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Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis (MRD)

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ClinicalTrials.gov Identifier: NCT00679367
Recruitment Status : Completed
First Posted : May 16, 2008
Results First Posted : February 20, 2017
Last Update Posted : February 20, 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 Drug: dexamethasone
Drug: lenalidomide
Drug: melphalan
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Melphalan Revlimid and Dexamethasone
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Melphalan Lenalidomide Dexamethasone

dexamethasone: 40 mg once weekly

lenalidomide: 10 mg/day Days 1-21

melphalan: 5 mg/m2 Days 1-4

Period Title: Overall Study
Started 16
Completed 4
Not Completed 12
Reason Not Completed
Adverse Event             7
inability to swallow oral drugs             1
Lack of Efficacy             3
Withdrawal by Subject             1
Arm/Group Title Melphalan Revlimid and Dexamethasone
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Melphalan Lenalidomide Dexamethasone

dexamethasone: 40 mg once weekly

lenalidomide: 10 mg/day Days 1-21

melphalan: 5 mg/m2 Days 1-4

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
  37.5%
>=65 years
10
  62.5%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
10
  62.5%
Male
6
  37.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   6.3%
White
15
  93.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants With Hematologic Response
Hide Description

Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.

Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more.

Time Frame one year
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Hide Analysis Population Description
Participants who completed at least 3 cycles of treatment
Arm/Group Title Melphalan Revlimid and Dexamethasone
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Melphalan Lenalidomide Dexamethasone

dexamethasone: 40 mg once weekly

lenalidomide: 10 mg/day Days 1-21

melphalan: 5 mg/m2 Days 1-4

Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
7
2.Secondary Outcome
Title Number of Organs Improved or Stable Based on Description Below:
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Renal response - > 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency.

Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline.

Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness > 11 mm or a decrease in New York Heart Association heart failure class.

Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus.

Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid.

Peripheral nervous system response – resolution of clinical signs of peripheral neuropathy.

Time Frame one year
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Melphalan Revlimid and Dexamethasone
Hide Arm/Group Description:

Melphalan Lenalidomide Dexamethasone

dexamethasone: 40 mg once weekly

lenalidomide: 10 mg/day Days 1-21

melphalan: 5 mg/m2 Days 1-4

Overall Number of Participants Analyzed 14
Overall Number of Units Analyzed
Type of Units Analyzed: Involved organs
24
Measure Type: Number
Unit of Measure: number of organs stable or improved
10
3.Secondary Outcome
Title Number of Participants Removed From Study Due to Toxicities
Hide Description Number of study participants removed from study treatment due to toxicities
Time Frame One year
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Hide Analysis Population Description
All patients who have had at least one dose of drug.
Arm/Group Title Melphalan Revlimid and Dexamethasone
Hide Arm/Group Description:

Melphalan Lenalidomide Dexamethasone

dexamethasone: 40 mg once weekly

lenalidomide: 10 mg/day days 1-21

melphalan: 5 mg/m2 days 1-4

Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
6
  37.5%
Time Frame 1 year
Adverse Event Reporting Description Toxicity data was collected throughout study participation through 30 days after last dose.
 
