Skip to content
Triangle logo TriangleGet started
← Study library

NCT00681044 · REGISTRY CONDITION SEARCH

HD Melphalan and SCT in Patients With IGDD or LCDD

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
TERMINATED
Registry last update
2017-04-28

RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer 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 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 the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition 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

→

baseline

Baseline characteristics

→

outcome · POSTED

Hematologic Response Rate

→

outcome · POSTED

Predictability of Early Free Light-chain Response for Heme Response

→

outcome · POSTED

Organ or Clinical Response

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Tolerability

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed light-chain deposition disease based on the following criteria: * Deposition of granular material containing free light-chain (FLC) immunoglobulins that did not bind Congo red * Evidence of a plasma cell dyscrasia, as defined by any of the following: * Monoclonal gammopathy in the serum or urine by immunofixation electrophoresis * Clonal plasmacytosis on bone marrow biopsy by immuno-histochemical * Elevated serum levels of FLC * Patients may enroll after stem cell collection (SCC) if all prestudy requirements are completed prior to starting SCC (i.e., ≥ 2.5 x 10\^6 cells available for transplantation) PRIOR CONCURRENT THERAPY: * Prior chemotherapy with alkylating agent allowed provided there is no evidence of myelodysplastic syndromes * Prior total dose of melphalan \< 300 mg * More than 4 weeks since prior cytotoxic therapy and recovered PATIENT CHARACTERISTICS: * Performance status 0-2 * Left Ventricular Ejection Fraction (LVEF) ≥ 45% within the past 90 days * diffusing capacity of lung for carbon monoxide (DLCO) ≥ 50% Exclusion Criteria: * No overt multiple myeloma, as defined by any of the following: * Greater than 30% bone marrow plasmacytosis * Extensive (i.e., \> 2) lytic lesions * Hypercalcemia * No myocardial infarction, congestive heart failure, or arrhythmia refractory to therapy within the past 6 months * No prior malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer from which the patient is currently in complete response, or any other cancer from which the patient has been disease-free for the past 5 years * No HIV positivity
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Mobilization with Filgrastim Stem Cell Transplant Melphalan Conditioning Stem Cell infusion
    intervention Names
    1. Biological: filgrastim
    2. Drug: melphalan
    3. Procedure: Stem Cell Infusion
    label
    SCT with melphalan conditioning
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. SCT with melphalan conditioning
    description
    16 mcg/kg daily beginning 3 days prior to SCC through day before final SCC
    name
    filgrastim
    other Names
    1. G-CSF, neulasta
    type
    BIOLOGICAL
  2. arm Group Labels
    1. SCT with melphalan conditioning
    description
    70-100 mg/m2/day will be administered intravenously on Days -3 and -2
    name
    melphalan
    other Names
    1. alkeran
    type
    DRUG
  3. arm Group Labels
    1. SCT with melphalan conditioning
    description
    infusion of previously collected stem cells on Day 0
    name
    Stem Cell Infusion
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
5
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Hematologic Response Rate
    time Frame
    one year
secondary Outcomes
  1. measure
    Predictability of Early Free Light-chain Response for Heme Response
    time Frame
    One month
  2. measure
    Organ or Clinical Response
    time Frame
    One year
  3. measure
    Overall Survival
    time Frame
    life
  4. measure
    Tolerability
    time Frame
    100 days
Full study description
brief Summary
RATIONALE: Giving chemotherapy before a stem cell transplant stops the growth of cancer 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 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 the side effects of high-dose melphalan given together with stem cell transplant and to see how well it works in treating patients with immunoglobulin deposition disease or light-chain deposition disease.
detailed Description
OBJECTIVES: * To assess the tolerability of high-dose melphalan and autologous stem cell transplantation in patients with immunoglobulin deposition disease or light-chain deposition disease. * To determine the hematologic response rate in patients treated with this regimen. * To determine the predictability of early free light-chain response for heme response in patients treated with this regimen. * To determine organ or clinical response in patients treated with this regimen. * To determine overall survival of these patients. OUTLINE: * Stem cell mobilization: Patients undergo blood stem cell mobilization comprising filgrastim (G-CSF) subcutaneously once daily for 3 days (i.e., through the day before the last stem cell collection). * Stem cell collection: Patients undergo collection of G-CSF-mobilized blood stem cells until the target number of stem cells (at least 2 x 10\^6 cluster of differentiation-34-positive cells) is reached. * Conditioning regimen: Patients receive high-dose melphalan IV on days -3 to -2. * Autologous stem cell transplantation: Patients undergo blood stem cell infusion on day 0. After completion of study therapy, patients are followed at 3, 6, and 12 months and then annually thereafter.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-523b9b249f96a3dd2dd7
      requested nct id
      NCT00681044
      primary nct id
      NCT00681044
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      f61b5b8281f834a98709317598003056a2aa82c9b92a292e3623f400c9c3291b
      payload sha256
      b312778937775f8395dd3aac5519d3692eef52c6caa0e5bee6888062dc5d6078
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-523b9b249f96a3dd2dd7
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00681044
      occurrences
      1. context exact
        NCT00681044
        end
        11
        exact text
        NCT00681044
        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-001.json
      source file sha256
      f61b5b8281f834a98709317598003056a2aa82c9b92a292e3623f400c9c3291b
      source json pointer
      /studies/60/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      70adbaeecac74bf4ae5cdf02f5dd2d423b7a350cc83cd4a2023fcf020628c0f7

    Preserved source evidence · Not medical advice