NCT00790647 · REGISTRY CONDITION SEARCH

Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic 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: COMPLETED
Registry last update: 2017-02-06

RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib followed by stem cell transplant works in treating patients with primary systemic 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.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Hematologic Response

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outcome · POSTED

Number of Participants Surviving at 100 Days From Transplant

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outcome · POSTED

Number of Participants Surviving at 1 Year

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outcome · POSTED

Number of Participants Surviving at 2 Years

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion criteria: DISEASE CHARACTERISTICS: * Histologically confirmed primary systemic amyloidosis based on the following criteria: * Amyloid light-chain disease * Deposition of amyloid material by congo red stain showing characteristic green birefringence * Monoclonal light chain protein (Bence Jones protein) in the serum or urine, immunohistochemical studies, or serum free light chain assay * Evidence of tissue involvement other than carpal tunnel syndrome (i.e., positive immunohistochemical staining of bone marrow demonstrating clonal plasma cells); tissue amyloid deposits with anti-kappa or anti-lambda anti-serum; evidence for a plasma cell dyscrasia by serum/urine or bone marrow; or overwhelmingly convincing clinical features (e.g., macroglossia) associated with other systemic manifestations PATIENT CHARACTERISTICS: * Southwest Oncology Group performance status 0-1 * Fertile patients must use effective contraception * Left ventricular ejection fraction ≥ 45% by Echocardiogram within the past 60 days * diffusion capacity of lung for carbon monoxide ≥ 50% PRIOR CONCURRENT THERAPY: * Prior chemotherapy with alkylating agent allowed provided there is no morphological or cytogenetic evidence of myelodysplastic syndromes * Prior total cumulative dose of oral melphalan \< 300 mg * At least 4 weeks since prior cytotoxic therapy and fully recovered Exclusion criteria: * No senile, secondary, localized, dialysis-related, or familial amyloidosis * No overt multiple myeloma (\> 30% of bone marrow plasmacytosis, extensive \[\> 2\] lytic lesions, or hypercalcemia) * Not pregnant or nursing * No myocardial infarction within the past 6 months, congestive heart failure, or arrhythmia refractory to therapy * No prior malignancy except for any of the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I or II cancer currently in complete remission * Any cancer from which the patient has been disease-free ≥ 5 years * No advanced (grade 3-4) pre-existing neuropathy * No HIV positivity
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 Stem Cell Collection Bortezomib Melphalan Stem Cell infusion
intervention Names
Biological: filgrastim
Drug: bortezomib
Drug: melphalan
Procedure: Stem Cell Infusion
label
Stem Cell Transplant with Bortezomib and Melphalan
type
EXPERIMENTAL

interventions

arm Group Labels
Stem Cell Transplant with Bortezomib and Melphalan
description
16 mcg/kg daily beginning 3 days before stem cell collection through day before final stem cell collection
name
filgrastim
other Names
Growth-Colony Stimulating Factor, neupogen
type
BIOLOGICAL
arm Group Labels
Stem Cell Transplant with Bortezomib and Melphalan
description
1.0 mg/m2/dose D -6, D-3, D +1, D + 4
name
bortezomib
other Names
velcade
type
DRUG
arm Group Labels
Stem Cell Transplant with Bortezomib and Melphalan
description
100 mg/m2/dose D -2, D -1
name
melphalan
other Names
alkeran
type
DRUG
arm Group Labels
Stem Cell Transplant with Bortezomib and Melphalan
description
infusion of previously collected autologous stem cells
name
Stem Cell Infusion
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 10
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
complete and partial hematologic response defined as: Complete response: absence of detectable monoclonal protein in serum and urine, and bone marrow biopsy \<5% plasma cells with no clonal predominance of kappa or lambda isotype. Partial response: any one of the following 1. For patients with detectable and quantifiable marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. 2. For patients with a detectable monoclonal peak on serum protein electropheresis or urine protein electropheresis, a reduction in the peak height of 50% or more. 3. For patients with quantifiable urinary kappa or lambda chain concentration, a reduction in daily light chain excretion (concentration x 24-hr urine volume).
measure
Number of Participants With Hematologic Response
time Frame
one year

secondary Outcomes

measure
Number of Participants Surviving at 100 Days From Transplant
time Frame
100 Days from transplant date
measure
Number of Participants Surviving at 1 Year
time Frame
one year from transplant
measure
Number of Participants Surviving at 2 Years
time Frame
2 years from transplant

Full study description

brief Summary: RATIONALE: Giving melphalan and bortezomib before and after a stem cell transplant stops the growth of abnormal cells by stopping them from dividing or killing them. Giving colony-stimulating factors and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy and monoclonal antibody therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This phase II trial is studying how well giving melphalan together with bortezomib followed by stem cell transplant works in treating patients with primary systemic amyloidosis.
detailed Description: OBJECTIVES: * To determine if hematologic responses to high-dose melphalan and autologous stem cell transplantation increase with addition of bortezomib in the conditioning regimen in patients with primary systemic amyloidosis. OUTLINE: * Autologous stem cell mobilization and collection: Patients receive filgrastim to mobilize stem cells, which are then collected. * Conditioning regimen: Patients receive bortezomib intravenously on days -6, -3, 1, and 4 and oral high-dose melphalan on days -2 and -1. * Stem cell transplantation: Patients undergo autologous stem cell transplantation on day 0. After completion of study therapy, patients are followed every 6 months for 1 year and annually thereafter.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice