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Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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Trial Information

Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis


OBJECTIVES:

- Evaluate M protein and organ dysfunction responses and overall and progression-free
survival in patients with primary systemic amyloidosis treated with
dexamethasone/interferon alfa.

- Identify prognostic factors that may relate to response and overall survival in these
patients.

- Evaluate the qualitative and quantitative toxic effects of this regimen.

OUTLINE: Patients are stratified by prior amyloidosis treatment (yes vs no).

All patients receive induction therapy with oral dexamethasone on days 1-4, 9-12, and 17-20
every 35 days for a total of 3 courses.

Maintenance therapy begins within 5-8 weeks (within 10 weeks if patients undergo stem cell
harvest) of initiation of the third course of induction, as follows: oral dexamethasone for
4 days every 4 weeks; and subcutaneous interferon alfa 3 times per week. Patients who
achieved less than a 50% reduction in serum M protein or urinary Bence-Jones protein and who
experienced less than grade 3 toxicity during induction receive 3 additional courses of
pulse dexamethasone concurrently with entry to maintenance therapy and the initiation of
interferon alfa.

Combination therapy is continued until 2 years from entry; thereafter, interferon is
administered alone for at least 3 years, toxicity permitting. Patients with stable disease
after 5 years of therapy may discontinue interferon alfa at the discretion of the treating
physician.

Patients are followed every 6 months for 2 years and yearly thereafter.

PROJECTED ACCRUAL: A total of 100 patients (50 with prior melphalan/prednisone or
iododoxorubicin treatment and 50 without) will be entered over 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically diagnosed primary systemic amyloidosis based on the following:

- Deposition of fibrillary protein with Congo red positive stain or characteristic
electron microscopic appearance

- Monoclonal light chain protein (Bence-Jones protein) in serum or urine or
immunohistochemical studies

- Evidence of tissue involvement other than carpal tunnel syndrome

- Diagnostic histologic material available for central pathology review

- Confirmation of tissue diagnosis at all sites of organ dysfunction
encouraged

- No senile, secondary, localized, dialysis-related, or familial amyloidosis

- No known therapy-related myelodysplasia

PATIENT CHARACTERISTICS:

Age:

- Adult

Performance status:

- SWOG 0-4

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- No NYHA class IV status

Other:

- No uncontrolled diabetes

- No active peptic ulcer disease

- No medical condition that precludes high-dose steroids

- No second malignancy within 5 years except:

- Adequately treated nonmelanomatous skin cancer

- In situ cervical cancer

- Adequately treated stage I/II cancer in complete remission

- Not pregnant or nursing

- Effective contraception required of fertile patients

- Blood/body fluid analyses within 14 days prior to registration

- Imaging/exams for tumor measurement within 28 days prior to registration

- Other screening exams within 42 days prior to registration

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior interferon alfa

Chemotherapy

- Prior melphalan allowed, but recovered from effects

- At least 4 weeks since cytotoxic therapy and recovered

Endocrine therapy

- Prior prednisone allowed, but recovered from effects

- At least 4 weeks since prior glucocorticoids

- No prior dexamethasone

- No planned or concurrent dexamethasone or other therapy for primary systemic
amyloidosis

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response

Outcome Description:

50% or more reduction in quantitative immunoglobulin, or if the patient has light-chain disease only, a 50% or more reduction in the urine M-component (Bence-Jones protein).

Outcome Time Frame:

10 months

Safety Issue:

No

Principal Investigator

Laura F. Hutchins, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arkansas

Authority:

United States: Federal Government

Study ID:

CDR0000065092

NCT ID:

NCT00002849

Start Date:

November 1996

Completion Date:

July 2000

Related Keywords:

  • Multiple Myeloma
  • primary systemic amyloidosis
  • Amyloidosis
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
North Shore University HospitalManhasset, New York  11030
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Weill Medical College of Cornell UniversityNew York, New York  10021
Lifespan: The Miriam HospitalProvidence, Rhode Island  02906