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← refractory Multiple Myeloma

NCT00217438 · STUDY IN CONTEXT

Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. "Near" Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey.

Per protocol, patients who completed the day 80-120 evaluation assessments.

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secondary · POSTED

Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Patients who were treated per protocol.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-refractory-b00a2fc0
nct id
NCT00217438
trial label
Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma
applicability
unclear
applicability note
Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
2
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-refractory-b00a2fc0
    nct id
    NCT00217438
    outcome key
    om-0000
    source section id
    NCT00217438-om-0000
    source outcome index
    0
    endpoint
    CR and Near CR Rates
    endpoint definition
    Per modified European Group for Blood and Marrow Transplant (EBMT) response criteria for definition of response in patients with multiple myeloma treated by high-dose therapy and stem cell transplantation: Complete Response (CR): Complete disappearance of all clinically measurable disease, complete response requires negative tests for monoclonal proteins in serum and urine by immunofixation, no monoclonal plasma cells in marrow specimen by flow cytometry and no evidence of progressive bone disease by skeletal survey. "Near" Complete Response (nCR): Less than 0.1 gram/dL monoclonal protein detectable in serum by standard protein electrophoresis and less than 50 mg monoclonal protein detectable in urine on 24 hour collection. Less than 5% monoclonal plasma cells detectable in bone marrow by immunohistochemistry. No evidence of progressive bone disease by skeletal survey.
    time origin
    Up to 120 days after transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Per protocol, patients who completed the day 80-120 evaluation assessments.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-refractory-b00a2fc0
    nct id
    NCT00217438
    outcome key
    om-0001
    source section id
    NCT00217438-om-0001
    source outcome index
    1
    endpoint
    Relative Toxicities Between Melphalan 280 mg/m^2 or Melphalan 200 mg/m^2
    endpoint definition
    Number of Grade 3-4 adverse events observed in each group from enrollment through the Day 80-120 evaluation. Grade 3-4 events are defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
    time origin
    Up to day 56 after transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Patients who were treated per protocol.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-refractory-b00a2fc0
    nct id
    NCT00217438
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)
    regimen
    INDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217438-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-refractory-b00a2fc0
    nct id
    NCT00217438
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)
    regimen
    INDUCTION THERAPY: Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217438-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-refractory-b00a2fc0
    nct id
    NCT00217438
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)
    regimen
    INDUCTION THERAPY: Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217438-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-refractory-b00a2fc0
    nct id
    NCT00217438
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)
    regimen
    INDUCTION THERAPY: Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose. AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0. Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT. Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy.
    analyzed count
    64
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00217438-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-refractory-b00a2fc0
    nct id
    NCT00217438
    harm key
    EG000
    source section id
    NCT00217438-ae
    event group key
    EG000
    event group label
    Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)
    serious affected
    0
    serious at risk
    66
    other affected
    14
    other at risk
    66
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-refractory-b00a2fc0
    nct id
    NCT00217438
    harm key
    EG001
    source section id
    NCT00217438-ae
    event group key
    EG001
    event group label
    Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)
    serious affected
    0
    serious at risk
    64
    other affected
    7
    other at risk
    64
    frequency threshold
    0
    collection period
    Source null
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice