Back to resultsMelphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis (MRD)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dexamethasone
lenalidomide
melphalan
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring primary systemic amyloidosis
Eligibility Criteria
Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Diagnosis of primary systemic amyloidosis
PATIENT CHARACTERISTICS:
- Not pregnant
- Negative pregnancy test
- Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day, therapeutic warfarin, or low molecular weight heparin)
PRIOR CONCURRENT THERAPY:
Recovered from prior therapy
- Permanent or stable side effects/changes allowed
- Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed
- More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or radiotherapy
Exclusion Criteria:
- No secondary or familial amyloidosis
- No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions)
- No prior cumulative doses of oral melphalan > 200 mg
- No more than one prior course of high-dose melphalan with stem cell transplant
Sites / Locations
- Boston University Cancer Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Melphalan Revlimid and Dexamethasone
Arm Description
Melphalan Lenalidomide Dexamethasone
Outcomes
Primary Outcome Measures
Number of Participants With Hematologic Response
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.
Secondary Outcome Measures
Number of Organs Improved or Stable Based on Description Below:
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.
Number of Participants Removed From Study Due to Toxicities
Number of study participants removed from study treatment due to toxicities
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00679367
Brief Title
Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Acronym
MRD
Official Title
A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan and dexamethasone, work in different ways to stop the growth of abnormal plasma cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop the abnormal plasma cells from growing. Giving melphalan together with lenalidomide and dexamethasone may be an effective treatment for primary systemic amyloidosis.
PURPOSE: This phase II trial is studying the side effects and how well giving melphalan together with lenalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
Detailed Description
OBJECTIVES:
Primary
To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone, in terms of toxicity, in patients with primary systemic amyloidosis.
To determine the hematologic response rate in patients treated with this regimen.
Secondary
To assess organ response in patients treated with this regimen.
OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed every 3 months until disease progression and then annually thereafter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
primary systemic amyloidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melphalan Revlimid and Dexamethasone
Arm Type
Experimental
Arm Description
Melphalan Lenalidomide Dexamethasone
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
40 mg once weekly
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Other Intervention Name(s)
revlimid, cc-5013
Intervention Description
10 mg/day D1-21
Intervention Type
Drug
Intervention Name(s)
melphalan
Other Intervention Name(s)
alkeran
Intervention Description
5 mg/m2 D1-4
Primary Outcome Measure Information:
Title
Number of Participants With Hematologic Response
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
Secondary Outcome Measure Information:
Title
Number of Organs Improved or Stable Based on Description Below:
Description
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
Title
Number of Participants Removed From Study Due to Toxicities
Description
Number of study participants removed from study treatment due to toxicities
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DISEASE CHARACTERISTICS:
Diagnosis of primary systemic amyloidosis
PATIENT CHARACTERISTICS:
Not pregnant
Negative pregnancy test
Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day, therapeutic warfarin, or low molecular weight heparin)
PRIOR CONCURRENT THERAPY:
Recovered from prior therapy
Permanent or stable side effects/changes allowed
Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed
More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or radiotherapy
Exclusion Criteria:
No secondary or familial amyloidosis
No multiple myeloma (≥ 30% plasma cells in bone marrow biopsy or lytic bone lesions)
No prior cumulative doses of oral melphalan > 200 mg
No more than one prior course of high-dose melphalan with stem cell transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vaishali Sanchorawala, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston University Cancer Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23144200
Citation
Sanchorawala V, Patel JM, Sloan JM, Shelton AC, Zeldis JB, Seldin DC. Melphalan, lenalidomide and dexamethasone for the treatment of immunoglobulin light chain amyloidosis: results of a phase II trial. Haematologica. 2013 May;98(5):789-92. doi: 10.3324/haematol.2012.075192. Epub 2012 Nov 9.
Results Reference
derived
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Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
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