Clinical trial · Interventional
Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis
Study of High-Dose Melphalan and Autologous Stem Cell Transplantation in
NCT00017680CI-TRIAL-00001525completedPhase 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)
OBJECTIVES: I. Determine the response, disease-free survival, and overall survival of patients with primary light chain amyloidosis treated with high-dose melphalan and autologous stem cell transplantation. II. Determine the toxicity of this regimen in these patients.
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 |
|---|---|---|---|
| Amyloidosis | Amyloidosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response, disease-free survial, and overall survial; response will be determined by the change in organ dysfunction
Secondary outcomes (1)
- measure
- Toxicity of high dose chemotherapy regimen
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
PROTOCOL ENTRY CRITERIA: Disease Characteristics * Histologically confirmed primary amyloidosis * Ineligible for other high priority national or international study Prior/Concurrent Therapy * Biologic therapy: Concurrent participation in gene therapy trials allowed * Chemotherapy: Prior chemotherapy allowed No other concurrent chemotherapy * Endocrine therapy: No concurrent steroids unless given with amphotericin B, for adrenal failure, or for septic shock No concurrent hormones except for non-disease-related conditions (e.g., insulin for diabetes) * Other: No concurrent barbiturates or acetaminophen Concurrent participation in supportive care trials allowed Patient Characteristics * Performance status: ECOG 0-3 * Hepatic: Bilirubin less than 2 times normal * Renal: Creatinine less than 2.5 mg/dL OR On stable hemodialysis * Pulmonary: DLCO at least 60% predicted OR Clearance by pulmonologist * Other: HIV negative
References
Publications (0)
Data not yet available
No reference posted for this study.