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← Plasma Cell Neoplasms

NCT00075608 · STUDY IN CONTEXT

2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. 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

Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events

No data were collected or analyzed due to study termination

→

primary · POSTED

Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death

No data were collected or analyzed due to study termination

→

primary · POSTED

Evaluate immune reconstitution based on time to engraftment

No data were collected or analyzed due to study termination

→

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-plasma-cell-neoplasms
nct id
NCT00075608
trial label
2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
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
3
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms
    nct id
    NCT00075608
    outcome key
    om-0000
    source section id
    NCT00075608-om-0000
    source outcome index
    0
    endpoint
    Feasibility and Tolerability
    endpoint definition
    Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events
    time origin
    3 months after treatment and annually
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No data were collected or analyzed due to study termination
    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-plasma-cell-neoplasms
    nct id
    NCT00075608
    outcome key
    om-0001
    source section id
    NCT00075608-om-0001
    source outcome index
    1
    endpoint
    Response and Durability of Response
    endpoint definition
    Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death
    time origin
    3 months after treatment and annually
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No data were collected or analyzed due to study termination
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms
    nct id
    NCT00075608
    outcome key
    om-0002
    source section id
    NCT00075608-om-0002
    source outcome index
    2
    endpoint
    Evaluate Immune Reconstitution
    endpoint definition
    Evaluate immune reconstitution based on time to engraftment
    time origin
    3 months after treatment and annually
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    No data were collected or analyzed due to study termination
    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-plasma-cell-neoplasms
    nct id
    NCT00075608
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Second Transplant
    regimen
    Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075608-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms
    nct id
    NCT00075608
    outcome key
    om-0001
    arm key
    OG000
    arm label
    2nd SCT
    regimen
    Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning filgrastim: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of SCC melphalan: 140-200 mcg/kg IV over two days autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0 peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075608-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms
    nct id
    NCT00075608
    outcome key
    om-0002
    arm key
    OG000
    arm label
    2nd SCT
    regimen
    Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning filgrastim: 16mcg/kg IV daily beginning three days prior to SCC through last day of SCC melphalan: 140-200 mcg/kg IV over two days autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0 peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00075608-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-plasma-cell-neoplasms
    nct id
    NCT00075608
    harm key
    EG000
    source section id
    NCT00075608-ae
    event group key
    EG000
    event group label
    Second Transplant
    serious affected
    12
    serious at risk
    12
    other affected
    12
    other at risk
    12
    frequency threshold
    5
    collection period
    1 year
    event definition
    Adverse events were assessed for up to 1 year.
    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