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S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
recombinant interferon alfa
dexamethasone
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring primary systemic amyloidosis

Eligibility Criteria

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

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

Sites / Locations

  • Rebecca and John Moores UCSD Cancer Center
  • Veterans Affairs Medical Center - San Francisco
  • CCOP - Christiana Care Health Services
  • Lombardi Cancer Center
  • Walter Reed Army Medical Center
  • CCOP - Mount Sinai Medical Center
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
  • University of Chicago Cancer Research Center
  • Holden Comprehensive Cancer Center
  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  • Dana-Farber Cancer Institute
  • University of Massachusetts Memorial Medical Center - University Campus
  • Veterans Affairs Medical Center - Minneapolis
  • University of Minnesota Cancer Center
  • Veterans Affairs Medical Center - Columbia (Truman Memorial)
  • Ellis Fischel Cancer Center - Columbia
  • Barnes-Jewish Hospital
  • University of Nebraska Medical Center
  • CCOP - Southern Nevada Cancer Research Foundation
  • Norris Cotton Cancer Center
  • Veterans Affairs Medical Center - Buffalo
  • Roswell Park Cancer Institute
  • CCOP - North Shore University Hospital
  • North Shore University Hospital
  • Memorial Sloan-Kettering Cancer Center
  • Weill Medical College of Cornell University
  • Mount Sinai Medical Center, NY
  • State University of New York - Upstate Medical University
  • Veterans Affairs Medical Center - Syracuse
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • Lineberger Comprehensive Cancer Center, UNC
  • Veterans Affairs Medical Center - Durham
  • Duke Comprehensive Cancer Center
  • CCOP - Southeast Cancer Control Consortium
  • Comprehensive Cancer Center at Wake Forest University
  • Arthur G. James Cancer Hospital - Ohio State University
  • Lifespan: The Miriam Hospital
  • Vermont Cancer Center
  • Veterans Affairs Medical Center - White River Junction
  • MBCCOP - Massey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

induction and maintenance

Arm Description

dexamethasone induction followed by alpha interferon maintenance

Outcomes

Primary Outcome Measures

response
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).

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 5, 2015
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B
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1. Study Identification

Unique Protocol Identification Number
NCT00002849
Brief Title
S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
Official Title
Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
December 1998 (Actual)
Study Completion Date
July 2000 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Cancer and Leukemia Group B

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Chemotherapy plus interferon alfa may be effective for primary systemic amyloidosis. PURPOSE: Phase II trial to study the effectiveness of dexamethasone plus interferon alfa in treating patients who have primary systemic amyloidosis.
Detailed Description
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
induction and maintenance
Arm Type
Experimental
Arm Description
dexamethasone induction followed by alpha interferon maintenance
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Other Intervention Name(s)
alpha interferon
Intervention Description
first 2 years
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
decadron
Intervention Description
40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles*
Primary Outcome Measure Information:
Title
response
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).
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura F. Hutchins, MD
Organizational Affiliation
University of Arkansas
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard A. Larson, MD
Organizational Affiliation
University of Chicago
Official's Role
Study Chair
Facility Information:
Facility Name
Rebecca and John Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Veterans Affairs Medical Center - San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5000
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago (Westside Hospital)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Veterans Affairs Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Veterans Affairs Medical Center - Columbia (Truman Memorial)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
CCOP - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center, NY
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Veterans Affairs Medical Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13217
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
Lifespan: The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Vermont Cancer Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401-3498
Country
United States
Facility Name
Veterans Affairs Medical Center - White River Junction
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
Facility Name
MBCCOP - Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15308571
Citation
Dhodapkar MV, Hussein MA, Rasmussen E, Solomon A, Larson RA, Crowley JJ, Barlogie B; United States Intergroup Trial Southwest Oncology Group. Clinical efficacy of high-dose dexamethasone with maintenance dexamethasone/alpha interferon in patients with primary systemic amyloidosis: results of United States Intergroup Trial Southwest Oncology Group (SWOG) S9628. Blood. 2004 Dec 1;104(12):3520-6. doi: 10.1182/blood-2004-05-1924. Epub 2004 Aug 12.
Results Reference
result
Citation
Dhodapkar M, Jacobson J, Hussein M, et al.: High dose dexamethasone (Dex) with maintenance Dex / alpha interferon leads to improved survival in patients with primary systemic amyloidosis: results of US Intergroup Trial Southwest Oncology Group (SWOG) S9628. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2278, 2003.
Results Reference
result

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S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis

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