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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00790647
Other study ID # CDR0000618857
Secondary ID BUMC-H-27277
Status Completed
Phase Phase 2
First received November 12, 2008
Last updated January 14, 2016
Start date June 2008
Est. completion date November 2014

Study information

Verified date March 2015
Source Boston Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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, such as G-CSF, 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.


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 (G-CSF) to mobilize stem cells, which are then collected.

- Conditioning regimen: Patients receive bortezomib IV 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date November 2014
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 PCD by serum/urine or bone marrow; or overwhelmingly convincing clinical features (e.g., macroglossia) associated with other systemic manifestations

PATIENT CHARACTERISTICS:

- SWOG performance status 0-1

- Fertile patients must use effective contraception

- LVEF = 45% by ECHO within the past 60 days

- DLCO = 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
filgrastim
16 mcg/kg daily beginning 3 days before SCC through day before final SCC
Drug:
bortezomib
1.0 mg/m2/dose D -6, D-3, D +1, D + 4
melphalan
100 mg/m2/dose D -2, D -1
Procedure:
Stem Cell Infusion
infusion of previously collected autologous stem cells

Locations

Country Name City State
United States Boston University Cancer Research Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hematologic response (complete and partial) one year No
Secondary Tolerability 100 Days from transplant date Yes
Secondary Survival at 1 and 2 years year one and two No
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