NCT01072773 · REGISTRY CONDITION SEARCH

Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain 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: 2014-04-02

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and dexamethasone together works in treating patients with primary systemic light chain 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

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Participants With a Confirmed Hematologic Response

→

outcome · POSTED

Number of Participants With Treatment Related Adverse Events.

→

outcome · POSTED

Number of Participants With an Organ Response.

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Time to Disease Progression

→

outcome · POSTED

Duration of Response

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: * Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens * Measurable disease of amyloid light chain amyloidosis as defined by at least ONE of the following: serum monoclonal protein \>= 1.0 g by protein electrophoresis, \> 200 mg of monoclonal protein in the urine on 24 hour electrophoresis, serum free light-chain \>= 7.5 mg/dL with an abnormal kappa:lambda ratio * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 * Absolute neutrophil count \>= 1000/uL * Platelet \>= 75000/uL * Total bilirubin \< 3.0 mg/dL * Aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) * Creatinine clearance \>= 30ml/min * Women of childbearing potential should have a negative serum or urine pregnancy test done =\< 7 days prior to registration, and should be willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study * Male subject agrees to use an acceptable method for contraception for the duration of the study * Previously treated amyloidosis; no limit to prior therapy provided there is adequate residual organ function * Symptomatic organ involvement (heart, kidney, liver/GI tract, peripheral nervous system or soft tissue); carpal tunnel syndrome skin purpura, or the presence of vascular amyloid on a bone marrow biopsy alone are not sufficient to meet criteria for "symptomatic organ involvement" * Renal involvement is defined as proteinuria (predominantly albumin) \> 0.5 g/day in a 24- hour urine collection * Cardiac involvement is defined as the presence of a mean left ventricular wall thickness on echocardiogram greater than 12 mm in the absence of a history of hypertension or valvular heart disease, or in the presence of unexplained low voltage (\< 0.5 mV) on the electrocardiogram * Hepatic involvement is defined as hepatomegaly (\>= 2 cm below costal margin) on physical exam or an alkaline phosphatase \> 1.5 x ULN * Peripheral nerve involvement is defined based on clinical history or abnormal sensory and/or motor findings on neurologic exam * Autonomic nerve involvement is defined as orthostasis, symptoms of nausea or dysgeusia, gastric atony by gastric emptying scan, diarrhea or constipation * Soft tissue and lymphatic involvement may be ascertained based on classic physical exam findings (macroglossia, shoulder pad sign, raccoon eyes, carpal tunnel syndrome, synovial enlargement, firm enlarged lymph nodes) or biopsy * Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by subject any time without prejudice to future medical care * Willingness to return to Mayo Clinic enrolling institution for follow-up Exclusion Criteria: * Melphalan or other myelosuppressive agents =\< 3 weeks prior to registration; non-myelosuppressive agents like thalidomide, or high dose corticosteroids \<= 1week prior to registration * Concurrent use of corticosteroids, but patients may be on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than amyloid, i.e., adrenal insufficiency, rheumatoid arthritis, etc * Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: pregnant women and nursing women * Other active malignancy =\< 2 years prior to registration; EXCEPTIONS: Nonmelanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving any specific treatment for their cancer * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens including psychiatric illness/social situations that would limit compliance with study requirements * Known to be HIV positive * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * Clinically overt multiple myeloma (monoclonal Bone Marrow Plasma Count \> 30%), and at least one of the following: bone lesions or hypercalcemia * History of myocardial infarction =\< 6 months, or requiring use of ongoing maintenance drug therapy for life-threatening ventricular arrhythmias * Grade 3 sensory or grade 1 painful peripheral neuropathy * Known hypersensitivity to bortezomib, boron or mannitol * Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure or troponin T \> 0.1 ng/mL
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
intervention Names
Drug: bortezomib
Drug: cyclophosphamide
Drug: dexamethasone
label
Bortez/Cyc/Dex
type
EXPERIMENTAL

interventions

arm Group Labels
Bortez/Cyc/Dex
description
1.3 mg/m\^2, by IV on days 1, 8 and 15 every 28 days
name
bortezomib
other Names
LDP 341
MLN341
PS-341
VELCADE
type
DRUG
arm Group Labels
Bortez/Cyc/Dex
description
300 mg/m\^2, orally, on days 1, 8, 15 \& 22 every 28 days.
name
cyclophosphamide
other Names
CPM
CTX
Cytoxan
Endoxan
Endoxana
Enduxan
type
DRUG
arm Group Labels
Bortez/Cyc/Dex
description
40 mg, orally, on days 1, 8, 15 \& 22 every 28 days
name
dexamethasone
other Names
Aeroseb-Dex
Decaderm
Decadron
Decaspray
DM
DXM
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 2
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Response that was confirmed on 2 consecutive evaluations during treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
measure
Number of Participants With a Confirmed Hematologic Response
time Frame
Duration of treatment (up to 12 cycles/months)

secondary Outcomes

description
Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE. Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE Adverse events will be assessed using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0.
measure
Number of Participants With Treatment Related Adverse Events.
time Frame
Duration on treatment (up to 12 cycles/months)
description
The number of patients that acheived a response in an affected organ.
measure
Number of Participants With an Organ Response.
time Frame
Duration on treatment (up to 12 cycles/months)
description
Survival time is defined as the time from registration to death due to any cause.
measure
Overall Survival
time Frame
Duration of Study (up to 5 years)
description
Time to disease progression is defined as the time from registration to the earliest date of documented disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had tumor progression at the time of their death
measure
Time to Disease Progression
time Frame
Duration of Study (up to 5 years)
description
Duration of response will be calculated from the date of first evidence of response until the date of progression in the subset of patients with confirmed hematologic responses.
measure
Duration of Response
time Frame
Duration of Study (up to 5 years)

Full study description

brief Summary: RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and dexamethasone together works in treating patients with primary systemic light chain amyloidosis.
detailed Description: PRIMARY OBJECTIVE: I. To assess the confirmed hematologic response rate of the combination of bortezomib, cyclophosphamide and dexamethasone in patients with primary systemic amyloidosis. SECONDARY OBJECTIVES: I. Organ response rate of the bortezomib, cyclophosphamide and dexamethasone combination. II. Severity and frequency of adverse events associated with bortezomib, cyclophosphamide and dexamethasone treatment in patients with primary systemic amyloidosis. III. Time to progression. IV. Survival. OUTLINE: Patients receive bortezomib IV on days 1, 8, and 15 and oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-62e4ee04bfa221898fb4
requested nct id
NCT01072773
primary nct id
NCT01072773
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
a08432df8e61e3530b0a618e1c0ea1b2ca070f6c726923f10a53cdea05d84e4c
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-62e4ee04bfa221898fb4
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT01072773
occurrences
context exact
NCT01072773
end
11
exact text
NCT01072773
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
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
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/958/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
c8a153de3741928377a95bd971260f746e5ad935e4c2513a7f03f0eb78853ed7
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