Arm/Group Title Melphalan Revlimid and Dexamethasone
Hide Arm/Group Description

Melphalan Lenalidomide Dexamethasone

dexamethasone: 40 mg once weekly

lenalidomide: 10 mg/day Days 1-21

melphalan: 5 mg/m2 Days 1-4

All-Cause Mortality
Melphalan Revlimid and Dexamethasone
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Melphalan Revlimid and Dexamethasone
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Blood and lymphatic system disorders   
thromboembolism  1  1/16 (6.25%)  1
neutropenia  1  6/16 (37.50%)  6
leukopenia  1  5/16 (31.25%)  5
thrombocytopenia  1  4/16 (25.00%)  4
anemia  1  2/16 (12.50%)  2
pancytopenia  1  2/16 (12.50%)  2
Cardiac disorders   
heart failure  1  4/16 (25.00%)  4
chest pressure  1  2/16 (12.50%)  2
hypotension  1  2/16 (12.50%)  2
Eye disorders   
tear duct obstruction/infection  1  1/16 (6.25%)  1
Gastrointestinal disorders   
dehydration  1  1/16 (6.25%)  1
gastrointestinal bleed  1  1/16 (6.25%)  1
General disorders   
fatigue  1  5/16 (31.25%)  5
Infections and infestations   
infection  1  4/16 (25.00%)  4
pneumonia  1  2/16 (12.50%)  2
sepsis  1  2/16 (12.50%)  2
septic shock  1  1/16 (6.25%)  1
Investigations   
Elevated blood urea nitrogen test  1  1/16 (6.25%)  1
increased creatinine  1  2/16 (12.50%)  2
hyponatremia  1  1/16 (6.25%)  1
hyperglycemia  1  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
gout pain  1  1/16 (6.25%)  1
Renal and urinary disorders   
renal failure  1  2/16 (12.50%)  2
Respiratory, thoracic and mediastinal disorders   
pleural effusion - bilateral  1  2/16 (12.50%)  2
dyspnea  1  6/16 (37.50%)  6
Skin and subcutaneous tissue disorders   
rash  1  1/16 (6.25%)  1
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 Revlimid and Dexamethasone
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Blood and lymphatic system disorders   
anemia  1  11/16 (68.75%)  24
edema  1  11/16 (68.75%)  13
leukocytosis  1  1/16 (6.25%)  1
leukopenia  1  11/16 (68.75%)  13
neutropenia  1  3/16 (18.75%)  4
pancytopenia  1  2/16 (12.50%)  3
thrombocytopenia  1  9/16 (56.25%)  9
Cardiac disorders   
atrial fibrillation  1  1/16 (6.25%)  1
bradycardia  1  1/16 (6.25%)  1
congestive heart failure  1  2/16 (12.50%)  2
palpitations  1  2/16 (12.50%)  2
Ear and labyrinth disorders   
hearing loss  1  1/16 (6.25%)  1
tinnitus  1  4/16 (25.00%)  4
Endocrine disorders   
hyperthyroidism  1  2/16 (12.50%)  3
Eye disorders   
blurring  1  4/16 (25.00%)  4
double vision  1  1/16 (6.25%)  1
itchy eyes  1  1/16 (6.25%)  1
Gastrointestinal disorders   
abdominal bloating  1  2/16 (12.50%)  2
abdominal cramping  1  2/16 (12.50%)  2
altered taste  1  3/16 (18.75%)  3
anorexia  1  4/16 (25.00%)  4
aspiration  1  1/16 (6.25%)  1
constipation  1  9/16 (56.25%)  10
diarrhea  1  5/16 (31.25%)  5
dry mouth  1  3/16 (18.75%)  3
dysphagia  1  2/16 (12.50%)  2
early satiety  1  3/16 (18.75%)  3
flatus  1  1/16 (6.25%)  1
hemorrhoida  1  2/16 (12.50%)  2
mouth sores  1  1/16 (6.25%)  1
hemorrhage  1 [1]  1/16 (6.25%)  1
nausea  1  2/16 (12.50%)  2
polydipsia  1  1/16 (6.25%)  1
hemorrhage  1 [2]  1/16 (6.25%)  1
vomiting  1  1/16 (6.25%)  1
weight loss  1  3/16 (18.75%)  3
General disorders   
chills  1  3/16 (18.75%)  3
cold intolerance  1  2/16 (12.50%)  2
decreased performance status  1  2/16 (12.50%)  2
fatigue  1  13/16 (81.25%)  14
fever  1  2/16 (12.50%)  2
insomnia  1  5/16 (31.25%)  5
nocturia  1  3/16 (18.75%)  3
sweats  1  3/16 (18.75%)  3
Infections and infestations   
infection  1 [3]  1/16 (6.25%)  1
infection - upper respiratory  1  2/16 (12.50%)  5
infection - urinary tract  1  2/16 (12.50%)  3
Investigations   
decreased bilirubin  1  1/16 (6.25%)  1
decreased iron  1  1/16 (6.25%)  1
hyperglycemia  1  7/16 (43.75%)  9
hyperkalemia  1  3/16 (18.75%)  5
hypermagnesemia  1  1/16 (6.25%)  1
hypernatremia  1  1/16 (6.25%)  1
hyperphosphatemia  1  1/16 (6.25%)  1
hyperuricemia  1  5/16 (31.25%)  5
hypoalbuminemia  1  6/16 (37.50%)  7
hypocalcemia  1  6/16 (37.50%)  6
hypokalemia  1  5/16 (31.25%)  5
hypomagnesemia  1  1/16 (6.25%)  1
hyponatremia  1  1/16 (6.25%)  1
hypotension  1  2/16 (12.50%)  3
increased alkaline phosphatate  1  3/16 (18.75%)  4
increased Brain natriuretic peptide  1  8/16 (50.00%)  8
Musculoskeletal and connective tissue disorders   
arthritis  1  2/16 (12.50%)  2
gout  1  3/16 (18.75%)  7
hip fracture  1  1/16 (6.25%)  1
joint pain  1  3/16 (18.75%)  3
muscle cramping  1  2/16 (12.50%)  2
muscle weakness  1  1/16 (6.25%)  1
stiffness  1  1/16 (6.25%)  1
Nervous system disorders   
dizziness  1  6/16 (37.50%)  6
headache  1  3/16 (18.75%)  3
peripheral neuropathy  1  7/16 (43.75%)  9
sciatica  1  1/16 (6.25%)  1
tremors  1  2/16 (12.50%)  2
unsteady gait  1  1/16 (6.25%)  1
weakness  1  6/16 (37.50%)  6
Psychiatric disorders   
anxiety  1  3/16 (18.75%)  3
confusion  1  2/16 (12.50%)  2
depression  1  3/16 (18.75%)  3
mental disturbance  1  1/16 (6.25%)  1
Renal and urinary disorders   
decreased renal function  1  1/16 (6.25%)  1
dysuria  1  1/16 (6.25%)  1
increased creatinine  1  6/16 (37.50%)  7
urinary frequency  1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
cough  1  4/16 (25.00%)  4
dyspnea  1  12/16 (75.00%)  12
hoarseness  1  5/16 (31.25%)  5
rhinorrhea  1  2/16 (12.50%)  2
sore throat  1  1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
dry skin  1  2/16 (12.50%)  2
bruising  1  5/16 (31.25%)  5
pruritis  1  2/16 (12.50%)  2
rash  1  2/16 (12.50%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
mucosal bleeding
[2]
rectal bleed
[3]
tooth abscess
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: NCT00679367     History of Changes
Other Study ID Numbers: CDR0000595759
RV-AMYL-PI-0219 ( Other Grant/Funding Number: Celgene )
BUMC-H-26320 ( Other Identifier: Boston University Medical Center IRB )
First Submitted: May 14, 2008
First Posted: May 16, 2008
Results First Submitted: September 9, 2016
Results First Posted: February 20, 2017
Last Update Posted: February 20, 2017