Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
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

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
Not Provided
Not Provided
 
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
Not Provided
Not Provided
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