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Trial record 73 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

DTPACE Followed by Tandem Transplant With Melphalan (MEL) 200 Versus MEL/Dexamethasone/Thalidomide (DT) Platinol/Adriamycin/Etoposide (PACE) Hybrid and DTPACE Consolidation

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ClinicalTrials.gov Identifier: NCT00083915
Recruitment Status : Completed
First Posted : June 4, 2004
Results First Posted : August 3, 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: Cisplatin
Drug: Cyclophosphamide
Drug: Adriamycin
Drug: Etoposide
Drug: Melphalan
Drug: Thalidomide
Drug: Dexamethasone
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Dose Melphalan Mel-DT PACE
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 52 45
Completed 2 8
Not Completed 50 37
Reason Not Completed
Death             6             3
Physician Decision             11             6
Withdrawal by Subject             8             3
disease progression             18             23
Failure to collect             3             0
No response             3             1
Insurance issues             1             1
Arm/Group Title High Dose Melphalan Mel-DT PACE Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 52 45 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 45 participants 97 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
  51.9%
24
  53.3%
51
  52.6%
>=65 years
25
  48.1%
21
  46.7%
46
  47.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 45 participants 97 participants
64.83  (8.77) 65.5  (8.36) 65.14  (8.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 45 participants 97 participants
Female
22
  42.3%
19
  42.2%
41
  42.3%
Male
30
  57.7%
26
  57.8%
56
  57.7%
1.Primary Outcome
Title Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone.
Hide Description Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)
Time Frame 3 years depending on start date
Hide Outcome Measure Data
Hide Analysis Population Description
only 2 participants in high dose (HD) melphalan group completed the study and only 8 from the Mel-DT Pace group completed the study. No analysis done.
Arm/Group Title High Dose Melphalan Mel-DT PACE
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 High Dose Melphalan Mel-DT PACE
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
High Dose Melphalan Mel-DT PACE
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Melphalan Mel-DT PACE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/52 (11.54%)      3/45 (6.67%)    
General disorders     
death   6/52 (11.54%)  6 3/45 (6.67%)  3
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%
High Dose Melphalan Mel-DT PACE
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/52 (51.92%)      24/45 (53.33%)    
Blood and lymphatic system disorders     
DVT *  4/52 (7.69%)  7 4/45 (8.89%)  5
Diverticulitis   2/52 (3.85%)  2 1/45 (2.22%)  1
supraventricular tachycardia   0/52 (0.00%)  0 1/45 (2.22%)  1
hemorrhagic colitis   1/52 (1.92%)  1 0/45 (0.00%)  0
Cardiac disorders     
chest pain   1/52 (1.92%)  1 0/45 (0.00%)  0
Gastrointestinal disorders     
nausea, vomiting, diarrhea & fever   5/52 (9.62%)  7 4/45 (8.89%)  5
difficile colitis *  1/52 (1.92%)  1 0/45 (0.00%)  0
General disorders     
neutropenic fever   5/52 (9.62%)  5 4/45 (8.89%)  5
pneumonia   3/52 (5.77%)  3 2/45 (4.44%)  2
headcache, rhinitis *  0/52 (0.00%)  0 1/45 (2.22%)  1
hematoma *  1/52 (1.92%)  1 1/45 (2.22%)  1
fracture *  1/52 (1.92%)  1 1/45 (2.22%)  1
edema   0/52 (0.00%)  0 1/45 (2.22%)  1
dehydration   0/52 (0.00%)  0 1/45 (2.22%)  1
Infections and infestations     
CVL infection *  1/52 (1.92%)  1 1/45 (2.22%)  1
Renal and urinary disorders     
bladder cancer   1/52 (1.92%)  1 0/45 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
plasma cells in lungs *  0/52 (0.00%)  0 1/45 (2.22%)  1
Skin and subcutaneous tissue disorders     
drug rash   1/52 (1.92%)  1 0/45 (0.00%)  0
Vascular disorders     
stroke   0/52 (0.00%)  0 1/45 (2.22%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Nathan M. Petty
Organization: University of Arkansas for Medical Sciences, Myeloma Institute
Phone: 501-526-6990 ext 2461
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00083915     History of Changes
Other Study ID Numbers: UARK 2001-12
First Submitted: June 3, 2004
First Posted: June 4, 2004
Results First Submitted: July 7, 2011
Results First Posted: August 3, 2011
Last Update Posted: November 20, 2017