Clinical trial · Interventional
Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell Transplantation
A Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual and changes in clinical practice
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 dose of chemotherapy to be given so that more plasma cells are killed. Giving a chemoprotective drug such as amifostine may protect kidney cells from the side effects of chemotherapy. PURPOSE: This phase I trial is studying the side effects and best dose of melphalan given together with amifostine in treating patients who are undergoing peripheral stem cell transplant for primary systemic amyloidosis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| 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 (1)
- type
- EXPERIMENTAL
- label
- Amifostine, Melphalan, and Stem Cell Reconstitution
- description
- Amifostine, Melphalan, and Stem Cell Reconstitution. Doses of Melphalan tested included 100 mg/m2 and 120 mg/m2
- interventionNames
- Biological: filgrastim
- Drug: amifostine trihydrate
- Drug: melphalan
- Procedure: bone marrow ablation with stem cell support
- Procedure: peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- Maximum Tolerated Dose
- timeFrame
- Assessed over 30 days
- description
- The maximum tolerated dose is the highest dose level at which fewer than 1 of 3 or 2 of 6 patients experience dose-limiting toxicity, defined as any grade 3 or higher toxicity of any of the following: renal failure, alkaline phosphatase elevation, GI bleeding, and cardiac rhythm disturbances, assessed using NCI Common Toxicity Criteria, version 2.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed amyloidosis
* No secondary familial or localized amyloidosis
* Presence of monoclonal protein by immunoelectrophoresis or immunofixation of serum or urine
* No primary amyloidosis manifested only by carpal tunnel syndrome or purpura
* Amyloid deposits in a plasmacytoma or in bone marrow vessels in an asymptomatic individual not considered an amyloid syndrome
* Amyloid syndromes include any of the following:
* Hepatomegaly
* Cardiomyopathy
* Nephrotic range proteinuria
* Peripheral or autonomic neuropathy
* No multiple myeloma defined by 1 of the following:
* Presence of lytic bone disease
* More than 30% bone marrow plasma cells
PATIENT CHARACTERISTICS:
Age
* 18 to 70
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Platelet count at least 100,000/mm\^3
Hepatic
* See Disease Characteristics
* Total or direct bilirubin no greater than 2.0 mg/dL
* Alkaline phosphatase no greater than 4 times upper limit of normal
Renal
* See Disease Characteristics
* Creatinine less than 3.0 mg/dL
Cardiovascular
* See Disease Characteristics
* Ejection fraction at least 45% by echocardiogram
* No New York Heart Association class III or IV heart disease
* Systolic blood pressure ≥ 90 mmHg
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection
* No other malignancy within the past 5 years except surgically treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or indolent prostate cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior interferon
Chemotherapy
* At least 4 weeks since prior melphalan
* Lifetime total melphalan dose less than 150 mg/m\^2 (based on ideal body weight)
Endocrine therapy
* At least 4 weeks since prior dexamethasone
Radiotherapy
* No prior radiotherapy for amyloidosis
Surgery
* Not specified
Other
* No antihypertensive medications for at least 24 hours prior to, during, and for 1 hour after amifostine administration
* No other prior treatmentReferences
Publications (0)
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