TriangleNCT00075608 · REGISTRY CONDITION SEARCH
2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- TERMINATED
- Registry last update
- 2017-01-27
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 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 autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- Inclusion criteria: DISEASE CHARACTERISTICS: * Histologically confirmed AL amyloidosis * Persistent or recurrent disease after 1 course of prior high-dose chemotherapy * Previously treated with autologous stem cell transplantation * Significant initial improvement in organ function after prior high-dose melphalan, defined by at least 1 of the following: * Complete hematologic remission (e.g., absence of monoclonal spike by immunofixation in serum and urine AND less then 5% plasma cells in bone marrow with no clonal predominance) OR partial hematologic response (e.g., any decrease in serum or urine monoclonal protein OR decrease in bone marrow plasmacytosis) * Greater than 50% reduction in proteinuria with preservation of creatinine clearance * Greater than 50% reduction in alkaline phosphatase OR at least 2 cm decrease in liver size by physical exam * Subjective neurologic improvement, as confirmed by neurologist * Cardiac stabilization of disease confirmed by echocardiography defined as less than 2 mm increase in mean wall thickness and/or less than 20 g increase in left ventricular mass * Improvement in performance status\* NOTE: \*This criteria alone does not constitute significant improvement in organ function * Prior stem cell yield must have been ≥ 2 x 10\^6 CD34+ cells/kg PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics * No chemotherapy after first transplantation Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified PATIENT CHARACTERISTICS: Age * 18 to 65 Performance status * Southwest Oncology Group- 0-2 Life expectancy * More than 6 months Hematopoietic * See Disease Characteristics Hepatic * See Disease Characteristics Renal * See Disease Characteristics Cardiovascular * See Disease Characteristics * Left ventricular ejection fraction ≥ 45% by multiple gated acquisition scan or echocardiogram Pulmonary * diffusing capacity of lung for carbon monoxide ≥ 50% Exclusion Criteria: * No myelodysplastic syndromes * No abnormal bone marrow cytogenetics Other * Not pregnant or nursing * Fertile patients must use effective contraception * Acceptable toxicity from first transplantation, confirmed by the transplant team * HIV negative * No other concurrent malignancy except treated skin cancer
- healthy Volunteers
- false
- maximum Age
- 65 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Mobilization with filgrastim autologous stem cell transplantation with melphalan conditioning stem cell infusion
- intervention Names
- Biological: filgrastim
- Drug: melphalan
- Procedure: autologous stem cell transplantation
- Procedure: stem cell infusion
- label
- 2nd Stem Cell Transplant
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- 2nd Stem Cell Transplant
- description
- 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of stem cell collection
- name
- filgrastim
- other Names
- G-CSF
- type
- BIOLOGICAL
- arm Group Labels
- 2nd Stem Cell Transplant
- description
- 140-200 mcg/kg IV over two days
- name
- melphalan
- other Names
- alkeran
- type
- DRUG
- arm Group Labels
- 2nd Stem Cell Transplant
- description
- infusion of previously collected stem cells on Day 0
- name
- autologous stem cell transplantation
- type
- PROCEDURE
- arm Group Labels
- 2nd Stem Cell Transplant
- description
- infusion of previously collected stem cells on Day 0
- name
- stem cell infusion
- type
- PROCEDURE
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 12
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
- measure
- Feasibility and Tolerability
- time Frame
- 3 months after treatment and annually
- description
- Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
- measure
- Response and Durability of Response
- time Frame
- 3 months after treatment and annually
- description
- Evaluate immune reconstitution based on time to engraftment
- measure
- Evaluate Immune Reconstitution
- time Frame
- 3 months after treatment and annually
Full study description
- brief Summary
- 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 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 autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.
- detailed Description
- OBJECTIVES: * Determine the feasibility and tolerability of second autologous stem cell transplantation in patients with persistent or recurrent AL amyloidosis. * Determine the response rate and durability of response in patients treated with this regimen. * Determine immune reconstitution in patients treated with this regimen. OUTLINE: * Mobilization: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning before the initiation of stem cell collection and continuing until the day before the completion of stem cell collection. * Preparative regimen: Patients receive high-dose melphalan IV over 20 minutes on days -3 and -2. * Autologous stem cell transplantation: Autologous stem cells are reinfused on day 0. Patients are followed at 6 months, 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 19 patients will be accrued for this study within 5-6 years.
Source references
Source notices and limitations
Discovery and provenance
- release id
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- query cond
- Plasma Cell Neoplasms
- query disease state id
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- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
- source file sha256
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- source string sha256
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Preserved source evidence · Not medical advice