Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib
NCT ID: NCT02489500
Last Updated: 2018-09-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
3 participants
INTERVENTIONAL
2015-06-30
2017-04-28
Brief Summary
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This study will compare the safety and effectiveness of standard treatment with high-dose melphalan and stem cell transplant, compared with investigational bortezomib when used in combination with standard treatment with high-dose melphalan and stem cell transplant for AL amyloidosis.
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Detailed Description
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Standard treatment for this disease is high-dose melphalan and stem cell transplant.
The purpose of this study is to compare the safety and effectiveness of standard treatment with high-dose melphalan and stem cell transplant, compared with investigational bortezomib when used in combination with standard treatment with high-dose melphalan and stem cell transplant for AL amyloidosis.
Patients enrolled in this study will receive either standard treatment with high-dose melphalan and stem cell transplant, or investigational bortezomib used in combination with standard treatment with high-dose melphalan and stem cell transplant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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melphalan
Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion
Melphalan
Conditioning Regimen:
Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0
Neupogen
granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days
Stem Cell Collection
collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells
Stem cell infusion
infusion of previously collected autologous stem cells
melphalan + Bortezomib
Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion
Bortezomib
Conditioning Regimen:
Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1
Melphalan
Conditioning Regimen:
Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0
Neupogen
granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days
Stem Cell Collection
collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells
Stem cell infusion
infusion of previously collected autologous stem cells
Interventions
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Bortezomib
Conditioning Regimen:
Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1
Melphalan
Conditioning Regimen:
Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0
Neupogen
granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days
Stem Cell Collection
collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells
Stem cell infusion
infusion of previously collected autologous stem cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Deposition of amyloid material by Congo red stain showing characteristic apple green birefringence,AND…
* evidence of a clonal plasma cell dyscrasia with monoclonal protein in the serum or urine by immunofixation electrophoresis studies AND/OR abnormal serum free light chain assay AND/OR clonal plasma cells in the bone marrow exam demonstrated by immunohistochemistry, flow cytometry or in situ hybridization AND…
* evidence of organ involvement other than carpal tunnel syndrome. Patients with senile, secondary, localized, dialysis-related or familial amyloidosis are not eligible. Confirmation of tissue diagnosis at all sites of organ dysfunction is encouraged, but not required.
2. Patients must be \> 18 years of age.
3. Patients must have a performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria
4. Patients must have left ventricular ejection fraction (LVEF) \> 45% by echocardiogram within 60 days of enrollment
5. Pulmonary Function Tests must show diffusing capacity of lung for carbon monoxide (DLCO) \> 50%.
6. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria
2. Prior chemotherapy with alkylating agent allowed only if no evidence of Myelodysplastic Dysplastic Syndrome (MDS) morphologically or cytogenetically. Total cumulative dose of oral melphalan must be \< 300 mg. Patients should not have received any cytotoxic therapy \< 4 weeks prior to registration and should have fully recovered from the effects of such therapy.
3. Patients must not have overt multiple myeloma (\>30% bone marrow plasmacytosis and, extensive (\>2) lytic lesions and hypercalcemia).
4. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
5. Patients must not be HIV positive.
6. Pregnant or nursing women may not participate. Women and men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
18 Years
ALL
No
Sponsors
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Boston Medical Center
OTHER
Responsible Party
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Vaishali Sanchorawala
Principal Investigator
Principal Investigators
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Vaishali Sanchorawala, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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VelRand
Identifier Type: OTHER
Identifier Source: secondary_id
H-33808
Identifier Type: -
Identifier Source: org_study_id
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