S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
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| ClinicalTrials.gov Identifier: NCT00002849 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : March 6, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Biological: recombinant interferon alfa Drug: dexamethasone | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 93 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis |
| Study Start Date : | November 1996 |
| Actual Primary Completion Date : | December 1998 |
| Actual Study Completion Date : | July 2000 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: induction and maintenance
dexamethasone induction followed by alpha interferon maintenance
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Biological: recombinant interferon alfa
first 2 years
Other Name: alpha interferon Drug: dexamethasone 40 mg*/d PO 1 - 4, 9 - 12, 17-20 q 35 days for 3 cycles*
Other Name: decadron |
- response [ Time Frame: 10 months ]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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002849
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| Study Chair: | Laura F. Hutchins, MD | University of Arkansas | |
| Study Chair: | Richard A. Larson, MD | University of Chicago |
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002849 |
| Other Study ID Numbers: |
S9628 S9628 ( Other Identifier: SWOG ) CLB-9790 ( Other Identifier: CALGB ) CLB-S9628 ( Other Identifier: CALGB ) U10CA032102 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | March 6, 2015 |
| Last Verified: | March 2015 |
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primary systemic amyloidosis |
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Multiple Myeloma Immunoglobulin Light-chain Amyloidosis Amyloidosis Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders |
Immune System Diseases Proteostasis Deficiencies Metabolic Diseases Interferons Interferon-alpha Dexamethasone Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |