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Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis

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ClinicalTrials.gov Identifier: NCT00458822
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Drug: bortezomib
Drug: dexamethasone
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
Period Title: Overall Study
Started 40
Completed 40
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
Overall Number of Baseline Participants 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants
57
(38 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants
Female
23
  57.5%
Male
17
  42.5%
1.Primary Outcome
Title Hematologic and Organ Response
Hide Description patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.
Time Frame 2-3 months post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
Complete Hematologic Response 11
Partial Response 7
Stable Disease 18
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   20/40 (50.00%)    
Blood and lymphatic system disorders   
Coagulation, other  1  2/40 (5.00%)  2
Platelets  1  4/40 (10.00%)  4
Cardiac disorders   
Atrial fibrillation  1  1/40 (2.50%)  1
Cardiac Arrhythmia, other  1  1/40 (2.50%)  1
Cardiac General, other  1  6/40 (15.00%)  6
Hypotension  1  4/40 (10.00%)  5
Restrictive cardiomyopathy  1  1/40 (2.50%)  2
Supraventricular tachycardia  1  1/40 (2.50%)  1
Ventricular arrhythmia- Ventricular tachycardia  1  1/40 (2.50%)  1
Gastrointestinal disorders   
Dehydration  1  1/40 (2.50%)  2
Hemorrhage, Upper GI NOS  1  1/40 (2.50%)  1
Nausea  1  1/40 (2.50%)  1
General disorders   
Arthritis (non-septic)  1  1/40 (2.50%)  1
Conduction Abnormality NOS  1  1/40 (2.50%)  1
Death not associated with CTCAE term- Death NOS  1  3/40 (7.50%)  3
Febrile neutropenia  1  1/40 (2.50%)  1
Fever (in the absence of neutropenia)  1  1/40 (2.50%)  1
Hemorrhage/Bleeding, other  1  1/40 (2.50%)  1
Hypoxia  1  1/40 (2.50%)  1
Ocular/Visual - Other  1  1/40 (2.50%)  1
Infections and infestations   
Neutrophil-Pneumonia (lung)  1  2/40 (5.00%)  2
Neutrophil-Up airway NOS  1  1/40 (2.50%)  1
Infection, other  1  5/40 (12.50%)  5
Metabolism and nutrition disorders   
Sodium, low (hyponatremia)  1  1/40 (2.50%)  1
Nervous system disorders   
CNS cerebrovascular ischemia  1  1/40 (2.50%)  1
Syncope (fainting)  1  4/40 (10.00%)  4
Vasovagal episode  1  2/40 (5.00%)  2
Renal and urinary disorders   
Renal failure  1  3/40 (7.50%)  3
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  1  3/40 (7.50%)  4
Pulm/upper respiratory - Other  1  1/40 (2.50%)  1
Thrombosis/thrombus/embolism  1  2/40 (5.00%)  2
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  1/40 (2.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%) # Events
Total   40/40 (100.00%)    
Blood and lymphatic system disorders   
ALT, SGPT  1  11/40 (27.50%) 
AST, SGOT  1  6/40 (15.00%) 
Hemoglobin  1  37/40 (92.50%) 
Prothrombin Time international normalized ratio  1  10/40 (25.00%) 
Leukocytes (total WBC)  1  38/40 (95.00%) 
Lymphopenia  1  39/40 (97.50%) 
Neutrophils/granulocytes  1  36/40 (90.00%) 
Platelets  1  39/40 (97.50%) 
Partial thromboplastin time  1  5/40 (12.50%) 
Gastrointestinal disorders   
Constipation  1  9/40 (22.50%) 
Dehydration  1  2/40 (5.00%) 
Diarrhea  1  3/40 (7.50%) 
Distension/bloating, abdominal  1  3/40 (7.50%) 
Nausea  1  4/40 (10.00%) 
General disorders   
Cholesterol,high(hypercholestremia)  1  6/40 (15.00%) 
Cushingoid appearance  1  2/40 (5.00%) 
Fatigue (asthenia, lethargy, malaise)  1  15/40 (37.50%) 
Lipase  1  2/40 (5.00%) 
Weight gain  1  2/40 (5.00%) 
Infections and infestations   
Infection, other  1  2/40 (5.00%) 
Metabolism and nutrition disorders   
Albumin, low (hypoalbuminemia)  1  31/40 (77.50%) 
Alkaline phosphatase  1  9/40 (22.50%) 
Bicarbonate, serum-low  1  5/40 (12.50%) 
Bilirubin (hyperbilirubinemia)  1  6/40 (15.00%) 
Creatinine  1  22/40 (55.00%) 
Glucose, high (hyperglycemia)  1  27/40 (67.50%) 
Glucose, low (hypoglycemia)  1  12/40 (30.00%) 
Magnesium, high (hypermagnesemia)  1  5/40 (12.50%) 
Magnesium, low (hypomagnesemia)  1  2/40 (5.00%) 
Phosphate, low (hypophosphatemia)  1  18/40 (45.00%) 
Potassium, high (hyperkalemia)  1  9/40 (22.50%) 
Potassium, low (hypokalemia)  1  14/40 (35.00%) 
Sodium, low (hyponatremia)  1  12/40 (30.00%) 
Nervous system disorders   
Neuropathy: sensory  1  10/40 (25.00%) 
Pain - Neuralgia/peripheral nerve  1  7/40 (17.50%) 
Syncope (fainting)  1  3/40 (7.50%) 
Renal and urinary disorders   
Renal failure  1  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/40 (7.50%) 
Dyspnea (shortness of breath)  1  4/40 (10.00%) 
Skin and subcutaneous tissue disorders   
Pruritus/itching  1  2/40 (5.00%) 
Rash/desquamation  1  2/40 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-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: Dr. Heather Landau
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-8808
EMail: LandauH@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00458822     History of Changes
Other Study ID Numbers: 07-006
MSKCC-07006
First Submitted: April 9, 2007
First Posted: April 11, 2007
Results First Submitted: January 4, 2016
Results First Posted: August 10, 2016
Last Update Posted: August 10, 2016