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Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01083316
First Posted: March 9, 2010
Last Update Posted: May 12, 2017
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.
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Vaishali Sanchorawala, Boston Medical Center
Results First Submitted: December 13, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Amyloidosis
Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: Melphalan

  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 and Dexamethasone

Induction:

Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days

Conditioning:

Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1

Bortezomib (Velcade) and Dexamethasone: Induction:

Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days

Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days

Conditioning:

Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4

Melphalan 70-100 mg/m2/day IV on days -2 and -1


Participant Flow:   Overall Study
    Bortezomib and Dexamethasone
STARTED   35 
COMPLETED   32 
NOT COMPLETED   3 
Adverse Event                2 
Withdrawal by Subject                1 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Bortezomib and Dexamethasone

Induction:

Bortezomib (Velcade) 1.3 mg/m2/dose intravenous (IV) Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days

Conditioning:

Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1

Bortezomib (Velcade) and Dexamethasone: Induction:

Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days

Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days

Conditioning:

Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4

Melphalan 70-100 mg/m2/day IV on days -2 and -1


Baseline Measures
   Bortezomib and Dexamethasone 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      30  85.7% 
>=65 years      5  14.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      22  62.9% 
Male      13  37.1% 


  Outcome Measures
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1.  Primary:   Number of Participants With Disease Response   [ Time Frame: One year ]

2.  Primary:   Number of Participants Surviving at 100 Days Post Transplant   [ Time Frame: 100 days ]

3.  Primary:   Number of Participants Proceeding to Transplant Following Induction   [ Time Frame: 2 months ]

4.  Secondary:   Number of Participants Surviving at 5 Years   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   12/2018  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Vaishali Sanchorawala
Organization: Boston Medical Center
phone: 6176386521
e-mail: vaishali.sanchorawala@bmc.org



Responsible Party: Vaishali Sanchorawala, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01083316     History of Changes
Other Study ID Numbers: H-28441
X05292 ( Other Identifier: Millennium )
First Submitted: November 2, 2009
First Posted: March 9, 2010
Results First Submitted: December 13, 2016
Results First Posted: February 6, 2017
Last Update Posted: May 12, 2017