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Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis

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ClinicalTrials.gov Identifier: NCT00790647
Recruitment Status : Completed
First Posted : November 13, 2008
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Vaishali Sanchorawala, Boston Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Biological: filgrastim
Drug: bortezomib
Drug: melphalan
Procedure: Stem Cell Infusion
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SCT With Bortezomib and Melphalan
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Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion

filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC

bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4

melphalan: 100 mg/m2/dose D –2, D –1

Stem Cell Infusion: infusion of previously collected autologous stem cells

Period Title: Overall Study
Started 10
Completed 9
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title SCT With Bortezomib and Melphalan
Hide Arm/Group Description

Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion

filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC

bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4

melphalan: 100 mg/m2/dose D –2, D –1

Stem Cell Infusion: infusion of previously collected autologous stem cells

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
5
  50.0%
Male
5
  50.0%
1.Primary Outcome
Title Number of Participants With Hematologic Response
Hide Description

complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy <5% plasma cells with no clonal predominance of kappa or lambda isotype.

Partial response: any one of the following

  1. For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells.
  2. For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more.
  3. For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume).
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Transplant With Bortezomib and Melphalan
Hide Arm/Group Description:

Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion

filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection

bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4

melphalan: 100 mg/m2/dose D –2, D –1

Stem Cell Infusion: infusion of previously collected autologous stem cells

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
6
2.Secondary Outcome
Title Number of Participants Surviving at 100 Days From Transplant
Hide Description [Not Specified]
Time Frame 100 Days from transplant date
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Transplant With Bortezomib and Melphalan
Hide Arm/Group Description:

Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion

filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection

bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4

melphalan: 100 mg/m2/dose D –2, D –1

Stem Cell Infusion: infusion of previously collected autologous stem cells

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
9
3.Secondary Outcome
Title Number of Participants Surviving at 1 Year
Hide Description [Not Specified]
Time Frame one year from transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Transplantation With Bortezomib and Melphalan
Hide Arm/Group Description:

Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion

filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection

bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4

melphalan: 100 mg/m2/dose D –2, D –1

Stem Cell Infusion: infusion of previously collected autologous stem cells

Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
9
4.Secondary Outcome
Title Number of Participants Surviving at 2 Years
Hide Description [Not Specified]
Time Frame 2 years from transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stem Cell Transplant With Bortezomib and Melphalan
Hide Arm/Group Description:

Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion

filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection

bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4

melphalan: 100 mg/m2/dose D –2, D –1

Stem Cell Infusion: infusion of previously collected autologous stem cells

Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
9
 100.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SCT With Bortezomib and Melphalan
Hide Arm/Group Description

Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion

filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC

bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4

melphalan: 100 mg/m2/dose D –2, D –1

Stem Cell Infusion: infusion of previously collected autologous stem cells

All-Cause Mortality
SCT With Bortezomib and Melphalan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SCT With Bortezomib and Melphalan
Affected / at Risk (%) # Events
Total   9/9 (100.00%)    
Blood and lymphatic system disorders   
pancytopenia * 1  9/9 (100.00%)  9
coagulation * 1 [1]  1/9 (11.11%)  1
febrile neutropenia * 2  2/9 (22.22%)  2
Cardiac disorders   
elevated troponin I * 2  1/9 (11.11%)  1
Gastrointestinal disorders   
nausea * 2  1/9 (11.11%)  1
vomit * 2  1/9 (11.11%)  1
diarrhea * 2  3/9 (33.33%)  3
heartburn * 2  1/9 (11.11%)  1
GI bleed * 2  1/9 (11.11%)  1
General disorders   
fatigue * 1  2/9 (22.22%)  2
edema * 2 [2]  2/9 (22.22%)  2
deconditioning * 2  1/9 (11.11%)  1
Investigations   
increased alkylase phosphate * 2  1/9 (11.11%)  1
creatinine increased * 2  1/9 (11.11%)  1
decreased phosphate * 2  1/9 (11.11%)  1
hypocalcemia * 2  3/9 (33.33%)  3
hypoalbuminemia * 2  2/9 (22.22%)  2
Respiratory, thoracic and mediastinal disorders   
Infection * 2 [3]  1/9 (11.11%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
2
Term from vocabulary, CTCAE (3.0)
[1]
fibrinogen
[2]
limbs
[3]
pneumonia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SCT With Bortezomib and Melphalan
Affected / at Risk (%) # Events
Total   9/9 (100.00%)    
Gastrointestinal disorders   
nausea * 1  3/9 (33.33%)  5
diarrhea * 1  4/9 (44.44%)  6
General disorders   
fatigue * 1  7/9 (77.78%)  7
deconditioning * 1  6/9 (66.67%)  6
hiccups * 1  4/9 (44.44%)  5
Investigations   
creatinine increased * 1  1/9 (11.11%)  1
increased alkylase phosphate * 1  8/9 (88.89%)  8
hypocalcemia * 1  3/9 (33.33%)  4
hypoalbuminemia * 1  1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
dyspnea * 1  2/9 (22.22%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Vaishali Sanchorawala
Organization: Boston Medical Center
Phone: 617-638-8265
EMail: vaishali.sanchorawala@bmc.org
Layout table for additonal information
Responsible Party: Vaishali Sanchorawala, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00790647     History of Changes
Other Study ID Numbers: CDR0000618857
BUMC-H-27277 ( Other Identifier: Boston University Medical Center IRB )
First Submitted: November 12, 2008
First Posted: November 13, 2008
Results First Submitted: September 9, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017