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NCT00458822 · REGISTRY CONDITION SEARCH

Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated 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
2016-08-10

The purpose of this study in patients needing treatment for AL amyloidosis is to see how well treatment with IV melphalan works and then, if some clonal plasma cells are still present about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and dexamethasone works to reduce the rest of the clonal plasma cell disease.

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

Hematologic and 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
DISEASE CHARACTERISTICS: * Histologically confirmed amyloidosis * Diagnosed within the past 12 months * Clonal plasma cell disorder, as demonstrated by any of the following: * Presence of M-protein in serum and/or urine by immunofixation and/or serum free light chain assay * Clonal population of plasma cells in the bone marrow based on kappa/lambda staining of a marrow biopsy * Negative genetic testing for hereditary forms of amyloidosis * No amyloid-specific syndrome (e.g., carpal tunnel syndrome or skin purpura) as the only evidence of disease * Vascular amyloidosis only in a bone marrow biopsy specimen or in plasmacytoma is not indicative of systemic amyloidosis * No advanced cardiac amyloidosis * Must have symptomatic involvement of no more than 2 of the following visceral organ systems: * Kidneys * Liver/gastrointestinal * Peripheral/autonomic nervous system * Heart * No persistent pleural effusions * No clinically overt multiple myeloma with \> 30% plasma cells in the bone marrow or lytic bone lesions * Able to undergo autologous stem cell transplantation PATIENT CHARACTERISTICS: * SWOG performance status 0-3 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Bilirubin \< 2.0 mg/dL * Creatinine clearance \< 51 mL/min allowed * LVEF \> 45% by echocardiogram * No New York Heart Association class III-IV congestive heart failure * No history of cardiac syncope * No recurrent symptomatic arrhythmias * No oxygen-dependent restrictive cardiomyopathy * No myocardial infarction within the past 6 months * Pulmonary diffusion capacity \> 50% predicted by pulmonary function testing * No uncontrolled infection * No other active malignancy, except for any of the following: * Adequately treated basal cell or squamous cell skin cancer * In situ cervical cancer * Adequately treated stage I cancer from which the patient is currently in complete remission * Any other cancer from which the patient has been disease-free for 5 years * No hypersensitivity to bortezomib, boron, or mannitol * No HIV positivity * No serious medical or psychiatric illness that would preclude study compliance PRIOR CONCURRENT THERAPY: * At least 14 days since prior investigational drugs * No prior therapy for monoclonal plasma disease
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
    intervention Names
    1. Drug: bortezomib
    2. Drug: dexamethasone
    label
    All Patients
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. All Patients
    description
    Given IV
    name
    bortezomib
    type
    DRUG
  2. arm Group Labels
    1. All Patients
    description
    Given orally
    name
    dexamethasone
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
40
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.
    measure
    Hematologic and Organ Response
    time Frame
    2-3 months post transplant
Full study description
brief Summary
The purpose of this study in patients needing treatment for AL amyloidosis is to see how well treatment with IV melphalan works and then, if some clonal plasma cells are still present about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and dexamethasone works to reduce the rest of the clonal plasma cell disease.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-e6c4deb9e03f8100b500
      requested nct id
      NCT00458822
      primary nct id
      NCT00458822
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      18dc7be0de01496f5f82ef3c91e153842bbcca844d2df98ecef124a4828c41de
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-e6c4deb9e03f8100b500
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT00458822
        end
        11
        exact text
        NCT00458822
        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/597/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      0317c933ce642899434483b48984a9947b78dca1efd987c914612e01d7e919ca

    Preserved source evidence · Not medical advice