NCT02489500 · REGISTRY CONDITION SEARCH

Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: TERMINATED
Registry last update: 2018-09-10

Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant. 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.

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

Toxicities

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outcome · POSTED

Overall Survival

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outcome · POSTED

Number of Participants With Organ Response

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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: 1. Histological diagnosis of primary systemic (AL) amyloidosis based on: * 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: 1. Patients with recent (\< 6 months) myocardial infarction, congestive heart failure, New York Heart Association (NYHA) class III/IV or arrhythmia which are refractory to medical therapy are ineligible. 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion
intervention Names
Drug: Melphalan
Drug: Neupogen
Procedure: Stem Cell Collection
Procedure: Stem cell infusion
label
melphalan
type
ACTIVE_COMPARATOR
description
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
intervention Names
Drug: Bortezomib
Drug: Melphalan
Drug: Neupogen
Procedure: Stem Cell Collection
Procedure: Stem cell infusion
label
melphalan + Bortezomib
type
EXPERIMENTAL

interventions

arm Group Labels
melphalan + Bortezomib
description
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
name
Bortezomib
other Names
VELCADE
type
DRUG
arm Group Labels
melphalan
melphalan + Bortezomib
description
Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0
name
Melphalan
other Names
Alkeran
type
DRUG
arm Group Labels
melphalan
melphalan + Bortezomib
description
granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days
name
Neupogen
other Names
granulocyte colony-stimulating factor (G-CSF)
type
DRUG
arm Group Labels
melphalan
melphalan + Bortezomib
description
collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells
name
Stem Cell Collection
other Names
apheresis
type
PROCEDURE
arm Group Labels
melphalan
melphalan + Bortezomib
description
infusion of previously collected autologous stem cells
name
Stem cell infusion
other Names
infusion
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 3
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains
measure
Number of Participants With Hematologic Response
time Frame
6 months

secondary Outcomes

description
Number of serious adverse events per participant based on Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
measure
Toxicities
time Frame
100 days
description
duration of overall survival measured in days
measure
Overall Survival
time Frame
5 years
description
analysis of number of patients with organ response, as defined on page 13 of the detailed protocol for kidney, heart and liver.
measure
Number of Participants With Organ Response
time Frame
5 years

Full study description

brief Summary: Standard treatment for AL Amyloidosis is high-dose melphalan and stem cell transplant. 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.
detailed Description: This study seeks to enroll patients with AL amyloidosis who have been recommended for standard treatment with high-dose melphalan and stem cell transplant. 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.

Source references

Source notices and limitations

Discovery and provenance

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source kind
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exact text
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start
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offset unit
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query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
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source file sha256
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source kind
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source record id
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source string sha256
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice