Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
MRD
A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis
3 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 multiple-myeloma
Started May 2008
Longer than P75 for phase_2 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 14, 2008
CompletedFirst Posted
Study publicly available on registry
May 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
February 20, 2017
CompletedFebruary 20, 2017
December 1, 2016
7 years
May 14, 2008
September 9, 2016
December 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
one year
Secondary Outcomes (2)
Number of Organs Improved or Stable Based on Description Below:
one year
Number of Participants Removed From Study Due to Toxicities
One year
Study Arms (1)
Melphalan Revlimid and Dexamethasone
EXPERIMENTALMelphalan Lenalidomide Dexamethasone
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston University Cancer Research Center
Boston, Massachusetts, 02118, United States
Related Publications (1)
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.
PMID: 23144200DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vaishali Sanchorawala
- Organization
- Boston Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Vaishali Sanchorawala, MD
Boston Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 14, 2008
First Posted
May 16, 2008
Study Start
May 1, 2008
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
February 20, 2017
Results First Posted
February 20, 2017
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share