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Trial record 2 of 23 for:    "Al Amyloidosis" | "Cyclophosphamide"

Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis

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ClinicalTrials.gov Identifier: NCT01072773
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : December 5, 2012
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Systemic Amyloidosis
Interventions Drug: bortezomib
Drug: cyclophosphamide
Drug: dexamethasone
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bortez/Cyc/Dex
Hide Arm/Group Description Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Bortez/Cyc/Dex
Hide Arm/Group Description Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
2
 100.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants
69
(67 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
2
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
Prior Treatment   [1] 
Mean (Full Range)
Unit of measure:  Prior Treatments
Number Analyzed 2 participants
6.5
(1 to 11)
[1]
Measure Description: Number of previous regimens used for the treatment of amyloidosis. There is no limit to the number of prior therapies provided there is adequate residual organ function.
1.Primary Outcome
Title Number of Participants With a Confirmed Hematologic Response
Hide Description

Response that was confirmed on 2 consecutive evaluations during treatment.

Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.

Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <=100 mg per 24 hours.

Partial Response(PR): >=50% reduction in serum M-component and/or Urine M-Component >=90% reduction or <200 mg per 24 hours; or >=50% decrease in difference between involved and uninvolved FLC levels.

Time Frame Duration of treatment (up to 12 cycles/months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortez/Cyc/Dex
Hide Arm/Group Description:
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0
Very Good Partial Response (VGPR) 0
Partial Response (PR) 0
2.Secondary Outcome
Title Number of Participants With Treatment Related Adverse Events.
Hide Description

Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.

Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE

Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.

Time Frame Duration on treatment (up to 12 cycles/months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortez/Cyc/Dex
Hide Arm/Group Description:
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
Grade 1-2 2
Grade 3-4 0
Grade 5 0
3.Secondary Outcome
Title Number of Participants With an Organ Response.
Hide Description The number of patients that acheived a response in an affected organ.
Time Frame Duration on treatment (up to 12 cycles/months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortez/Cyc/Dex
Hide Arm/Group Description:
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: participants
0
4.Secondary Outcome
Title Overall Survival
Hide Description Survival time is defined as the time from registration to death due to any cause.
Time Frame Duration of Study (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortez/Cyc/Dex
Hide Arm/Group Description:
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
Overall Number of Participants Analyzed 2
Median (95% Confidence Interval)
Unit of Measure: Months
1.45
(1.35 to 1.54)
5.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to disease progression is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death
Time Frame Duration of Study (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bortez/Cyc/Dex
Hide Arm/Group Description:
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
Overall Number of Participants Analyzed 2
Median (95% Confidence Interval)
Unit of Measure: Months
1.45
(1.35 to 1.54)
6.Secondary Outcome
Title Duration of Response
Hide Description Duration of response will be calculated from the date of first evidence of response until the date of progression in the subset of patients with confirmed hematologic responses.
Time Frame Duration of Study (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Neither participant achieved a response. Therefore, no duration of response calculation was performed.
Arm/Group Title Bortez/Cyc/Dex
Hide Arm/Group Description:
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bortez/Cyc/Dex
Hide Arm/Group Description Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
All-Cause Mortality
Bortez/Cyc/Dex
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bortez/Cyc/Dex
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Cardiac disorders   
Atrial fibrillation  1  1/2 (50.00%)  1
Infections and infestations   
Lung infection  1  1/2 (50.00%)  1
Investigations   
Lymphocyte count decreased  1  1/2 (50.00%)  1
Neutrophil count decreased  1  1/2 (50.00%)  1
White blood cell decreased  1  1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary hemorrhage  1  1/2 (50.00%)  1
Dyspnea  1  1/2 (50.00%)  1
Respiratory failure  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bortez/Cyc/Dex
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Gastrointestinal disorders   
Constipation  1  1/2 (50.00%)  1
Diarrhea  1  1/2 (50.00%)  1
General disorders   
Edema limbs  1  2/2 (100.00%)  2
Fatigue  1  2/2 (100.00%)  2
Infections and infestations   
Urinary tract infection  1  1/2 (50.00%)  1
Investigations   
Creatinine increased  1  2/2 (100.00%)  3
Platelet count decreased  1  1/2 (50.00%)  1
Metabolism and nutrition disorders   
Hypokalemia  1  1/2 (50.00%)  1
Hyponatremia  1  1/2 (50.00%)  1
Nervous system disorders   
Peripheral motor neuropathy  1  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10
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: Dr. Shaji Kumar
Organization: Mayo Clinic
EMail: kumar.shaji@mayo.edu
Layout table for additonal information
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01072773     History of Changes
Other Study ID Numbers: MC0985
NCI-2009-01564 ( Registry Identifier: NCI's CTRP )
09-005736 ( Other Identifier: Mayo Clinic IRB )
MC0985 ( Other Identifier: Mayo Clinic Cancer Center )
X05306 ( Other Identifier: MPI Protocol )
First Submitted: February 17, 2010
First Posted: February 22, 2010
Results First Submitted: November 7, 2012
Results First Posted: December 5, 2012
Last Update Posted: April 2, 2014