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NCT00307086 · STUDY IN CONTEXT

Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants

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

Median overall survival after first peripheral blood stem cell transplant (PBSCT).

All evaluable participants

→

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-sarclisa-escena-9eb42ed1
nct id
NCT00307086
trial label
Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants
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
1
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00307086
    outcome key
    om-0000
    source section id
    NCT00307086-om-0000
    source outcome index
    0
    endpoint
    Overall Survival (OS)
    endpoint definition
    Median overall survival after first peripheral blood stem cell transplant (PBSCT).
    time origin
    40 months post transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All evaluable participants
    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-sarclisa-escena-9eb42ed1
    nct id
    NCT00307086
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Autologous PBSCT
    regimen
    bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1) Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes
    analyzed count
    25
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00307086-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-sarclisa-escena-9eb42ed1
    nct id
    NCT00307086
    harm key
    EG000
    source section id
    NCT00307086-ae
    event group key
    EG000
    event group label
    Autologous PBSCT
    serious affected
    25
    serious at risk
    25
    other affected
    0
    other at risk
    25
    frequency threshold
    5
    collection period
    2 years post transplant
    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