Clinical trial · Interventional
S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis
Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis
NCT00002849CI-TRIAL-00017043completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- induction and maintenance
- description
- dexamethasone induction followed by alpha interferon maintenance
- interventionNames
- Biological: recombinant interferon alfa
- Drug: dexamethasone
Primary outcomes (1)
- measure
- response
- timeFrame
- 10 months
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 specifiedReferences
Publications (2)
- RESULTDhodapkar 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. PMID 15308571
- RESULTDhodapkar 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.