NCT00006184 · STUDY IN CONTEXT

Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma

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

Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) \> 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells.

This outcome measure was only pre-specified to be measured in the recipient Arm/Group.

→

primary · POSTED

Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.

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
nct id: NCT00006184
trial label: Chemotherapy, Stem Cell Transplantation and Donor and Patient Vaccination for Treatment of Multiple Myeloma
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: 2
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00006184
outcome key
om-0000
source section id
NCT00006184-om-0000
source outcome index
0
endpoint
Immune Response
endpoint definition
Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) \> 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells.
time origin
105 days
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
This outcome measure was only pre-specified to be measured in the recipient Arm/Group.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00006184
outcome key
om-0001
source section id
NCT00006184-om-0001
source outcome index
1
endpoint
Number of Participants With Adverse Events
endpoint definition
Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
time origin
9 years
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

arms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00006184
outcome key
om-0000
arm key
OG000
arm label
Recipient - Chemotherapy Group
regimen
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00006184-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00006184
outcome key
om-0001
arm key
OG000
arm label
Recipient - Chemotherapy Group
regimen
Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00006184-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00006184
outcome key
om-0001
arm key
OG001
arm label
Donor - Vaccination Generation Group
regimen
3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m\^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00006184-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00006184
harm key
EG000
source section id
NCT00006184-ae
event group key
EG000
event group label
Recipient - Chemotherapy Group
serious affected
10
serious at risk
10
other affected
10
other at risk
10
frequency threshold
0
collection period
9 years
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
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00006184
harm key
EG001
source section id
NCT00006184-ae
event group key
EG001
event group label
Donor - Vaccination Generation Group
serious affected
0
serious at risk
10
other affected
10
other at risk
10
frequency threshold
0
collection period
9 years
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