Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 99 of 108 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

UARK 2006-15: A Study of Tandem Transplants With or Without Bortezomib and Thalidomide

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: NCT00574080
Recruitment Status : Terminated (low accrual)
First Posted : December 14, 2007
Results First Posted : June 30, 2011
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Interim/Maintenance Dexamethasone
Drug: Induction/Consolidation Dexamethasone
Drug: Induction/Consolidation Cisplatin
Drug: Induction/Consolidation Adriamycin
Drug: InductionConsolidation Cyclophosphamide
Drug: Induction/Consolidation Etoposide
Drug: Induction Pegfilgrastim
Drug: Transplant 1 Dexamethasone
Drug: Transplant 1 Cisplatin
Drug: Transplant 1 Adriamycin
Drug: Transplant 1 Cyclophosphamide
Drug: Transplant 1 Etoposide
Drug: Transplant 1 Melphalan
Drug: Transplant 1 and 2 Pegfilgrastim
Procedure: Autologous Peripheral Blood Stem Cell Transplant (ASCT)
Drug: Transplant 2 Carmustine
Drug: Transplant 2 Etoposide
Drug: Transplant 2 Cytarabine
Drug: Transplant 2 Melphalan
Drug: Transplant 2 Dexamethasone
Drug: Transplant 1 and 2 Bortezomib
Drug: Transplant 1 and 2 Thalidomide
Enrollment 20
Recruitment Details Participants are myeloma patients who have already received one or more treatment regimens and are seen at our facility
Pre-assignment Details  
Arm/Group Title VTD + DPACE/Melphalan DPACE/Melphalan
Hide Arm/Group Description Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
Period Title: Overall Study
Started 10 10
Completed 0 0
Not Completed 10 10
Reason Not Completed
Death             10             10
Arm/Group Title VTD + DPACE/Melphalan DPACE/Melphalan Total
Hide Arm/Group Description Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
6
  60.0%
16
  80.0%
>=65 years
0
   0.0%
4
  40.0%
4
  20.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
56.2  (5.01) 59  (8.67) 57.6  (7.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
6
  60.0%
5
  50.0%
11
  55.0%
Male
4
  40.0%
5
  50.0%
9
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Event Free Survival
Hide Description Time from study registration until disease progression or death.
Time Frame Up to 3 years 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
no analysis, participants either died or were withdrawn by PI. study terminated with <10% of target accrual enrolled.
Arm/Group Title Arm A Arm B
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VTD + DPACE/Melphalan DPACE/Melphalan
Hide Arm/Group Description Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
All-Cause Mortality
VTD + DPACE/Melphalan DPACE/Melphalan
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
VTD + DPACE/Melphalan DPACE/Melphalan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/10 (40.00%)      3/10 (30.00%)    
Blood and lymphatic system disorders     
embolus   0/10 (0.00%)  0 1/10 (10.00%)  1
Cardiac disorders     
death  [1]  0/10 (0.00%)  0 1/10 (10.00%)  1
General disorders     
death  1 [2]  1/10 (10.00%)  1 0/10 (0.00%)  0
death  [3]  2/10 (20.00%)  2 0/10 (0.00%)  0
death  [4]  0/10 (0.00%)  0 1/10 (10.00%)  1
death  [5]  1/10 (10.00%)  1 0/10 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
death  [6]  0/10 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, progressive disease
[1]
cardiac failure
[2]
progressive disease
[3]
no cause listed
[4]
infection
[5]
sepsis
[6]
secondary malignancy
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VTD + DPACE/Melphalan DPACE/Melphalan
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Early termination led to small numbers of subjects to be analyzed. Less than 10% of the target accrual were enrolled before termination of study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nathan M. Petty
Organization: University of Arkansas for Medical Sciences, Myeloma Institute
Phone: 501-526-6990 ext 2461
EMail: PettyNathanM@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00574080     History of Changes
Other Study ID Numbers: 2006-15
First Submitted: December 12, 2007
First Posted: December 14, 2007
Results First Submitted: May 4, 2011
Results First Posted: June 30, 2011
Last Update Posted: November 20, 2017