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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00089167
First received: August 4, 2004
Last updated: January 15, 2013
Last verified: January 2013
History of Changes

August 4, 2004
January 15, 2013
May 2002
December 2007   (final data collection date for primary outcome measure)
Overall progression-free survival at 2 years [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00089167 on ClinicalTrials.gov Archive Site
  • Plasma cell disease response at 3, 12, and 24 months after treatment [ Designated as safety issue: No ]
  • Amyloid-related disease response at 12 and 24 months after treatment [ Designated as safety issue: No ]
  • Prognostic significance of immunoglobulin light-chain variable-region germline gene expression by AL cell clones [ Designated as safety issue: No ]
  • Molecular minimal residual disease at 12 and 24 months [ Designated as safety issue: No ]
Not Provided
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Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis
Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis

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.

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.
Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Biological: filgrastim
  • Drug: dexamethasone
  • Drug: melphalan
  • Drug: thalidomide
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00089167
02-031, MSKCC-02031
Not Provided
Not Provided
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Raymond L. Comenzo, MD Memorial Sloan-Kettering Cancer Center
Principal Investigator: Madhav Dhodapkar, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP