Completed

Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Immunoglobulin Light-chain Amyloidosis+16

+ Amyloidosis

+ Blood Protein Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2002
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2002

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the 2-year and overall progression-free survival of patients with newly diagnosed, previously untreated primary systemic (AL) amyloidosis treated with risk-adapted melphalan followed by thalidomide and dexamethasone. Secondary * Determine plasma cell disease response in these patients at 3, 12, and 24 months after treatment with this regimen. * Determine amyloid-related disease response in these patients at 12 and 24 months after treatment with this regimen. * Determine the prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL plasma cell clones in patients treated with this regimen. * Determine whether there is molecular minimal residual disease at 12 and 24 months in patients achieving a complete hematologic response after treatment with this regimen. OUTLINE: Patients are stratified according to the extent of amyloid-related disease (low-risk vs high-risk). * High-risk disease: Patients receive 2 courses of low-dose melphalan IV, dexamethasone, and filgrastim (G-CSF). After 3 months, patients receive thalidomide and dexamethasone if plasma cell disease persists. * Low-risk disease: Patients receive 1 course of high-dose melphalan IV and G-CSF. Patients then receive thalidomide and dexamethasone as in high-risk disease regimen. Patients are followed at 3, 12, and 24 months. PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.

Official TitleRisk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis 
NCT00089167
Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immunoglobulin Light-chain AmyloidosisAmyloidosisBlood Protein DisordersCardiovascular DiseasesHematologic DiseasesHemorrhagic DisordersImmune System DiseasesImmunoproliferative DisordersLymphoproliferative DisordersMetabolic DiseasesMultiple MyelomaNeoplasmsNeoplasms by Histologic TypeParaproteinemiasPlasmacytomaVascular DiseasesHemostatic DisordersNeoplasms, Plasma CellProteostasis Deficiencies

Criteria

DISEASE CHARACTERISTICS: * Diagnosis of primary systemic (AL) amyloidosis within the past 12 months * High- or low-risk disease, determined by the extent of systemic organ involvement with disease and patient age PATIENT CHARACTERISTICS: Age * 18 and over Performance status * SWOG 0-3 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No New York Heart Association class III or IV congestive heart failure * No restrictive cardiomyopathy requiring oxygen * No myocardial infarction within the past 6 months * No symptomatic cardiac arrhythmia within the past 60 days Other * No other active malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for AL amyloidosis Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * No other prior or concurrent therapy for AL amyloidosis

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Memorial Sloan-Kettering Cancer Center

New York, United StatesSee the location
CompletedOne Study Center