Clinical trial · Interventional
High-Dose Melphalan Followed by Peripheral Stem Cell Transplant in Treating Patients With Amyloidosis
Autologous Peripheral Blood Stem Cell Transplantation With High Dose Melphalan For Treatment Of Primary Amyloidosis (AL)
- 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: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a peripheral stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly. PURPOSE: This phase II trial is studying how well giving high-dose melphalan together with peripheral stem cell transplant works in treating patients with primary amyloidosis or amyloidosis associated with multiple myeloma.
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 and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bone marrow ablation with stem cell support | Procedure | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Overall survival
- measure
- Time to clinical progression of amyloid symptoms
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Primary amyloidosis diagnosed by appropriate amyloid stains or electromicroscopy of abdominal fat, bone marrow, or other target tissues * Pathology reviewed by Temple University * Amyloidosis secondary to any stage of multiple myeloma allowed provided plasma cell concentration in bone marrow is less than 15% * No amyloidosis secondary to rheumatoid arthritis or chronic infection * No familial amyloidosis PATIENT CHARACTERISTICS: Age: * 16 to 65 Performance status: * Karnofsky 80-100% Hematopoietic: * Not specified Hepatic: * Liver function tests less than twice normal * No active liver disease Renal: * Creatinine clearance greater than 50 mL/min * Nephrotic syndrome allowed Cardiovascular: * Cardiac evaluation required in patients with left ventricular ejection fraction less than 45% by echocardiogram or MUGA * No poorly controlled hypertension Pulmonary: * FEV\_1 and DLCO greater than 50% of predicted, or pulmonary evaluation required * No chronic obstructive pulmonary disease Other: * No history of serious coagulopathy, hemorrhage, or bleeding * No active infection * No other serious comorbid disease (e.g., poorly controlled diabetes) * No pregnant women * Adequate contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * More than 12 monthly cycles of prior alkylating agent chemotherapy discouraged Endocrine therapy: * Corticosteroids discontinued at least 6 weeks prior to transplantation Radiotherapy: * No prior radiotherapy Surgery: * Not specified
References
Publications (0)
Data not yet available