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Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease

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ClinicalTrials.gov Identifier: NCT00520767
Recruitment Status : Active, not recruiting
First Posted : August 27, 2007
Results First Posted : March 30, 2015
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jeffrey Zonder, Barbara Ann Karmanos Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Systemic Amyloidosis
Light Chain Deposition Disease
Interventions Drug: bortezomib
Drug: dexamethasone
Drug: melphalan
Genetic: microarray analysis
Other: flow cytometry
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Melphalan, Dexamethasone, Bortezomib,
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Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4

bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22

dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23

melphalan: Melphalan 9 mg/m2/day days 1-4

microarray analysis: ≤28 days prior to enrollment

flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.

laboratory biomarker analysis: ≤28 days prior to enrollment

quality-of-life assessment: Start of each cycle

Period Title: Overall Study
Started 35
Completed 33
Not Completed 2
Reason Not Completed
Death             2
Arm/Group Title Melphalan, Dexamethasone, Bortezomib,
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Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4

bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22

dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23

melphalan: Melphalan 9 mg/m2/day days 1-4

microarray analysis: ≤28 days prior to enrollment

flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.

laboratory biomarker analysis: ≤28 days prior to enrollment

quality-of-life assessment: Start of each cycle

Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
64
(47 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
15
  42.9%
Male
20
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title Complete Hematologic Response
Hide Description [Not Specified]
Time Frame Up to 12 months
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Hide Analysis Population Description
Individuals evaluable for response
Arm/Group Title Melphalan, Dexamethasone, Bortezomib,
Hide Arm/Group Description:

Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4

bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22

dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23

melphalan: Melphalan 9 mg/m2/day days 1-4

microarray analysis: ≤28 days prior to enrollment

flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.

laboratory biomarker analysis: ≤28 days prior to enrollment

quality-of-life assessment: Start of each cycle

Overall Number of Participants Analyzed 33
Overall Number of Units Analyzed
Type of Units Analyzed: Individuals
33
Measure Type: Number
Unit of Measure: participants
16
2.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Day 1 of Each Cycle and every 12 weeks after last treatment cycle
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Time to Treatment Failure
Hide Description [Not Specified]
Time Frame Day 1 of Each Cycle
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change in Quality of Life From Baseline as Assessed by the Functional Assessment of Cancer Therapy-Neurotoxicity Questionnaire.
Hide Description [Not Specified]
Time Frame At the start of each cycle
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Organ Response Rate (OrR)
Hide Description [Not Specified]
Time Frame Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Toxicity, Including Neurotoxicity
Hide Description [Not Specified]
Time Frame Day 1 of Each Cycle
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Overall Hematologic Response Rate (OHR)
Hide Description [Not Specified]
Time Frame Beginning of cycles 4, 8, 12, 16 and 20, at follow up and end of study.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Melphalan, Dexamethasone, Bortezomib,
Hide Arm/Group Description

Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4

bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22

dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23

melphalan: Melphalan 9 mg/m2/day days 1-4

microarray analysis: ≤28 days prior to enrollment

flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.

laboratory biomarker analysis: ≤28 days prior to enrollment

quality-of-life assessment: Start of each cycle

All-Cause Mortality
Melphalan, Dexamethasone, Bortezomib,
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Melphalan, Dexamethasone, Bortezomib,
Affected / at Risk (%) # Events
Total   12/35 (34.29%)    
Blood and lymphatic system disorders   
thrombocytopenia  1  2/35 (5.71%)  2
Edema  1  2/35 (5.71%)  2
Cardiac disorders   
Congestive Heart Failure  1  1/35 (2.86%)  1
Hypotension  1  1/35 (2.86%)  1
Ventricular Arrhythmia  1  2/35 (5.71%)  2
Hypertension  1  2/35 (5.71%)  2
cardiac Arrhythmia  1  1/35 (2.86%)  1
Gastrointestinal disorders   
Dehydration  1  2/35 (5.71%)  2
Nausea  1  1/35 (2.86%)  1
Vomiting  1  1/35 (2.86%)  1
General disorders   
Death  1  2/35 (5.71%)  2
Pain-chest wall  1  1/35 (2.86%)  1
Infections and infestations   
Infection with Normal ANC-Lung (pneumonia)  1  2/35 (5.71%)  2
Infection with Normal ANC-Catheter related  1  1/35 (2.86%)  1
Infection with Normal ANC-Skin (cellulitis)-shingles  1  1/35 (2.86%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  1/35 (2.86%)  1
Hyponatremia  1  1/35 (2.86%)  1
Creatinine  1  2/35 (5.71%)  2
Nervous system disorders   
syncope  1  1/35 (2.86%)  1
Pain-Headache  1  2/35 (5.71%)  2
Psychiatric disorders   
Mental Status Change  1  2/35 (5.71%)  2
Renal and urinary disorders   
Renal Failure  1  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/35 (5.71%)  2
Hypoxia  1  2/35 (5.71%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Melphalan, Dexamethasone, Bortezomib,
Affected / at Risk (%) # Events
Total   3/35 (8.57%)    
Blood and lymphatic system disorders   
Hemoglobin  1  2/35 (5.71%)  2
Gastrointestinal disorders   
Constipation  1  2/35 (5.71%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Mix of previously treated & newly diagnosed pts (populations which may have different prognoses), plus the relatively small trial size limit conclusions one can draw re: relative efficacy of MDV (vs CyBorD or Mel-Dex, for example)
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: Jeffrey Zonder, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: 313-576-8732
EMail: zonderj@karmanos.org
Layout table for additonal information
Responsible Party: Jeffrey Zonder, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00520767     History of Changes
Other Study ID Numbers: CDR0000555016
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2006-132 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
MILLENNIUM-WSU-2006-132
WSU-HIC-060907M1F ( Other Identifier: Wayne State University - Human Investigation Committee )
First Submitted: August 24, 2007
First Posted: August 27, 2007
Results First Submitted: March 18, 2015
Results First Posted: March 30, 2015
Last Update Posted: February 22, 2019