Clinical trial · Interventional
Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis
A Phase II Trial of Tandem Transplantation in AL Amyloidosis
NCT00075621CI-TRIAL-00047204completedPhase 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: Autologous stem cell transplantation may be effective treatment for primary systemic (AL) amyloidosis. PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell transplantation works in treating patients with primary systemic (AL) 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| filgrastim | Drug | Filgrastim | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- tandem transplant
- description
- Drug: filgrastim 16 mg/kg/day for 3 days prior to stem cell collection, through day before last collection Drug: melphalan 200 mg/kg over 2 days Procedure/Surgery: autologous peripheral blood stem cell transplantation autologous peripheral blood stem cell transplantation
- interventionNames
- Drug: filgrastim
- Drug: melphalan
- Procedure: autologous peripheral blood stem cell transplantation
Primary outcomes (1)
- measure
- safety
- timeFrame
- 100 days, 6 months, and annual
Secondary outcomes (1)
- measure
- Efficacy
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed AL amyloidosis, meeting 1 of the following criteria:
* Plasma cell dyscrasia, evidenced by 1 of the following:
* Monoclonal protein in the serum or urine by immunofixation electrophoresis
* Plasmacytosis of the bone marrow with monoclonal staining for kappa or lambda light chain isotype
* Macroglossia with at least 1 other site having biopsy proven amyloidosis and absence of a mutant transthyretin is ruled out
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Performance status
* SWOG 0-2
Life expectancy
* At least 1 year
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* LVEF ≥ 45% by MUGA or echocardiogram
Pulmonary
* DLCO ≥ 50%
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Able to tolerate 2 courses of high-dose therapy
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Prior alkylating agent chemotherapy allowed provided there is no morphologic or cytogenetic evidence of myelodysplastic syndromes
* Prior total cumulative oral melphalan dose \< 300 mg
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 4 weeks since prior cytotoxic therapy and recovered
Exclusion Criteria:
* No senile, secondary, localized, dialysis-related, or familial amyloidosis
* No overt multiple myeloma (e.g., greater than 30% bone marrow plasmacytosis, extensive \[more than 2\] lytic lesions, hypercalcemia)
Cardiovascular
* No myocardial infarction within the past 6 months
* No congestive heart failure
* No arrhythmia refractory to therapy
* No evidence of symptomatic transient ischemic attacks or strokes
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remissionReferences
Publications (0)
Data not yet available
No reference posted for this study.