S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or 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

Responses are defined as follows: Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%. Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein \< 0.2gm/day. Bone marrow plasma cells must be ≤ 5%. Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level.

Ninety patients is sufficient to distinguish between the null hypothesis that the response rate is 45% versus the alternative of a response rate of 60% with 89% power, using a one-sided test based on the binomial distribution with a significance level of 5%.

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secondary · POSTED

To evaluate the qualitative and quantitative toxicities associated with this regimen.

All participants receiving at least one dose of induction therapy

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secondary · POSTED

From date of initial registration to date of progression/relapse of disease (\> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years

With ninety patients, we will have 82% power to rule out a null hypothesis of a 12-month median survival versus an alternative hypothesis of an 18-month median survival at a significance level of 5%.

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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: NCT00124579
trial label: S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or 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: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00124579
outcome key
om-0001
source section id
NCT00124579-om-0001
source outcome index
1
endpoint
Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).
endpoint definition
Responses are defined as follows: Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%. Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein \< 0.2gm/day. Bone marrow plasma cells must be ≤ 5%. Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level.
time origin
1 year
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Ninety patients is sufficient to distinguish between the null hypothesis that the response rate is 45% versus the alternative of a response rate of 60% with 89% power, using a one-sided test based on the binomial distribution with a significance level of 5%.
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-sarclisa-escena-9eb42ed1
nct id
NCT00124579
outcome key
om-0000
source section id
NCT00124579-om-0000
source outcome index
0
endpoint
Toxicity Evaluation
endpoint definition
To evaluate the qualitative and quantitative toxicities associated with this regimen.
time origin
From date of protocol therapy start to date of protocol therapy end, i.e., up to about 3.5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants receiving at least one dose of induction therapy
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-sarclisa-escena-9eb42ed1
nct id
NCT00124579
outcome key
om-0002
source section id
NCT00124579-om-0002
source outcome index
2
endpoint
Progression-Free Survival
endpoint definition
From date of initial registration to date of progression/relapse of disease (\> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years
time origin
about 12-18 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
With ninety patients, we will have 82% power to rule out a null hypothesis of a 12-month median survival versus an alternative hypothesis of an 18-month median survival at a significance level of 5%.
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-sarclisa-escena-9eb42ed1
nct id
NCT00124579
outcome key
om-0000
arm key
OG000
arm label
Bortezomib + Thal/Dex
regimen
Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21). Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00124579-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00124579
outcome key
om-0001
arm key
OG000
arm label
Bortezomib With Thalidomide and Dexamethasone
regimen
Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21). Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00124579-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00124579
outcome key
om-0002
arm key
OG000
arm label
Bortezomib With Thalidomide and Dexamethasone
regimen
Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21). Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00124579-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma-sarclisa-escena-9eb42ed1
nct id
NCT00124579
harm key
EG000
source section id
NCT00124579-ae
event group key
EG000
event group label
Bortezomib + Thal/Dex
serious affected
1
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
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