NCT00679367 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2017-02-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Hematologic Response

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outcome · POSTED

Number of Organs Improved or Stable Based on Description Below:

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outcome · POSTED

Number of Participants Removed From Study Due to Toxicities

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Melphalan Lenalidomide Dexamethasone
intervention Names
Drug: dexamethasone
Drug: lenalidomide
Drug: melphalan
label
Melphalan Revlimid and Dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
Melphalan Revlimid and Dexamethasone
description
40 mg once weekly
name
dexamethasone
other Names
Decadron
type
DRUG
arm Group Labels
Melphalan Revlimid and Dexamethasone
description
10 mg/day D1-21
name
lenalidomide
other Names
revlimid, cc-5013
type
DRUG
arm Group Labels
Melphalan Revlimid and Dexamethasone
description
5 mg/m2 D1-4
name
melphalan
other Names
alkeran
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 16
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
measure
Number of Participants With Hematologic Response
time Frame
one year

secondary Outcomes

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.
measure
Number of Organs Improved or Stable Based on Description Below:
time Frame
one year
description
Number of study participants removed from study treatment due to toxicities
measure
Number of Participants Removed From Study Due to Toxicities
time Frame
One year

Full 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.

Source references

references

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.
pmid
23144200
type
DERIVED

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice