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Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis

Primary Purpose

Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
dexamethasone
melphalan
thalidomide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring primary systemic amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Overall progression-free survival at 2 years

Secondary Outcome Measures

Plasma cell disease response at 3, 12, and 24 months after treatment
Amyloid-related disease response at 12 and 24 months after treatment
Prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL cell clones
Molecular minimal residual disease at 12 and 24 months

Full Information

First Posted
August 4, 2004
Last Updated
January 15, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00089167
Brief Title
Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis
Official Title
Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs such as melphalan, thalidomide, and dexamethasone may be effective in treating patients with primary systemic amyloidosis. PURPOSE: This phase II trial is studying how well giving melphalan together with thalidomide and dexamethasone works in treating patients with primary systemic amyloidosis.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
primary systemic amyloidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
Overall progression-free survival at 2 years
Secondary Outcome Measure Information:
Title
Plasma cell disease response at 3, 12, and 24 months after treatment
Title
Amyloid-related disease response at 12 and 24 months after treatment
Title
Prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL cell clones
Title
Molecular minimal residual disease at 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond L. Comenzo, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Madhav Dhodapkar, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Cohen AD, Zhou P, Reich L, et al.: Risk-adapted intravenous melphalan followed by adjuvant dexamethasone (D) and thalidomide (T) for newly diagnosed patients with Systemic AL Amyloidosis (AL): interim results of a phase II study. [Abstract] Blood 104 (11): A-542, 2004.
Results Reference
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Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis

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