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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall progression-free survival at 2 years

Safety Issue:

No

Principal Investigator

Raymond L. Comenzo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

02-031

NCT ID:

NCT00089167

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • primary systemic amyloidosis
  • Amyloidosis
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021