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Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study

This study has been terminated.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Sagar Lonial, Emory University
ClinicalTrials.gov Identifier:
NCT00793650
First received: November 17, 2008
Last updated: August 17, 2012
Last verified: August 2012
History of Changes
Results First Received: March 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cancer
Multiple Myeloma
Interventions: Drug: Bortezomib
Drug: Melphalan
Procedure: Autologous PBSC Transplant

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bortezomib Before HD Melphalan

All patients received melphalan (100 mg/m^2/day × 2; days

−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2
Bortezomib After HD melphalanAll

patients received melphalan (100 mg/m^2/day × 2; days

−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2

Participant Flow:   Overall Study
    Bortezomib Before HD Melphalan     Bortezomib After HD melphalanAll  
STARTED     19     20  
COMPLETED     19     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Bortezomib Before HD Melphalan

All patients received melphalan (100 mg/m^2/day × 2; days

−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2
Bortezomib After HD melphalanAll

patients received melphalan (100 mg/m^2/day × 2; days

−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2
Total Total of all reporting groups

Baseline Measures
    Bortezomib Before HD Melphalan     Bortezomib After HD melphalanAll     Total  
Number of Participants  
[units: participants]
 		  19     20     39  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     14     14     28  
>=65 years     5     6     11  
Age  
[units: years]
Mean ± Standard Deviation 		  58.32  ± 7.92     58.75  ± 8.05     58.54  ± 7.88  
Gender  
[units: participants]
 		     
Female     9     7     16  
Male     10     13     23  
Region of Enrollment  
[units: participants]
 		     
United States     19     20     39  



  Outcome Measures
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1.  Primary:   Safety and Engraftment   [ Time Frame: Day 30 after transplant ]
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2.  Secondary:   Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.   [ Time Frame: 100 days after transplant ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
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Results Point of Contact:  
Name/Title: Dr. Sagar Lonial
Organization: Emory University
phone: 404-727-5572
e-mail: sloni01@emory.edu


No publications provided


Responsible Party: Sagar Lonial, Emory University
ClinicalTrials.gov Identifier: NCT00793650     History of Changes
Other Study ID Numbers: 080-2005
Study First Received: November 17, 2008
Results First Received: March 14, 2012
Last Updated: August 17, 2012
Health Authority: United States: Institutional Review Board