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NCT00128921 · STUDY IN CONTEXT

Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory 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

Parathyroid hormone: Any increase in PTH was considered response

Source null

→

primary · POSTED

Calcium: any Calcium increase would refer to a positive response.

Source null

→

primary · POSTED

Alkaline phosphatase: If the Alkaline phosphatase increases it's considered positive response

Source null

→

primary · POSTED

Magnesium: Any Magnesium increase would refer to a positive response.

Source null

→

primary · POSTED

Phosphate: any Phosphate increase would refer to a positive response.

Source null

→

secondary · POSTED

Osteocalcin: Any Osteocalcin increase means positive response.

Source null

→

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-darzalex-faspro-f9050675
nct id
NCT00128921
trial label
Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory 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
6
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0000
    source section id
    NCT00128921-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone
    endpoint definition
    Parathyroid hormone: Any increase in PTH was considered response
    time origin
    6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population 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-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0001
    source section id
    NCT00128921-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Calcium
    endpoint definition
    Calcium: any Calcium increase would refer to a positive response.
    time origin
    6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0003
    source section id
    NCT00128921-om-0003
    source outcome index
    3
    endpoint
    Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Alkaline Phosphatase
    endpoint definition
    Alkaline phosphatase: If the Alkaline phosphatase increases it's considered positive response
    time origin
    6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0004
    source section id
    NCT00128921-om-0004
    source outcome index
    4
    endpoint
    Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Magnesium
    endpoint definition
    Magnesium: Any Magnesium increase would refer to a positive response.
    time origin
    6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0005
    source section id
    NCT00128921-om-0005
    source outcome index
    5
    endpoint
    Number of Participants With a Positive Response to Bortezomib Measured by Bone Markers Like Phosphate.
    endpoint definition
    Phosphate: any Phosphate increase would refer to a positive response.
    time origin
    6 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0002
    source section id
    NCT00128921-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With a Positive Response to Bortezomib Measured by Bone Marker Osteocalcin
    endpoint definition
    Osteocalcin: Any Osteocalcin increase means positive response.
    time origin
    6 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    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-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort B
    regimen
    Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cohort B
    regimen
    Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Cohort B
    regimen
    Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11).
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Cohort B
    regimen
    Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Cohort B
    regimen
    Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Cohort A
    regimen
    Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
    analyzed count
    10
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Cohort B
    regimen
    Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00128921-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    harm key
    EG000
    source section id
    NCT00128921-ae
    event group key
    EG000
    event group label
    Bortezomib, Cohort a
    serious affected
    0
    serious at risk
    10
    other affected
    0
    other at risk
    10
    frequency threshold
    0
    collection period
    The adverse event data was collected for a period of 1 year and 9 months, between 4/17/2006 to 12/26/2007
    event definition
    Adverse event data for cohort b was collected only for 6 participants, as 8 participants were enrolled but 2 did not start the protocol step
    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-darzalex-faspro-f9050675
    nct id
    NCT00128921
    harm key
    EG001
    source section id
    NCT00128921-ae
    event group key
    EG001
    event group label
    Bortezomib, Cohort b
    serious affected
    1
    serious at risk
    6
    other affected
    0
    other at risk
    6
    frequency threshold
    0
    collection period
    The adverse event data was collected for a period of 1 year and 9 months, between 4/17/2006 to 12/26/2007
    event definition
    Adverse event data for cohort b was collected only for 6 participants, as 8 participants were enrolled but 2 did not start the protocol step
    undenominated note
    Source null
    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-multiple-myeloma-darzalex-faspro-f9050675
    nct id
    NCT00128921
    harm key
    EG002
    source section id
    NCT00128921-ae
    event group key
    EG002
    event group label
    Bortezomib, Cohort c
    serious affected
    0
    serious at risk
    0
    other affected
    0
    other at risk
    0
    frequency threshold
    0
    collection period
    The adverse event data was collected for a period of 1 year and 9 months, between 4/17/2006 to 12/26/2007
    event definition
    Adverse event data for cohort b was collected only for 6 participants, as 8 participants were enrolled but 2 did not start the protocol step
    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