Doxil: Doxil 40 mg/m2 IV day 1

Thalidomide: 50-100 mg day 1-28

Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
61
(49 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
8
  32.0%
Male
17
  68.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
 100.0%
1.Primary Outcome
Title Overall Response Rate
Hide Description Response rate after completion of first cycle. Measured as the proportion of subjects who have a partial response (PR) or complete response (CR), represented as the overall response rate (ORR). SWOG/IBMTR (Southwest Oncology Group/International Blood and Marrow Transplant Research) criteria utilized to determine multiple myeloma response rates.
Time Frame At End of Cycle 1, 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects did not complete first cycle.
Arm/Group Title Arm 1
Hide Arm/Group Description:

Doxil, Thalidomide, Dexamethasone

Doxil: Doxil 40 mg/m2 IV day 1

Thalidomide: 50-100 mg day 1-28

Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18

Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
95
2.Secondary Outcome
Title Toxicity
Hide Description Count of Participants with adverse events.
Time Frame End of study, up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1
Hide Arm/Group Description:

Doxil, Thalidomide, Dexamethasone

Doxil: Doxil 40 mg/m2 IV day 1

Thalidomide: 50-100 mg day 1-28

Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18

Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1
Hide Arm/Group Description

Doxil, Thalidomide, Dexamethasone

Doxil: Doxil 40 mg/m2 IV day 1

Thalidomide: 50-100 mg day 1-28

Dexamethasone: Dexamethasone 40 mg day 1-4 and 15-18

All-Cause Mortality
Arm 1
Affected / at Risk (%)
Total   2/25 (8.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1
Affected / at Risk (%) # Events
Total   8/25 (32.00%)    
Cardiac disorders   
Arrhythmia   1/25 (4.00%)  1
Infections and infestations   
Infection   5/25 (20.00%)  5
Metabolism and nutrition disorders   
Dehydration   1/25 (4.00%)  1
Renal and urinary disorders   
Acute Renal Failure   1/25 (4.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1
Affected / at Risk (%) # Events
Total   0/25 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Cancer Center Clinical Trials Office
Organization: University of Kansas Medical Center
Phone: (913) 945-5059
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00222105     History of Changes
Other Study ID Numbers: Doxil
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: March 21, 2017
Results First Posted: May 1, 2017
Last Update Posted: July 2, 2017