Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00083551
First received: May 25, 2004
Last updated: October 21, 2015
Last verified: October 2015
Results First Received: August 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Thalidomide
Drug: Ara-C
Drug: BCNU
Drug: Cisplatin
Drug: Cytoxan
Drug: Dexamethasone
Drug: Doxorubicin
Drug: Etoposide
Drug: Filgrastim
Drug: Recombinant GM-CSF
Drug: Interferon-alpha-2b
Drug: Melphalan
Drug: Vincristine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Thalidomide Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
No Thalidomide Patient received no thalidomide during induction, consolidation, and maintenance therapy.

Participant Flow:   Overall Study
    Thalidomide   No Thalidomide
STARTED   323   345 
COMPLETED   323   345 
NOT COMPLETED   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Thalidomide Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
No Thalidomide Patient received no thalidomide during induction, consolidation, and maintenance therapy.
Total Total of all reporting groups

Baseline Measures
   Thalidomide   No Thalidomide   Total 
Overall Participants Analyzed 
[Units: Participants]
 323   345   668 
Age, Customized 
[Units: Participants]
     
>/= 60 to < 65 years   130   129   259 
>/= 65 years   64   72   136 
< 60 years   129   144   273 
Gender 
[Units: Participants]
     
Female   137   135   272 
Male   186   210   396 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: 6 Years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bart Barlogie
Organization: UAMS Myeloma Institute
phone: 501-526-6990 ext 2420
e-mail: barlogiebart@uams.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00083551     History of Changes
Other Study ID Numbers: 5226
Study First Received: May 25, 2004
Results First Received: August 24, 2015
Last Updated: October 21, 2015
Health Authority: United States: Food and Drug Administration